Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01321 | Registry Identifier | NCI Clinical Trials Reporting Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
| Plexxikon | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397 when given in combination with standard dose eribulin (Halavenâ„¢). The purpose of the Phase 2 portion of the study is to find out what effects, good and/or bad, these drugs have on patients and their metastatic breast cancer.
This is a nonrandomized, open label phase Ib/II study evaluating the safety and efficacy of eribulin in combination with PLX3397, a novel CSF1 inhibitor, in patients with metastatic breast cancer. The phase II portion of this trial will be limited to patients with triple negative disease.
The phase I portion of this trial is a dose escalation of PLX3397 to determine the maximum tolerated dose (MTD) of PLX3397 when given in combination with standard dose eribulin. Patients will be enrolled in cohorts of three, using the dose levels and plan outlined in the statistical section, with 6 patients enrolled at the MTD. All patients with accessible tumor will be required to have a tumor biopsy at study start before starting therapy. Pharmacokinetics of PLX3397 and eribulin, and blood levels of CSF1 will be obtained as outlined in section 14. To allow rapid accrual to phase Ib, and an earlier start to the phase II trial, patients will be enrolled in phase I with both hormone receptor positive and negative disease, and at any line of therapy assuming eligibility criteria are otherwise met.
Dose limiting toxicity (DLT) will be defined as any treatment-related toxicity meeting the criteria below and occurring within the first 21 days of combination therapy. Patients must 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 are due to a DLT).
Patients in each cohort will be followed for at least 3 weeks (one full cycle) before opening accrual to the next dose level. If one patient in any cohort develops a DLT, an additional 3 patients will be enrolled at that level. If no additional toxicities occur in the six patients, then this particular dose would be used for the phase II trial, and the next higher dose would be considered the MTD. A minimum of 12 and maximum of 24 patients will be enrolled in the phase I study. The phase II trial will not open until the last patient in the phase I study has been followed for at least 3 weeks.
The phase II portion of this trial will evaluate progression free survival (PFS) in patients with Triple negative breast cancer (TNBC) treated with PLX3397 and eribulin, using the dose of PLX3397 determined in the phase Ib study in a two-step design. Please see the statistical section for details regarding enrollment and statistical design. Treatment is preceded by a 5 to 7 day lead-in phase, in which patients will take PLX3397 alone daily. Patients with accessible tumor will undergo a core biopsy of tumor before the start of PLX3397 treatment, and then a fine needle aspiration or core biopsy will be performed on the day of or the day before the start of eribulin (day -1 to day 0).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib: 600 mg/Day PLX3397 Combined with Eribulin | Experimental | Treatments are given in 21 day cycles. For each cycle, treatment includes:
|
|
| Phase Ib: 800 mg/Day PLX3397 Combined with Eribulin | Experimental | Treatments are given in 21 day cycles. For each cycle, treatment includes:
|
|
| Phase Ib: 1000 mg/Day PLX3397 Combined with Eribulin | Experimental | Treatments are given in 21 day cycles. For each cycle, treatment includes:
|
|
| Phase II: 800 mg/Day PLX3397 Lead in +Combined with Eribulin | Experimental | 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:
Treatment given in each 21 day cycle:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLX3397 | Drug | Dosage Form: 100 mg or 200 mg capsules, Dosage: 400 - 1000 mg, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of PLX3397 Given in Combination With Standard Dose Eribulin in Participants With Metastatic Breast Cancer (Phase 1b) | 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. | Up to Day 21 |
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (Phase Ib) | 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. | Up to Day 21 |
| Percentage of Total Phase II Participants With Chemotherapy Pre-Treated Triple Negative Metastatic Breast Cancer Who Are Progression Free at 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Phase II) | 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hope S. Rugo, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Duke University Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of PLX3397 Given in Combination With Standard Dose Eribulin in Participants With Metastatic Breast Cancer (Phase 1b) | 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. | Posted | Number | miligrams per day | Up to Day 21 |
|
Up to 24 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase Ib/1: 600 mg/Day PLX3397 Combined With Eribulin | Treatments are given in 21 day cycles. For each cycle, treatment includes:
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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hope Rugo, MD | University of California, San Francisco | (415) 353-7070 | Hope.Rugo@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2016 | Aug 1, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2016 | Nov 8, 2019 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000600259 | pexidartinib |
| C490954 | eribulin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Eribulin | Drug | 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 |
|
|
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.
