Trial Outcomes & Findings for Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer (NCT NCT01596751)
NCT ID: NCT01596751
Last Updated: 2020-07-17
Results Overview
The MTD was determined using a standard dose-escalation schema with 3 to 6 participants per cohort (3+3 design) for participants enrolled in Phase 1b. The starting dose level of PLX3397 was 600 mg/day and was raised in successive cohorts up to a dose of 1000 mg/day. Participants in each Phase Ib cohort were followed for dose limiting toxicities (DLTs) within the first 21 days of combination therapy and had to receive at least 14 days of PLX3397 and 2 doses of eribulin during the first cycle in order to be considered evaluable for DLT (unless the missed doses were due to a DLT). A toxicity was considered a DLT if it was treatment related and met specific requirements for type of toxicity and severity assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4. The MTD was defined as the lowest dose level at which 2 or more participants in a cohort experienced a DLT. The dose level just below the MTD was selected for Phase 2.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Up to Day 21
Results posted on
2020-07-17
Participant Flow
Participant milestones
| Measure |
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin
Treatment began with a 7 day Lead-in Phase, consisting of 1000 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 1000 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase II/2: 800 mg/Day PLX3397 Lead In+Combined With Eribulin
Treatment began with a 7 day Lead-in Phase, consisting of 800 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 800 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
3
|
6
|
4
|
6
|
17
|
22
|
|
Overall Study
COMPLETED
|
5
|
4
|
3
|
6
|
4
|
6
|
17
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin
n=5 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
n=4 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
n=3 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
n=6 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
n=4 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
n=6 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin
n=17 Participants
Treatment began with a 7 day Lead-in Phase, consisting of 1000 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 1000 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
n=22 Participants
Treatment began with a 7 day Lead-in Phase, consisting of 800 mg/day PLX3397 given by mouth for 5 days followed by 2 days of rest (no PLX3397). Then combination treatment was given in 21 day cycles. For each cycle, participants received 800 mg/day of PLX3397 by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest repeated weekly and Eribulin at 1.4 mg/m2 intravenously on days 1 and 8.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.79 years
n=5 Participants
|
54.38 years
n=7 Participants
|
41.88 years
n=5 Participants
|
51.30 years
n=4 Participants
|
46.46 years
n=21 Participants
|
48.33 years
n=8 Participants
|
54.31 years
n=8 Participants
|
56.06 years
n=24 Participants
|
51.54 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
67 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21The MTD was determined using a standard dose-escalation schema with 3 to 6 participants per cohort (3+3 design) for participants enrolled in Phase 1b. The starting dose level of PLX3397 was 600 mg/day and was raised in successive cohorts up to a dose of 1000 mg/day. Participants in each Phase Ib cohort were followed for dose limiting toxicities (DLTs) within the first 21 days of combination therapy and had to receive at least 14 days of PLX3397 and 2 doses of eribulin during the first cycle in order to be considered evaluable for DLT (unless the missed doses were due to a DLT). A toxicity was considered a DLT if it was treatment related and met specific requirements for type of toxicity and severity assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4. The MTD was defined as the lowest dose level at which 2 or more participants in a cohort experienced a DLT. The dose level just below the MTD was selected for Phase 2.
Outcome measures
| Measure |
Phase Ib: Eribulin in Combination With PLX3397
n=28 Participants
Phase Ib:
21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously, day 1 and 8
* Cohort 1: 600 mg/day
* Cohort 2: 800 mg/day
* Cohort 3: 1000 mg/day
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of PLX3397 Given in Combination With Standard Dose Eribulin in Participants With Metastatic Breast Cancer (Phase 1b)
|
1,000 miligrams per day
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 21DLTs are select treatment related toxicities described in the protocol that were Grade 3 or 4 in severity per CTCAE v4, occurring within the first 21 days of combination therapy for patients enrolled in Phase Ib (for example, Grade 3 thrombocytopenia with significant bleeding, Grade 4 neutropenia lasting more than 5 days, or any Grade 3 or higher non-hematologic toxicity other than alopecia unless clearly unrelated to treatment). Grade 3 and 4 toxicities are considered severe and may be life threatening. Participants had to receive at least 14 days of PLX3397 and 2 doses of eribulin during the first cycle in order to be considered evaluable for DLT (unless the missed doses were due to a DLT). A treatment delay of greater than 7 days for PLX3397 or inability to get two doses of eribulin in the first cycle due to toxicity that was unrelated to cancer worsening or other illness was considered a DLT.
Outcome measures
| Measure |
Phase Ib: Eribulin in Combination With PLX3397
n=5 Participants
Phase Ib:
21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously, day 1 and 8
* Cohort 1: 600 mg/day
* Cohort 2: 800 mg/day
* Cohort 3: 1000 mg/day
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
n=4 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
n=3 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
n=6 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
n=4 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
n=6 Participants
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (Phase Ib)
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Both Phase II Cohorts were combined for this planned analysis. Only 31 participants in Phase II obtained an objective progression event per RECIST v1.1 criteria at month 3
Progression-free survival (PFS) at 3 months is defined as the proportion of participants in the combined Phase II cohorts that are alive and progression-free 90 days after Study Day 1, from the first administration of PLX3397 with eribulin. Duration of PFS is defined as the time from Study Day 1 to the earlier of disease progression or death due to any cause. These analyses are designed to include only objective progression events per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. PFS will be estimated as a simple percentage based upon the results of the 3 month tumor assessment. Participants for whom this assessment is not performed will be included as failures, even if known to be alive at this time point. Confidence intervals will be provided.
Outcome measures
| Measure |
Phase Ib: Eribulin in Combination With PLX3397
n=31 Participants
Phase Ib:
21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously, day 1 and 8
* Cohort 1: 600 mg/day
* Cohort 2: 800 mg/day
* Cohort 3: 1000 mg/day
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|
|
Percentage of Total Phase II Participants With Chemotherapy Pre-Treated Triple Negative Metastatic Breast Cancer Who Are Progression Free at 3 Months
|
35.7 Percentage of Participants
Interval 21.5 to 59.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline until study completion, an average of 24 monthsPopulation: Both Phase II Cohorts were combined for this planned analysis. Only 31 participants in Phase II obtained an objective event per RECIST v1.1
The objective response rate (ORR) is defined as the proportion of patients for whom the best overall response at the time of data cutoff is confirmed complete response (CR) or confirmed partial response (PR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria. The analysis of ORR employed the Per Protocol population. Patients who did not have any post-baseline tumor assessments were counted as non-responders.
Outcome measures
| Measure |
Phase Ib: Eribulin in Combination With PLX3397
n=31 Participants
Phase Ib:
21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously, day 1 and 8
* Cohort 1: 600 mg/day
* Cohort 2: 800 mg/day
* Cohort 3: 1000 mg/day
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Phase II)
|
16 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first confirmed disease response to confirmed disease progression or death due to any cause, an average of 2 monthsPopulation: Both Phase II Cohorts were combined for this planned analysis. Only 5 participants in Phase II obtained an objective response
Duration of response is defined as the time from first documentation of objective response that is subsequently confirmed to progressive disease (PD) by the criteria or death due to any cause. Responders who have not been documented to have progressed or died at time of data cutoff will be right censored at the last available adequate tumor assessment. Median duration of response and its associated confidence interval will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase Ib: Eribulin in Combination With PLX3397
n=5 Participants
Phase Ib:
21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously, day 1 and 8
* Cohort 1: 600 mg/day
* Cohort 2: 800 mg/day
* Cohort 3: 1000 mg/day
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|
|
Median Duration of Response (Phase II)
|
94 days
Interval 46.0 to 130.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to date of disease progression, an average of 4 monthsPopulation: Both Phase II Cohorts were combined for this planned analysis. Only 31 participants in Phase II obtained an objective progression event per RECIST v1.1 criteria
Time to progression will be estimated using the Kaplan-Meier method. Efficacy responses, disease progression and relapse classified based on RECIST v1.1 criteria will be used to determine progression. Time to progression will be calculated from the first administration of PLX3397 with eribulin. Participants who do not have disease progression will be censored at the date of the last evaluation for study disease or at the time of initiation of the new therapy, whichever is earlier. Patients lacking any response assessment after randomization will be censored at Day 1
Outcome measures
| Measure |
Phase Ib: Eribulin in Combination With PLX3397
n=31 Participants
Phase Ib:
21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously, day 1 and 8
* Cohort 1: 600 mg/day
* Cohort 2: 800 mg/day
* Cohort 3: 1000 mg/day
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 400 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.1 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 600 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 800 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Treatments were given in 21 day Cycles. For each cycle, participants received 1000 mg/day of PLX3397 in 100-200 mg gelcaps, by mouth daily \& Eribulin 1.4 mg/m2 intravenously on days 1 and 8.
|
|---|---|---|---|---|---|---|
|
Median Time to Disease Progression (Phase II)
|
50.2 days
Interval 21.0 to 230.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin
Serious events: 6 serious events
Other events: 14 other events
Deaths: 1 deaths
Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
Serious events: 14 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin
n=5 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 600 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 600mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
n=4 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 400 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 400mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
n=3 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 600 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 600 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
n=6 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 800 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
n=4 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 800 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
n=6 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 1000 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 1000 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin
n=17 participants at risk
Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.
Lead-in phase treatment:
* PLX3397 at a dose of 1000 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.
Treatment given in each 21 day cycle:
* PLX3397 at a dose of 1000 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 1000 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
n=22 participants at risk
Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.
Lead-in phase treatment:
* PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.
Treatment given in each 21 day cycle:
* PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
60.0%
3/5 • Number of events 3 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
22.7%
5/22 • Number of events 6 • Up to 24 months
|
|
General disorders
Fever
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
11.8%
2/17 • Number of events 2 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
33.3%
1/3 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
9.1%
2/22 • Number of events 2 • Up to 24 months
|
|
General disorders
Localized edema
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 2 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
18.2%
4/22 • Number of events 4 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Infections and infestations
Soft Tissue infection
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Infections and infestations
Infections and Infestations other
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
33.3%
1/3 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Nervous system disorders
Transient Ischemia Attack
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Eye disorders
Blurred Vision
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
Other adverse events
| Measure |
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin
n=5 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 600 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 600mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin
n=4 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 400 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 400mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin
n=3 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 600 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8.
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 600 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin
n=6 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 800 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin
n=4 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 800 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
n=6 participants at risk
Treatments are given in 21 day cycles. For each cycle, treatment includes:
* PLX3397 at a dose of 1000 mg/day taken by mouth in the form of 100-200 mg gelcaps
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 1000 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin
n=17 participants at risk
Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.
Lead-in phase treatment:
* PLX3397 at a dose of 1000 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.
Treatment given in each 21 day cycle:
* PLX3397 at a dose of 1000 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 1000 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
n=22 participants at risk
Treatment begins with a 7 day Lead-in phase of PLX3397 alone, followed by 21 day cycles of PLX3397 in combination with eribulin.
Lead-in phase treatment:
* PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest.
Treatment given in each 21 day cycle:
* PLX3397 at a dose of 800 mg/day given by mouth in the form of 100-200 mg gelcaps for 5 days followed by 2 days of rest, repeated weekly
* Eribulin at dose of 1.4 mg/m2 given intravenously on days 1 and 8
PLX3397: Dosage Form: 100 mg or 200 mg capsules, Dosage: 800 mg, oral administration
Eribulin: Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
9.1%
2/22 • Number of events 2 • Up to 24 months
|
|
Gastrointestinal disorders
Bloating
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
13.6%
3/22 • Number of events 3 • Up to 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
29.4%
5/17 • Number of events 5 • Up to 24 months
|
22.7%
5/22 • Number of events 7 • Up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
13.6%
3/22 • Number of events 3 • Up to 24 months
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 4 • Up to 24 months
|
50.0%
2/4 • Number of events 2 • Up to 24 months
|
33.3%
1/3 • Number of events 1 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
58.8%
10/17 • Number of events 13 • Up to 24 months
|
63.6%
14/22 • Number of events 19 • Up to 24 months
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
35.3%
6/17 • Number of events 7 • Up to 24 months
|
22.7%
5/22 • Number of events 21 • Up to 24 months
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
17.6%
3/17 • Number of events 3 • Up to 24 months
|
27.3%
6/22 • Number of events 10 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
11.8%
2/17 • Number of events 4 • Up to 24 months
|
9.1%
2/22 • Number of events 2 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
60.0%
3/5 • Number of events 4 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
50.0%
3/6 • Number of events 4 • Up to 24 months
|
25.0%
1/4 • Number of events 3 • Up to 24 months
|
16.7%
1/6 • Number of events 3 • Up to 24 months
|
29.4%
5/17 • Number of events 12 • Up to 24 months
|
31.8%
7/22 • Number of events 15 • Up to 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
3/5 • Number of events 3 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
50.0%
2/4 • Number of events 2 • Up to 24 months
|
66.7%
4/6 • Number of events 5 • Up to 24 months
|
23.5%
4/17 • Number of events 5 • Up to 24 months
|
13.6%
3/22 • Number of events 3 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hpyerglycemia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
11.8%
2/17 • Number of events 3 • Up to 24 months
|
9.1%
2/22 • Number of events 9 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
17.6%
3/17 • Number of events 3 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
18.2%
4/22 • Number of events 7 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 24 months
|
75.0%
3/4 • Number of events 4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
35.3%
6/17 • Number of events 7 • Up to 24 months
|
27.3%
6/22 • Number of events 6 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • Number of events 2 • Up to 24 months
|
50.0%
2/4 • Number of events 3 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
29.4%
5/17 • Number of events 6 • Up to 24 months
|
13.6%
3/22 • Number of events 7 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
29.4%
5/17 • Number of events 5 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
27.3%
6/22 • Number of events 9 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
40.0%
2/5 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
9.1%
2/22 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
9.1%
2/22 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
11.8%
2/17 • Number of events 3 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 4 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
5.9%
1/17 • Number of events 2 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 2 • Up to 24 months
|
18.2%
4/22 • Number of events 6 • Up to 24 months
|
|
Psychiatric disorders
Anzxiety
|
20.0%
1/5 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
9.1%
2/22 • Number of events 3 • Up to 24 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
18.2%
4/22 • Number of events 4 • Up to 24 months
|
|
Hepatobiliary disorders
Hepatic Failure
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
0.00%
0/22 • Up to 24 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
2/5 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
9.1%
2/22 • Number of events 2 • Up to 24 months
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
11.8%
2/17 • Number of events 2 • Up to 24 months
|
4.5%
1/22 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 2 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
33.3%
1/3 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
27.3%
6/22 • Number of events 13 • Up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 3 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
75.0%
3/4 • Number of events 6 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
41.2%
7/17 • Number of events 18 • Up to 24 months
|
36.4%
8/22 • Number of events 24 • Up to 24 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
11.8%
2/17 • Number of events 7 • Up to 24 months
|
18.2%
4/22 • Number of events 4 • Up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
25.0%
1/4 • Number of events 2 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
33.3%
2/6 • Number of events 3 • Up to 24 months
|
75.0%
3/4 • Number of events 7 • Up to 24 months
|
33.3%
2/6 • Number of events 3 • Up to 24 months
|
41.2%
7/17 • Number of events 20 • Up to 24 months
|
45.5%
10/22 • Number of events 24 • Up to 24 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
9.1%
2/22 • Number of events 2 • Up to 24 months
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • Number of events 5 • Up to 24 months
|
25.0%
1/4 • Number of events 2 • Up to 24 months
|
33.3%
1/3 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
50.0%
2/4 • Number of events 5 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
52.9%
9/17 • Number of events 23 • Up to 24 months
|
31.8%
7/22 • Number of events 18 • Up to 24 months
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
16.7%
1/6 • Number of events 2 • Up to 24 months
|
0.00%
0/17 • Up to 24 months
|
9.1%
2/22 • Number of events 3 • Up to 24 months
|
|
Investigations
White blood cell decreased
|
60.0%
3/5 • Number of events 5 • Up to 24 months
|
25.0%
1/4 • Number of events 2 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
47.1%
8/17 • Number of events 12 • Up to 24 months
|
9.1%
2/22 • Number of events 5 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
16.7%
1/6 • Number of events 1 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
33.3%
2/6 • Number of events 2 • Up to 24 months
|
23.5%
4/17 • Number of events 5 • Up to 24 months
|
31.8%
7/22 • Number of events 7 • Up to 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
2/5 • Number of events 4 • Up to 24 months
|
25.0%
1/4 • Number of events 2 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
50.0%
2/4 • Number of events 2 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
17.6%
3/17 • Number of events 5 • Up to 24 months
|
18.2%
4/22 • Number of events 4 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
33.3%
1/3 • Number of events 1 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
66.7%
4/6 • Number of events 4 • Up to 24 months
|
52.9%
9/17 • Number of events 11 • Up to 24 months
|
36.4%
8/22 • Number of events 11 • Up to 24 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Up to 24 months
|
25.0%
1/4 • Number of events 1 • Up to 24 months
|
0.00%
0/3 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
0.00%
0/4 • Up to 24 months
|
0.00%
0/6 • Up to 24 months
|
5.9%
1/17 • Number of events 1 • Up to 24 months
|
9.1%
2/22 • Number of events 2 • Up to 24 months
|
Additional Information
Dr. Hope Rugo, MD
University of California, San Francisco
Phone: (415) 353-7070
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place