Trial Outcomes & Findings for A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma (NCT NCT02279719)
NCT ID: NCT02279719
Last Updated: 2023-11-15
Results Overview
To assess the dose limiting toxicities for phase IB
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
97 participants
Primary outcome timeframe
16 weeks including 2-week Sorafenib run-in period prior to initiation of combination therapy
Results posted on
2023-11-15
Participant Flow
Participant milestones
| Measure |
Experimental Napabucasin+Sorafenib Phase IB Dose- Level 1
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 160 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Napabucasin+Sorafenib Phase IB Dose-Level 2
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 240 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib +Sorafenib Phase IB Dose- Level 1
Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib+Sorafenib Phase IB Dose-Level 2
Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Napabucasin+Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib+Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
4
|
9
|
28
|
10
|
31
|
|
Overall Study
COMPLETED
|
5
|
10
|
4
|
9
|
25
|
10
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
0
|
3
|
Reasons for withdrawal
| Measure |
Experimental Napabucasin+Sorafenib Phase IB Dose- Level 1
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 160 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Napabucasin+Sorafenib Phase IB Dose-Level 2
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin will be 240 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib +Sorafenib Phase IB Dose- Level 1
Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib+Sorafenib Phase IB Dose-Level 2
Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Napabucasin+Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib+Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Patients randomized but never treated
|
0
|
0
|
0
|
0
|
3
|
0
|
3
|
Baseline Characteristics
A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Experimental Napabucasin +Sorafenib Phase IB- Dose Level 1
n=5 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib.
The dose of Napabucasin will be 160 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Napabucasin +Sorafenib Phase IB- Dose Level 2
n=10 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib.
The dose of Napabucasin will be 240 mg twice daily Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib +Sorafenib Phase IB- Dose Level 1
n=4 Participants
Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
Experimental Amcasertib +Sorafenib Phase IB- Dose Level 2
n=9 Participants
Amcasertib will be administered orally daily in combination with sorafenib. The dose of Amcasertib to be administered will be 200mg once daily. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). This dose of sorafenib will be the same for each arm and for each dose-level cohort. Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Napabucasin +Sorafenib Phase II
n=28 Participants
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Experimental Amcasertib +Sorafenib Phase II
n=10 Participants
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
n=31 Participants
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 5.22 • n=99 Participants
|
70.8 years
STANDARD_DEVIATION 4.42 • n=107 Participants
|
55.0 years
STANDARD_DEVIATION 22.20 • n=206 Participants
|
60.6 years
STANDARD_DEVIATION 5.22 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 8.72 • n=31 Participants
|
68.4 years
STANDARD_DEVIATION 9.98 • n=30 Participants
|
67.7 years
STANDARD_DEVIATION 8.73 • n=3 Participants
|
65.7 years
STANDARD_DEVIATION 9.38 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
76 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
66 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 16 weeks including 2-week Sorafenib run-in period prior to initiation of combination therapyTo assess the dose limiting toxicities for phase IB
Outcome measures
| Measure |
Napabucasin+Sorafenib Phase IB- Dose Level 1
n=5 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Napabucasin+Sorafenib Phase IB- Dose Level 2
n=10 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+Sorafenib Phase IB- Dose Level 1
n=4 Participants
Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+ Sorafenib Phase IB Dose Level 2
n=9 Participants
Amcasertib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin Plus Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
Experimental Amcasertib Plus Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
|---|---|---|---|---|---|---|---|
|
Assessment of the Dose Limiting Toxicities for the Napabucasin and Amcasertib Arm in Combination With Sorafenib for Phase IB
