Trial Outcomes & Findings for Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer (NCT NCT02562898)
NCT ID: NCT02562898
Last Updated: 2021-05-06
Results Overview
DLTs will be based on the first course of treatment and defined as any unexpected grade 3 non-hematologic toxicity not reversible to grade 2 or less within 96 hours, or any grade 4 toxicity. Grade 4 hematological toxicities will not be considered dose limiting in this trial since a significant fraction of patients who are treated with gemcitabine and nab-paclitaxel are expected to experience these toxicities. Grade 3 peripheral neuropathy, a common and expected toxicity of treatment with nabpaclitaxel, will not be considered a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2021-05-06
Participant Flow
Participant milestones
| Measure |
Dose Escalation for Safety and Toxicity
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
|
Immune Response Cohort
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Dose Escalation for Safety and Toxicity
n=10 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
|
Immune Response Cohort
n=8 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsDLTs will be based on the first course of treatment and defined as any unexpected grade 3 non-hematologic toxicity not reversible to grade 2 or less within 96 hours, or any grade 4 toxicity. Grade 4 hematological toxicities will not be considered dose limiting in this trial since a significant fraction of patients who are treated with gemcitabine and nab-paclitaxel are expected to experience these toxicities. Grade 3 peripheral neuropathy, a common and expected toxicity of treatment with nabpaclitaxel, will not be considered a DLT.
Outcome measures
| Measure |
Dose Escalation for Safety and Toxicity
n=10 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
Immune Response Cohort
n=8 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
|---|---|---|
|
Number of Patients Who Experienced a Dose-Limiting Toxicity (DLT)
|
9 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe dose level at which fewer than 2 of 6 patients experience a dose-limiting toxicity (DLT) will be designated as the Maximum Tolerated Dose (MTD)
Outcome measures
| Measure |
Dose Escalation for Safety and Toxicity
n=10 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
Immune Response Cohort
n=8 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
820 mg/day
|
560 mg/day
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Some patients did not have a decrease of 75% or did not have subsequent CA19-9 labs collected on study (i.e. off study prior to next time point) so they were not included in this analysis
The CA19-9 Response Rate is calculated using CA 19-9 treated patients who had a baseline CA19-9 \> 75 units who have confirmed CA19-9 reduction of 75% from baseline value. Patients who have missing CA19-9 measurements will be treated as non-responders, i.e., they will be included in the denominator when calculating the percentage. The CA19-9 Response Rate, along with exact 95% confidence intervals, will be reported for the study.
Outcome measures
| Measure |
Dose Escalation for Safety and Toxicity
n=6 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
Immune Response Cohort
n=7 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
|---|---|---|
|
CA19-9 Clinical Response Rate
|
0.333 proportion of responders
Interval 0.0433 to 0.7772
|
0.143 proportion of responders
Interval 0.0036 to 0.5787
|
SECONDARY outcome
Timeframe: 10 monthsTime to Progression is defined as the time from date of first dose of protocol therapy to time of documented radiographic and/or clinical disease progression or death from any cause. Kaplan-Meier methods will be used to summarize median TTP with 95% confidence intervals.
Outcome measures
| Measure |
Dose Escalation for Safety and Toxicity
n=10 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
Immune Response Cohort
n=8 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
|---|---|---|
|
Median Time-to-progression (TTP)
|
128 days
Interval 56.0 to
The upper range of the confidence interval was calculated to be infinity
|
126 days
Interval 64.0 to
The upper range of the confidence interval was calculated to be infinity
|
SECONDARY outcome
Timeframe: Up to 2 yearsMedian OS for all enrolled patients will be calculated from date of first dose of protocol therapy until date of death, using chart review and/or follow up phone calls to determine date of death in patients after removal from study. The survival of patients still alive after 2 years of follow up post study discontinuation will be censored. Alive patients are censored at the date last known alive. Kaplan-Meier methods will be used to summarize median OS with 95% confidence intervals.
Outcome measures
| Measure |
Dose Escalation for Safety and Toxicity
n=10 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
Immune Response Cohort
n=8 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
|---|---|---|
|
Median Overall Survival (OS)
|
246 days
Interval 84.0 to
The upper range of the confidence interval was calculated to be infinity
|
170 days
Interval 66.0 to
The upper range of the confidence interval was calculated to be infinity
|
SECONDARY outcome
Timeframe: 10 monthsPFS is defined as the duration of time from date of first dose of protocol therapy to time of documented radiographic and/or clinical disease progression or death from any cause. Eligible patients are evaluable for PFS who are response-evaluable and who are removed from study for radiographic or clinical progression and/or who experience death from any cause during study follow up. Patients who have not progressed or died are censored at the date last known to be progression-free. Kaplan-Meier methods will be used to summarize median PFS with 95% confidence intervals. The proportion of patients with PFS equal to or exceeding 6 months will also be calculated and reported along with 95% confidence intervals.
Outcome measures
| Measure |
Dose Escalation for Safety and Toxicity
n=10 Participants
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
Immune Response Cohort
n=8 Participants
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
Ibrutinib: 560, 840, 420, or 280mg, orally once per day - 4 week cycle
Paclitaxel: 125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
Gemcitabine: 1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
|
|---|---|---|
|
Median Progression-free Survival (PFS)
|
128 days
Interval 56.0 to
The upper range of the confidence interval was calculated to be infinity
|
99 days
Interval 64.0 to
The upper range of the confidence interval was calculated to be infinity
|
Adverse Events
Dose Escalation for Safety and Toxicity
Serious events: 5 serious events
Other events: 10 other events
Deaths: 10 deaths
Immune Response Cohort
Serious events: 3 serious events
Other events: 6 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Dose Escalation for Safety and Toxicity
n=10 participants at risk
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
|
Immune Response Cohort
n=8 participants at risk
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
GI Bleed
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Investigations
Blood Bilirubin increased
|
20.0%
2/10 • Number of events 3 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Investigations
Aspartate Aminotransferase
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
Other adverse events
| Measure |
Dose Escalation for Safety and Toxicity
n=10 participants at risk
All patients in phase Ib dosing escalation with extended safety and toxicity cohorts will start treatment with daily dosing of ibrutinib concurrently with standard doses of gemcitabine and nab-paclitaxel. Ibrutinib (560 mg/day, 840 mg/day, or 420 and 280 mg/day if de-escalation is necessary) will be started on day 1. Approximately patients 15-30 will be enrolled in escalation and extended safety cohort.
|
Immune Response Cohort
n=8 participants at risk
Subjects who are assigned to the Immune Response Cohort will have a biopsy before starting ibrutinib-only therapy. They will then receive ibrutinib for 7 days and have a second biopsy after completing the ibrutinib-only therapy, before starting the combination of chemotherapy with ibrutinib. Approximately 20 patients will be enrolled in this arm.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • Number of events 12 • Up to 2 years
|
62.5%
5/8 • Number of events 12 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
5/10 • Number of events 13 • Up to 2 years
|
62.5%
5/8 • Number of events 8 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 4 • Up to 2 years
|
37.5%
3/8 • Number of events 8 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
5/10 • Number of events 6 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
40.0%
4/10 • Number of events 4 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Number of events 5 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 17 • Up to 2 years
|
37.5%
3/8 • Number of events 5 • Up to 2 years
|
|
General disorders
Edema limbs
|
70.0%
7/10 • Number of events 12 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
General disorders
Fever
|
30.0%
3/10 • Number of events 4 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
60.0%
6/10 • Number of events 17 • Up to 2 years
|
25.0%
2/8 • Number of events 6 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
20.0%
2/10 • Number of events 3 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Investigations
Weight loss
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • Number of events 3 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • Number of events 6 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
50.0%
4/8 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
70.0%
7/10 • Number of events 7 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
4/10 • Number of events 5 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
3/10 • Number of events 4 • Up to 2 years
|
37.5%
3/8 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
4/10 • Number of events 4 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
2/10 • Number of events 3 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
70.0%
7/10 • Number of events 21 • Up to 2 years
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
40.0%
4/10 • Number of events 5 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
20.0%
2/10 • Number of events 4 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10 • Number of events 9 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
30.0%
3/10 • Number of events 3 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Esophageal pain
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Obstruction gastric
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
General disorders
Flu like symptoms
|
10.0%
1/10 • Number of events 2 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema Face
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
General disorders
Facial Pain
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
General disorders
Irritability
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Investigations
Creatinine increased
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
|
Reproductive system and breast disorders
Nasal congestion
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 3 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
10.0%
1/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
10.0%
1/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Infections and infestations
Paronychia
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Up to 2 years
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
12.5%
1/8 • Number of events 3 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Immune system disorders
Allergic reaction
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Eye disorders
Blurred Vision
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
0.00%
0/8 • Up to 2 years
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/10 • Up to 2 years
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
Additional Information
Dr. Margaret Tempero
University of California, San Francisco
Phone: 415-353-7528
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place