Trial Outcomes & Findings for STA-9090(Ganetespib) in Metastatic Ocular Melanoma (NCT NCT01200238)
NCT ID: NCT01200238
Last Updated: 2018-10-18
Results Overview
4-month PFS rate was defined as the proportion of participants alive, absent progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) and on treatment at 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Relevant for this endpoint was status at 4 months.
Results posted on
2018-10-18
Participant Flow
The first and last participants registered to cohort A on September 17, 2010 and June 6, 2011 and to cohort B on December 27, 2011 and May 12, 2014.
Participant milestones
| Measure |
STA-9090: Cohort A
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
STA-9090: Cohort A
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Progressive Disease
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
STA-9090(Ganetespib) in Metastatic Ocular Melanoma
Baseline characteristics by cohort
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
58.5 years
STANDARD_DEVIATION 18.4 • n=107 Participants
|
58.0 years
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Relevant for this endpoint was status at 4 months.Population: The analysis dataset is comprised of all enrolled participants.
4-month PFS rate was defined as the proportion of participants alive, absent progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) and on treatment at 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
4-month Progression Free Survival (PFS) Rate
|
0.059 proportion of participants
Interval 0.003 to 0.25
|
0.118 proportion of participants
Interval 0.021 to 0.326
|
PRIMARY outcome
Timeframe: Estimated up to 24 hours after administration of STA-9090Population: There was a problem with the assay and therefore this endpoint was not measured.
To estimate the proportion of patients with greater than 50% decrease in expression of HSP90 client protein c-MET 18-24 hours after administration of STA-9090
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)]. Thus, response on treatment was evaluated up to 31.7 months.Population: The analysis dataset is comprised of all enrolled participants.
ORR is defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
0.0 proportion of participants
Interval 0.0 to 0.348
|
0.10 proportion of participants
Interval 0.005 to 0.394
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)].Thus, response on treatment was evaluated up to 31.7 months.Population: The analysis dataset is comprised of all enrolled participants.
DCR is defined as achieving stable disease (SD), partial response (P R) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. PR or better response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
0.286 proportion of participants
Interval 0.054 to 0.659
|
0.30 proportion of participants
Interval 0.087 to 0.607
|
SECONDARY outcome
Timeframe: Dz was evaluated every 8 weeks on treatment; Imaging was obtained as clinically indicated until off-study; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months). Thus, follow-up was up to 36.4m.Population: The analysis dataset is comprised of all enrolled participants.
PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not experience progression were censored at date of last disease evaluation.
Outcome measures
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
1.6 months
Interval 0.8 to 3.5
|
1.8 months
Interval 0.9 to 7.1
|
SECONDARY outcome
Timeframe: Survival follow-up occurred every 4 weeks long-term; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months).Thus, follow-up was up to 36.4m.Population: The analysis dataset is comprised of all enrolled participants.
OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Overall Survival (OS)
|
8.5 months
Interval 3.7 to 28.7
|
4.9 months
Interval 3.2 to 13.0
|
SECONDARY outcome
Timeframe: AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)). Thus, AEs on treatment were followed up to 31.7 months.Population: The analysis dataset is comprised of all enrolled participants.
All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.
Outcome measures
| Measure |
STA-9090: Cohort A
n=7 Participants
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 Participants
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Grade 3-4 Treatment-Related Toxicity Rate
|
0.143 proportion of participants
Interval 0.007 to 0.521
|
0.80 proportion of participants
Interval 0.493 to 0.963
|
Adverse Events
STA-9090: Cohort A
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
STA-9090: Cohort B
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STA-9090: Cohort A
n=7 participants at risk
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 participants at risk
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Fatigue
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
40.0%
4/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
40.0%
4/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
GGT increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Lipase increased
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Weight loss
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
Other adverse events
| Measure |
STA-9090: Cohort A
n=7 participants at risk
Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090: Cohort B
n=10 participants at risk
Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).
Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Eye disorders
Floaters
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
40.0%
4/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
40.0%
4/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
90.0%
9/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Ileal fistula
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
70.0%
7/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
60.0%
6/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Chills
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Edema limbs
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Fatigue
|
57.1%
4/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
70.0%
7/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Fever
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Infusion related reaction
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Injection site reaction
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
General disorders
Pain
|
57.1%
4/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Immune system disorders
Allergic reaction
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Infections and infestations
Abdominal infection
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
50.0%
5/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
50.0%
5/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
50.0%
5/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
CPK increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Serum amylase increased
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
Weight loss
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
50.0%
5/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Investigations
White blood cell decreased
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
90.0%
9/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
40.0%
4/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
50.0%
5/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
40.0%
4/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Psychiatric disorders
Suicidal ideation
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
3/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
30.0%
3/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
20.0%
2/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
10.0%
1/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
14.3%
1/7 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
0.00%
0/10 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment; AEs were assessed for the median treatment duration of 1.8 months for each cohort and up to 12.5m in Cohort A and up to 31.7m in Cohort B and then add the 30 days post-treatment.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as grade 3 or higher events with any treatment-attribution. Other AEs were defined as grade 1 or 2 events with any treatment-attribution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place