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Adverse events will be assessed at baseline, while the participant is taking drugs, and for 30 days after stopping therapy. It was expected that patients would receive between 4-24 weeks treatment.Assessment of safety of either BBI608 or BBI503 given in combination with sorafenib to patients with hepatocellular carcinoma by reporting of adverse events and serious adverse events
Outcome measures
| Measure |
Napabucasin+Sorafenib Phase IB- Dose Level 1
n=5 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Napabucasin+Sorafenib Phase IB- Dose Level 2
n=10 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+Sorafenib Phase IB- Dose Level 1
n=4 Participants
Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+ Sorafenib Phase IB Dose Level 2
n=9 Participants
Amcasertib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin Plus Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
Experimental Amcasertib Plus Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
|---|---|---|---|---|---|---|---|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs
|
5 count of participants
|
10 count of participants
|
4 count of participants
|
9 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs CTCAE ≥Grade 3 TEAEs
|
3 count of participants
|
8 count of participants
|
3 count of participants
|
5 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with serious TEAEs
|
0 count of participants
|
3 count of participants
|
2 count of participants
|
5 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs leading to treatment discontinuation
|
0 count of participants
|
2 count of participants
|
2 count of participants
|
1 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs leading to Death
|
0 count of participants
|
0 count of participants
|
1 count of participants
|
1 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs leading to Napabucasin reduction
|
1 count of participants
|
3 count of participants
|
0 count of participants
|
0 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs leading to Amcasertib dose reduction
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs leading to Napabucasin dose held
|
1 count of participants
|
7 count of participants
|
0 count of participants
|
0 count of participants
|
—
|
—
|
—
|
|
To Assess the Number of Patients Who Experienced Adverse Events for Phase IB.
Patients with TEAEs leading to Amcasertib dose held
|
0 count of participants
|
0 count of participants
|
2 count of participants
|
6 count of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 16 weeks including 2-week Sorafenib run-in period prior to initiation of combination therapyTo determine the recommended phase II dose for Napabucasin and Amcasertib arm in combination with sorafenib
Outcome measures
| Measure |
Napabucasin+Sorafenib Phase IB- Dose Level 1
n=15 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Napabucasin+Sorafenib Phase IB- Dose Level 2
n=13 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+Sorafenib Phase IB- Dose Level 1
Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+ Sorafenib Phase IB Dose Level 2
Amcasertib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin Plus Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
Experimental Amcasertib Plus Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
|---|---|---|---|---|---|---|---|
|
Determination of the Recommended Phase II Dose for Napabucasin and Amcasertib Arm in Combination With Sorafenib
Recommended Dose of Napabucasin for phase II
|
480 mg
|
NA mg
The recommended dose for Napabucasin and Amcasertib has been evaluated by arm only for phase IB.
|
—
|
—
|
—
|
—
|
—
|
|
Determination of the Recommended Phase II Dose for Napabucasin and Amcasertib Arm in Combination With Sorafenib
Recommended dose of Amcasertib for Phase II
|
NA mg
The recommended dose for Napabucasin and Amcasertib has been evaluated by arm only for phase IB.
|
100 mg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessment of the preliminary anti-tumor activity by performing tumor assessments at baseline and every 8 weeks after the date of the first dose of protocol therapyTo evaluate the preliminary anti-tumor activity in patients with advanced hepatocellular carcinoma randomized to receive treatment with sorafenib in combination with Napabucasin or sorafenib in combination with Amcasertib, or sorafenib alone; Napabucasin and Amcasertib will be administered at their respective RP2D dose levels for combination administration with sorafenib, which were determined during the phase Ib portion of the study. The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST for patients with hepatocellular carcinoma. ORR was defined as the percentage of patients with a best overall response (BOR) of complete response (CR) or partial response (PR), using both RECIST and mRECIST assessment data.
Outcome measures
| Measure |
Napabucasin+Sorafenib Phase IB- Dose Level 1
n=28 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Napabucasin+Sorafenib Phase IB- Dose Level 2
n=10 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+Sorafenib Phase IB- Dose Level 1
n=31 Participants
Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+ Sorafenib Phase IB Dose Level 2
Amcasertib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin Plus Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
Experimental Amcasertib Plus Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
|---|---|---|---|---|---|---|---|
|
Assessment of Objective Response Rate in the Intent to Treat Population - Phase II
Assessment of Objective Response Rate based on RECIST 1.1 criteria
|
3.6 percentage of participants
Interval 0.1 to 18.3
|
0 percentage of participants
Interval 0.0 to 30.8
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
—
|
—
|
—
|
—
|
|
Assessment of Objective Response Rate in the Intent to Treat Population - Phase II
Assessment of Objective Response Rate based on mRECIST 1.1 criteria
|
3.6 percentage of participants
Interval 0.1 to 18.3
|
0 percentage of participants
Interval 0.0 to 30.8
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessment of the preliminary anti-tumor activity by performing tumor assessments at baseline and every 8 weeks after the date of the first dose of protocol therapyTo evaluate the preliminary anti-tumor activity in patients with advanced hepatocellular carcinoma randomized to receive treatment with sorafenib in combination with Napabucasin, sorafenib in combination with Amcasertib\*, or sorafenib alone; Napabucasin and Amcasertib will be administered at their respective RP2D dose levels for combination administration with sorafenib, which were determined during the phase Ib portion of the study. The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST for patients with hepatocellular carcinoma. Disease control rate (DCR), defined as the proportion of patients with best response of complete response (CR), Partial Response (PR), or stable disease (SD)
Outcome measures
| Measure |
Napabucasin+Sorafenib Phase IB- Dose Level 1
n=28 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 160 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Napabucasin+Sorafenib Phase IB- Dose Level 2
n=10 Participants
Napabucasin will be administered orally twice daily in combination with sorafenib. The dose of Napabucasin to be administered will be 240 mg twice daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Napabucasin in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+Sorafenib Phase IB- Dose Level 1
n=31 Participants
Amcasetib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib to be administered will be 100mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Amcasertib+ Sorafenib Phase IB Dose Level 2
Amcasertib will be administered orally once daily in combination with sorafenib. The dose of Amcasertib will be 200mg once daily. The patients are considered evaluable for the determination dose level toxicities and determination of dose escalation if they have been exposed to at least 28 days of continues daily administration of Amcasertib in combination with sorafenib at a compliance level of at least 80% Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin Plus Sorafenib Phase II
Phase II Napabucasin will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
Experimental Amcasertib Plus Sorafenib Phase II
Phase II Amcasertib will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
|
Sorafenib Phase II
Phase II Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug
|
|---|---|---|---|---|---|---|---|
|
Assessment of Disease Control Rate in the Intent to Treat Population- Phase II
Assessment of Objective Response Rate based on RECIST 1.1 criteria
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
48.4 percentage of participants
Interval 30.2 to 66.9
|
—
|
—
|
—
|
—
|
|
Assessment of Disease Control Rate in the Intent to Treat Population- Phase II
Assessment of Objective Response Rate based on mRECIST 1.1 criteria
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
48.4 percentage of participants
Interval 30.2 to 66.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Day 15 of the first cycle and Day 15 of the second cycle, prior to dosing and every one hours to 11 hours and 24 hours after first dosePopulation: PK parameters were not calculated for this study and are not available. The analyses were not performed as decisions were made to discontinue all clinical development of amcasertib, and of napabucasin for hepatocellular carcinoma.
To determine the pharmacokinetic (PK) profile of napabucasin administered in combination with sorafenib and of amcasertib administered in combination with sorafenib.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On day 15 of the second cyclePopulation: PD assessments were not performed for this study and are not available. Archival tissue, with raw staining scores, and no correlative analyses with clinical data were performed. Analyses were not performed as decisions were made to discontinue all clinical development of amcasertib, and also to discontinue development of napabucasin for hepatocellular carcinoma.
To perform biomarker studies for napabucasin administered in combination with sorafenib and for amcasertib administered in combination with sorafenib.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Napabucasin+Sorafenib Phase IB- Dose Level 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
Experimental Napabucasin +Sorafenib Phase IB- Dose Level 2
Serious events: 3 serious events
Other events: 10 other events
Deaths: 7 deaths
Experimental Amcasertib+Sorafenib Phase IB- Dose Level 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Experimental Amcasertib+Sorafenib Phase IB- Dose Level 2
Serious events: 5 serious events
Other events: 9 other events
Deaths: 9 deaths
Experimental Napabucasin +Sorafenib Phase II
Serious events: 10 serious events
Other events: 20 other events
Deaths: 15 deaths
Experimental Amcasertib +Sorafenib Phase II
Serious events: 3 serious events
Other events: 7 other events
Deaths: 6 deaths
Sorafenib Phase II
Serious events: 16 serious events
Other events: 35 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Experimental Napabucasin+Sorafenib Phase IB- Dose Level 1
n=5 participants at risk
Patients who have received at least one dose of Napabucasin in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin +Sorafenib Phase IB- Dose Level 2
n=10 participants at risk
Patients who have received at least one dose of Napabucasin in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Amcasertib+Sorafenib Phase IB- Dose Level 1
n=4 participants at risk
Patients who have received at least one dose of Amcasertib in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Amcasertib+Sorafenib Phase IB- Dose Level 2
n=9 participants at risk
Patients who have received at least one dose of Amcasertib in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin +Sorafenib Phase II
n=20 participants at risk
Phase II: Patients who have received at least one dose of Napabucasin (at the RP2D determined for napabucasin plus sorafenib during the Phase 1b portion) in combination with sorafenib. In the amcasertib + sorafenib arm, there were 10 patients randomized. Of these 10 patients, 3 discontinued during the Run-in period consisting of sorafenib monotherapy; therefore, the total to receive both amcasertib + sorafenib in Phase 2 was 7
|
Experimental Amcasertib +Sorafenib Phase II
n=7 participants at risk
Phase II: Patients who have received at least one dose of amcasertib (at the RP2D determined for amcasertib plus sorafenib during the Phase 1b portion) in combindation with sorafenib. There were 28 total randomized and 25 who received at least 1 dose of study treatment. Of these 25 patients, 5 discontinued during the Run-in period consisting of sorafenib monotherapy; therefore, the total number of patients to receive both napabucasin + sorafenib in Phase 2 was 20
|
Sorafenib Phase II
n=36 participants at risk
Phase II: Patients who have received at least one dose of sorafenib
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
33.3%
3/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
2/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
28.6%
2/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
8.3%
3/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.6%
2/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Esophageal varices
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Acute Focal Pancreatitis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.6%
2/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Gastointestinal Hemorrhage
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
2/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Meningitis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Infections and infestations
Urinary Track infection
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
General disorders
Asthenia generalized
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
15.0%
3/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Hepatobiliary disorders
Acute Cholecystitis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
2/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
14.3%
1/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.6%
2/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Injury, poisoning and procedural complications
spinal fracture
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Injury, poisoning and procedural complications
Hypoxia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Product Issues
Biliary tube displaced
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Product Issues
Bile Sten Occlusion
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
5.0%
1/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mature B-Cell Lymphoma
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
2.8%
1/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
Other adverse events
| Measure |
Experimental Napabucasin+Sorafenib Phase IB- Dose Level 1
n=5 participants at risk
Patients who have received at least one dose of Napabucasin in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin +Sorafenib Phase IB- Dose Level 2
n=10 participants at risk
Patients who have received at least one dose of Napabucasin in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Amcasertib+Sorafenib Phase IB- Dose Level 1
n=4 participants at risk
Patients who have received at least one dose of Amcasertib in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Amcasertib+Sorafenib Phase IB- Dose Level 2
n=9 participants at risk
Patients who have received at least one dose of Amcasertib in combination with sorafenib during the phase 1 dose-escalation portion of study. Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose).