| Up to 3 months |
| From baseline until study completion, an average of 24 months |
| Median Duration of Response (Phase II) | 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. | From date of first confirmed disease response to confirmed disease progression or death due to any cause, an average of 2 months |
| Median Time to Disease Progression (Phase II) | 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 | From Day 1 to date of disease progression, an average of 4 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | Phase II/2: 800 mg/Day PLX3397 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. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Phase Ib: Eribulin in Combination With PLX3397 | Phase Ib: 21 day treatment cycle: PLX3397 100-200 mg gelcaps, by mouth daily & Eribulin 1.4 mg/m2 intravenously, day 1 and 8
|
|
|
| Primary | Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (Phase Ib) | 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. | Posted | Count of Participants | Participants | Up to Day 21 |
|
|
|
| Primary | Percentage of Total Phase II Participants With Chemotherapy Pre-Treated Triple Negative Metastatic Breast Cancer Who Are Progression Free at 3 Months | 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. | 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 | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 3 months |
|
|
|
| Secondary | Objective Response Rate (ORR) (Phase II) | 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. | Both Phase II Cohorts were combined for this planned analysis. Only 31 participants in Phase II obtained an objective event per RECIST v1.1 | Posted | Number | percentage of participants | From baseline until study completion, an average of 24 months |
|
|
|
| Secondary | Median Duration of Response (Phase II) | 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. | Both Phase II Cohorts were combined for this planned analysis. Only 5 participants in Phase II obtained an objective response | Posted | Median | Full Range | days | From date of first confirmed disease response to confirmed disease progression or death due to any cause, an average of 2 months |
|
|
|
| Secondary | Median Time to Disease Progression (Phase II) | 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 | 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 | Posted | Median | Full Range | days | From Day 1 to date of disease progression, an average of 4 months |
|
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| 5 |
| 5 |
| EG001 | Phase Ib/2: 400 mg/Day PLX3397 Combined With Eribulin | Treatments are given in 21 day cycles. For each cycle, treatment includes:
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 | 0 | 4 | 3 | 4 | 4 | 4 |
| EG002 | Phase Ib/3: 600 mg/Day PLX3397 Combined With Eribulin | Treatments are given in 21 day cycles. For each cycle, treatment includes:
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 | 0 | 3 | 1 | 3 | 1 | 3 |
| EG003 | Phase Ib/4: 800 mg/Day PLX3397 Combined With Eribulin | Treatments are given in 21 day cycles. For each cycle, treatment includes:
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 | 1 | 6 | 2 | 6 | 4 | 6 |
| EG004 | Phase Ib/5: 800 mg/Day PLX3397 Combined With Eribulin | Treatments are given in 21 day cycles. For each cycle, treatment includes:
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 | 0 | 4 | 1 | 4 | 3 | 4 |
| EG005 | Phase Ib/6: 1000 mg/Day PLX3397 Combined With Eribulin | Treatments are given in 21 day cycles. For each cycle, treatment includes:
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 | 0 | 6 | 3 | 6 | 6 | 6 |
| EG006 | Phase II/1: 1000 mg/Day PLX3397 Combined With Eribulin | 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:
Treatment given in each 21 day cycle:
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 | 1 | 17 | 6 | 17 | 14 | 17 |
| EG007 | Phase II/2: 800 mg/Day PLX3397 Combined With Eribulin | 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:
Treatment given in each 21 day cycle:
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 | 0 | 22 | 14 | 22 | 22 | 22 |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Soft Tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and Infestations other | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Transient Ischemia Attack | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred Vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hpyerglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anzxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |