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Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01596751
Recruitment Status : Completed
First Posted : May 11, 2012
Results First Posted : May 14, 2020
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Plexxikon
Information provided by (Responsible Party):
Hope Rugo, MD, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: PLX3397
Drug: Eribulin
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/2: 800 mg/Day PLX3397 Lead In+Combined With Eribulin
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 5 4 3 6 4 6 17 22
Completed 5 4 3 6 4 6 17 22
Not Completed 0 0 0 0 0 0 0 0
Arm/Group Title Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 5 4 3 6 4 6 17 22 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 3 participants 6 participants 4 participants 6 participants 17 participants 22 participants 67 participants
50.79
(33.2 to 60.5)
54.38
(39.1 to 67.9)
41.88
(39.5 to 46.4)
51.30
(37.0 to 63.6)
46.46
(36.7 to 60.0)
48.33
(32.3 to 61.5)
54.31
(39.7 to 71.1)
56.06
(37.9 to 79.7)
51.54
(32.3 to 79.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 3 participants 6 participants 4 participants 6 participants 17 participants 22 participants 67 participants
Female
5
 100.0%
4
 100.0%
3
 100.0%
6
 100.0%
4
 100.0%
6
 100.0%
17
 100.0%
22
 100.0%
67
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 3 participants 6 participants 4 participants 6 participants 17 participants 22 participants 67 participants
Hispanic or Latino
1
  20.0%
0
   0.0%
0
   0.0%
3
  50.0%
0
   0.0%
0
   0.0%
1
   5.9%
2
   9.1%
7
  10.4%
Not Hispanic or Latino
4
  80.0%
3
  75.0%
3
 100.0%
3
  50.0%
4
 100.0%
6
 100.0%
14
  82.4%
18
  81.8%
55
  82.1%
Unknown or Not Reported
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.8%
2
   9.1%
5
   7.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 3 participants 6 participants 4 participants 6 participants 17 participants 22 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  20.0%
1
  25.0%
1
  33.3%
1
  16.7%
1
  25.0%
0
   0.0%
1
   5.9%
2
   9.1%
8
  11.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   4.5%
2
   3.0%
White
4
  80.0%
3
  75.0%
1
  33.3%
4
  66.7%
3
  75.0%
4
  66.7%
12
  70.6%
14
  63.6%
45
  67.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  33.3%
1
  16.7%
0
   0.0%
1
  16.7%
4
  23.5%
5
  22.7%
12
  17.9%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of PLX3397 Given in Combination With Standard Dose Eribulin in Participants With Metastatic Breast Cancer (Phase 1b)
Hide Description 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.
Time Frame Up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase Ib: Eribulin in Combination With PLX3397
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: miligrams per day
1,000
2.Primary Outcome
Title Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (Phase Ib)
Hide Description DLTs 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.
Time Frame Up to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 5 4 3 6 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
3.Primary Outcome
Title Percentage of Total Phase II Participants With Chemotherapy Pre-Treated Triple Negative Metastatic Breast Cancer Who Are Progression Free at 3 Months
Hide Description 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.
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Phase II: PLX3397 Combined With Eribulin
Hide Arm/Group Description:
Treatment began with a 7 day Lead-in Phase, consisting of 800 mg or 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 800 mg or 1000mg /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 Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
35.7
(21.5 to 59.4)
4.Secondary Outcome
Title Objective Response Rate (ORR) (Phase II)
Hide Description 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.
Time Frame From baseline until study completion, an average of 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Both Phase II Cohorts were combined for this planned analysis. Only 31 participants in Phase II obtained an objective event per RECIST v1.1
Arm/Group Title Phase II: PLX3397 Combined With Eribulin
Hide Arm/Group Description:
Treatment began with a 7 day Lead-in Phase, consisting of 800 mg or 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 800 mg or 1000mg /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 Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
16
5.Secondary Outcome
Title Median Duration of Response (Phase II)
Hide Description 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.
Time Frame From date of first confirmed disease response to confirmed disease progression or death due to any cause, an average of 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Both Phase II Cohorts were combined for this planned analysis. Only 5 participants in Phase II obtained an objective response
Arm/Group Title Phase II: PLX3397 Combined With Eribulin
Hide Arm/Group Description:
Treatment began with a 7 day Lead-in Phase, consisting of 800 mg or 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 800 mg or 1000mg /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 Number of Participants Analyzed 5
Median (Full Range)
Unit of Measure: days
94
(46 to 130)
6.Secondary Outcome
Title Median Time to Disease Progression (Phase II)
Hide Description 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
Time Frame From Day 1 to date of disease progression, an average of 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Phase II: PLX3397 Combined With Eribulin
Hide Arm/Group Description:
Treatment began with a 7 day Lead-in Phase, consisting of 800 mg or 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 800 mg or 1000mg /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 Number of Participants Analyzed 31
Median (Full Range)
Unit of Measure: days
50.2
(21 to 230)
Time Frame Up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
Hide Arm/Group Description

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

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

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

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

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

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

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

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
All-Cause Mortality
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      1/6 (16.67%)      0/4 (0.00%)      0/6 (0.00%)      1/17 (5.88%)      0/22 (0.00%)    
Hide Serious Adverse Events
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      3/4 (75.00%)      1/3 (33.33%)      2/6 (33.33%)      1/4 (25.00%)      3/6 (50.00%)      6/17 (35.29%)      14/22 (63.64%)    
Blood and lymphatic system disorders                 
Febrile neutropenia † 1  3/5 (60.00%)  3 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 5/22 (22.73%)  6
Cardiac disorders                 
Atrial fibrillation † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 0/22 (0.00%)  0
Myocardial Infarction † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Eye disorders                 
Blurred Vision † 1  0/5 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Gastrointestinal disorders                 
Dysphagia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
General disorders                 
Fever † 1  0/5 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 2/17 (11.76%)  2 1/22 (4.55%)  1
General disorders and administration site conditions - Other † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 2/22 (9.09%)  2
Localized edema † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Non-cardiac chest pain † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Pain † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations                 
Sepsis † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Catheter related infection † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0 0/22 (0.00%)  0
Soft Tissue infection † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Infections and Infestations other † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0 0/22 (0.00%)  0
Investigations                 
Alanine aminotransferase increased † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Aspartate aminotransferase increased † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 1/22 (4.55%)  1
Blood bilirubin increased † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 0/22 (0.00%)  0
Neutrophil count decreased † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Metabolism and nutrition disorders                 
Hyponatremia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 0/22 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Back Pain † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Bone Pain † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Nervous system disorders                 
Paresthesia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 0/22 (0.00%)  0
Transient Ischemia Attack † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Psychiatric disorders                 
Confusion † 1  0/5 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Dyspnea † 1  0/5 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 4/22 (18.18%)  4
Hoarseness † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Pleural effusion † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 1/17 (5.88%)  1 0/22 (0.00%)  0
Respiratory failure † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Hypoxia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0 0/22 (0.00%)  0
Cough † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders - Other † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders                 
Rash maculo-papular † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0 1/22 (4.55%)  1
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      4/4 (100.00%)      1/3 (33.33%)      4/6 (66.67%)      3/4 (75.00%)      6/6 (100.00%)      14/17 (82.35%)      22/22 (100.00%)    
Gastrointestinal disorders                 
Diarrhea † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/4 (25.00%)  1 2/6 (33.33%)  2 4/17 (23.53%)  5 7/22 (31.82%)  7
Mucositis oral † 1  2/5 (40.00%)  4 1/4 (25.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 2/4 (50.00%)  2 0/6 (0.00%)  0 3/17 (17.65%)  5 4/22 (18.18%)  4
Nausea † 1  1/5 (20.00%)  1 1/4 (25.00%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 4/6 (66.67%)  4 9/17 (52.94%)  11 8/22 (36.36%)  11
Vomiting † 1  2/5 (40.00%)  2 0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 1/17 (5.88%)  1 6/22 (27.27%)  13
Dyspepsia † 1  1/5 (20.00%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 2/22 (9.09%)  2
Bloating † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0 3/22 (13.64%)  3
Constipation † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1 0/17 (0.00%)  0 3/22 (13.64%)  3
Abdominal Pain † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 1/17 (5.88%)  1 1/22 (4.55%)  1
General disorders                 
Fatigue † 1  3/5 (60.00%)  4 2/4 (50.00%)  2 1/3 (33.33%)  1 2/6 (33.33%)  2 0/4 (0.00%)  0 2/6 (33.33%)  2 10/17 (58.82%)  13 14/22 (63.64%)  19
Fever † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 1/4 (25.00%)  1 2/6 (33.33%)  2 6/17 (35.29%)  7 5/22 (22.73%)  21
Pain † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 3/17 (17.65%)  3 6/22 (27.27%)  10
Hepatobiliary disorders                 
Hepatic Failure † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 0/22 (0.00%)  0
Infections and infestations                 
Upper respiratory infection † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  4 1/4 (25.00%)  1 1/6 (16.67%)  1 1/17 (5.88%)  2 0/22 (0.00%)  0
Investigations                 
Alanine aminotransferase increased † 1  0/5 (0.00%)  0 1/4 (25.00%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 3/4 (75.00%)  6 2/6 (33.33%)  2 7/17 (41.18%)  18 8/22 (36.36%)  24
Alkaline phosphatase increased † 1  0/5 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 2/17 (11.76%)  7 4/22 (18.18%)  4
Aspartate aminotransferase increased † 1  1/5 (20.00%)  1 1/4 (25.00%)  2 0/3 (0.00%)  0 2/6 (33.33%)  3 3/4 (75.00%)  7 2/6 (33.33%)  3 7/17 (41.18%)  20 10/22 (45.45%)  24
Blood bilirubin increased † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 2/22 (9.09%)  2
Neutrophil count decreased † 1  2/5 (40.00%)  5 1/4 (25.00%)  2 1/3 (33.33%)  1 0/6 (0.00%)  0 2/4 (50.00%)  5 1/6 (16.67%)  1 9/17 (52.94%)  23 7/22 (31.82%)  18
Platelet count decreased † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2 0/17 (0.00%)  0 2/22 (9.09%)  3
White blood cell decreased † 1  3/5 (60.00%)  5 1/4 (25.00%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 8/17 (47.06%)  12 2/22 (9.09%)  5
Metabolism and nutrition disorders                 
Anorexia † 1  3/5 (60.00%)  3 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/4 (50.00%)  2 4/6 (66.67%)  5 4/17 (23.53%)  5 3/22 (13.64%)  3
Hpyerglycemia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  3 2/22 (9.09%)  9
Hypokalemia † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1 3/17 (17.65%)  3 1/22 (4.55%)  1
Hypomagnesemia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 4/22 (18.18%)  7
Musculoskeletal and connective tissue disorders                 
Back Pain † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 2/17 (11.76%)  3 1/22 (4.55%)  1
Generalized muscle weakness † 1  2/5 (40.00%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 2/22 (9.09%)  3
Myalgia † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 2/22 (9.09%)  3
Nervous system disorders                 
Headache † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 6/22 (27.27%)  9
Peripheral sensory neuropathy † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 5/17 (29.41%)  5 5/22 (22.73%)  7
Dizziness † 1  1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2 1/22 (4.55%)  1
Dysgeusia † 1  0/5 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 2/22 (9.09%)  2
Psychiatric disorders                 
Anzxiety † 1  1/5 (20.00%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 2/22 (9.09%)  3
Insomnia † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1 4/22 (18.18%)  4
Respiratory, thoracic and mediastinal disorders                 
Cough † 1  0/5 (0.00%)  0 3/4 (75.00%)  4 0/3 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 6/17 (35.29%)  7 6/22 (27.27%)  6
Dyspnea † 1  2/5 (40.00%)  2 2/4 (50.00%)  3 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 5/17 (29.41%)  6 3/22 (13.64%)  7
Sore Throat † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 5/17 (29.41%)  5 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Pruritus † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  4 2/22 (9.09%)  2
Rash maculo-papular † 1  3/5 (60.00%)  4 1/4 (25.00%)  1 0/3 (0.00%)  0 3/6 (50.00%)  4 1/4 (25.00%)  3 1/6 (16.67%)  3 5/17 (29.41%)  12 7/22 (31.82%)  15
Alopecia † 1  2/5 (40.00%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0 2/22 (9.09%)  2
Vascular disorders                 
Hypertension † 1  0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  2 4/22 (18.18%)  6
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Hope Rugo, MD
Organization: University of California, San Francisco
Phone: (415) 353-7070
EMail: Hope.Rugo@ucsf.edu
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Responsible Party: Hope Rugo, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01596751    
Other Study ID Numbers: 12751
NCI-2015-01321 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Submitted: May 7, 2012
First Posted: May 11, 2012
Results First Submitted: April 1, 2020
Results First Posted: May 14, 2020
Last Update Posted: July 17, 2020