|
Experimental Napabucasin +Sorafenib Phase II
n=20 participants at risk
Phase II: Patients who have received at least one dose of Napabucasin (at the RP2D determined for napabucasin plus sorafenib during the Phase 1b portion) in combination with sorafenib. In the amcasertib + sorafenib arm, there were 10 patients randomized. Of these 10 patients, 3 discontinued during the Run-in period consisting of sorafenib monotherapy; therefore, the total to receive both amcasertib + sorafenib in Phase 2 was 7
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Experimental Amcasertib +Sorafenib Phase II
n=7 participants at risk
Phase II: Patients who have received at least one dose of amcasertib (at the RP2D determined for amcasertib plus sorafenib during the Phase 1b portion) in combindation with sorafenib. There were 28 total randomized and 25 who received at least 1 dose of study treatment. Of these 25 patients, 5 discontinued during the Run-in period consisting of sorafenib monotherapy; therefore, the total number of patients to receive both napabucasin + sorafenib in Phase 2 was 20
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Sorafenib Phase II
n=36 participants at risk
Phase II: Patients who have received at least one dose of sorafenib
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|---|---|---|---|---|---|---|---|
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Gastrointestinal disorders
Diarrhea
|
80.0%
4/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
70.0%
7/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
75.0%
3/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
77.8%
7/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
85.0%
17/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
85.7%
6/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
18/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
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|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
5/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
2/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
55.6%
5/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
45.0%
9/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
42.9%
3/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
47.2%
17/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
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|
Gastrointestinal disorders
Abdominal pain
|
60.0%
3/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
30.0%
3/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
33.3%
3/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
10/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
42.9%
3/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
19.4%
7/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
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|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
2/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
5/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
57.1%
4/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
9/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
44.4%
4/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
4/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
28.6%
2/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
8/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
2/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
General disorders
Fatigue
|
80.0%
4/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
80.0%
8/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
66.7%
6/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
75.0%
15/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
85.7%
6/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
61.1%
22/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
General disorders
Asthenia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
5/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
40.0%
4/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
General disorders
Chills
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
40.0%
2/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrosaesthesia syndrome
|
40.0%
2/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
2/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
2/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
15.0%
3/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
42.9%
3/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
9/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
2/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
40.0%
4/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
50.0%
2/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
55.6%
5/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
40.0%
8/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
42.9%
3/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
44.4%
16/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
2/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
30.0%
3/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
40.0%
2/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
10.0%
1/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Investigations
Aspartate aminotrasnferase increased
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
30.0%
3/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
5/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
28.6%
2/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
16.7%
6/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Investigations
Weight Decreased
|
40.0%
2/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
33.3%
3/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
4/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
42.9%
3/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
38.9%
14/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
30.0%
3/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
30.0%
3/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
2/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
60.0%
3/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
11.1%
1/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
30.0%
3/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
1/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
2/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
25.0%
5/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
14.3%
1/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
22.2%
8/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/10 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/4 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
0.00%
0/9 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
20.0%
4/20 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
42.9%
3/7 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
19.4%
7/36 • From the date of the first treatment until 30 days of the last administration of the study drug for an average period of 28 weeks. The total period for both phase I and phase II of the study was 5 years.
Napabucasin+Sorafenib Phase II:There were 25 who received at least 1 dose.5 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both napabucasin + sorafenib was 20. Amcasertib+Sorafenib Phase II: There were 10 patients and 3 discontinued during the Run-inperiod consisting of sorafenib only;total to receive both amcasertib + sorafenib was 7.Sorafenib Phase II:Patients from napabucasin and amcasertib arms who only received sorafenib were analyzed with sorafenib arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of any proposed publication or disclosure of the results of the Study will be given to Sponsor for review at least thirty (30) days prior to the date of submission for publication ( including abstracts) or of public disclosure ( the review period).
- Publication restrictions are in place
Restriction type: OTHER