Solid Tumors
Conditions
Keywords
advanced, incurable solid tumors
Brief summary
This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Interventions
DRUGPLX3397
PLX3397 tablets, 200mg
DRUGPaclitaxel
Paclitaxel IV
Sponsors
Plexxikon
Daiichi Sankyo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with: * Part 1 (enrollment closed): an advanced, incurable solid tumor * Part 2 (enrollment closed): an advanced, incurable solid tumor for whom a taxane would be considered a reasonable chemotherapy option * Part 3 (enrollment closed): advanced, metastatic or non-resectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer with * platinum-resistant cancer, defined as disease that responded to a platinum-containing chemotherapy regimen, but demonstrated recurrence within six months following the completion of that platinum-containing regimen, OR * platinum-refractory cancer, defined as disease failed to achieve at least a partial response to a platinum-containing regimen (i.e., stable disease or actual disease progression), AND * have not been treated with a taxane within six months of Cycle 1 Day 1 (C1D1), AND * have not been treated with weekly paclitaxel after first-line treatment in which weekly paclitaxel plus a platinum is permitted * Part 3: Patients must have target (≥2 cm diameter) or non-target lesion cancer that is accessible for core biopsies before starting on study and after one cycle of treatment. * Patients with stable brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening. * Bone-directed therapy (e.g., bisphosphonates or denosumab) is permitted. * Washout from any prior investigational therapy of at least five times the T1/2 prior to C1D1 * Washout from any prior biologic or targeted therapy at least 4 weeks or five times the plasma half-life (T1/2) (whichever is shorter) prior to C1D1 * Washout from prior chemotherapy of at least 2 weeks or 1 elimination half-life, whichever is longer, prior to C1D1 * Washout from prior hormonal therapy of at least 2 weeks prior to C1D1 * Washout of at least 2 weeks from the most recent radiation treatment prior to C1D1 * Resolution of all prior treatment-related toxicities to Grade 1 or less, except for Grade 2 fatigue or alopecia prior to C1D1 * Age eighteen years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0-2, inclusive * Anticipated life expectancy of at least 12 weeks * Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1500/mm3, platelets ≥100,000/mm3 * Adequate renal function: serum creatinine \<1.5 x ULN or calculated creatinine clearance (CrCl) \>60 mL/min using Cockcroft-Gault formula * Adequate hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x upper limit of normal (ULN), Total and Direct Bilirubin \<1.5 x ULN. However, in the presence of liver metastases, AST and ALT must be \<5 x ULN * Cardiac ejection fraction ≥50%, and QT interval corrected by Fridericia's formula (QTcF) \<450 ms (males) or \<470 ms (females) on electrocardiogram (ECG) at Baseline. * Able to swallow capsules and maintain adequate hydration * Ability to give written informed consent and willing to comply with the requirements of the protocol; and for Part 3, to give written informed consent for 2 cancer biopsy procedures * Women of child-bearing potential must agree to use an effective method of birth control during treatment and for three months after receiving their last dose of study drug. Fertile men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after last dose.
Exclusion criteria
* Presence of an active secondary malignancy. * Patients with a non-melanomatous, in situ malignancy or disease that is completely resectable with surgery may be considered after discussion with the Medical Monitor * Patients with a completely treated prior malignancy with no evidence of disease for ≥3 years are eligible * Refractory nausea and vomiting, malabsorption, external biliary shunt or significant small bowel resection that would preclude adequate absorption of PLX3397 * Ongoing treatment with any other investigational therapy * Prior anaphylactic or severe hypersensitivity reaction to paclitaxel or Cremophor-containing agent. * Persistent grade 2 fatigue at Baseline. * Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol * Active untreated infection * Known chronic active Hepatitis B or C, or HIV infection * The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | From post first dose up to 28 days after the last dose, up to 5 years 9 months | Treatment-emergent adverse events (TEAEs) reported by \>10% of all participants in Parts 1 and 2 are reported. |
| Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | From post first dose up to 28 days after the last dose, up to 5 years 9 months | Treatment-emergent adverse events (TEAEs) reported by \>10% of all participants in Part 3 are reported. |
| Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | From post first dose up to 5 years 9 months post dose | Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | From 26 days (CR and PR) and 54 days (SD) up to 5 years 9 months post dose | Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | Cycle 1, Day 15 | — |
| A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | Cycle 1, Day 15 | — |
| Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose | — |
| Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | From post first dose up to 28 days after the last dose, up to 5 years 9 months | — |
| Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | From post first dose up to 28 days after the last dose, up to 5 years 9 months | — |
| Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | From post first dose up to 28 days after the last dose, up to 5 years 9 months | — |
| Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose | — |
| Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | From the first day of treatment to the first documented disease progression or date of death, whichever occurred first, up to 5 years 9 months post dose | Progression-free survival (PFS) is defined as the number of days from the start of therapy (i.e. Cycle 1 Day 1) to the date of first documented disease progression/relapse or death, whichever occurs first. If the disease progression/relapse does not occur, PFS will be censored as of the date of their last evaluable tumor assessments. |
| A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | Cycle 1, Day 15 | — |
Countries
United States
Participant flow
Recruitment details
A total of 74 participants (54 in Parts 1 and 2; 20 in Part 3) who met all inclusion and none of the exclusion criteria were enrolled in this study.
Pre-assignment details
An open-label study. In Part 1 (dose escalation), participants were sequentially enrolled and received doses of PLX3397 600 to 1600 mg/day. In Part 2 (dose expansion), PLX3397 was administered at the recommended phase 2 dose with paclitaxel. In Part 3, PLX3397 was administered at 600 mg twice daily with paclitaxel; 2 participants were not dosed.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Cohort 1; 600 mg/Day Participants with advanced solid tumors who received PLX3397 600 mg/day. | 9 |
| Part 1: Cohort 2; 800 mg/Day Participants with advanced solid tumors who received PLX3397 800 mg/day. | 3 |
| Part 1: Cohort 3; 1000 mg/Day Participants with advanced solid tumors who received PLX3397 1000 mg/day. | 3 |
| Part 1: Cohort 4; 1200 mg/Day Participants with advanced solid tumors who received PLX3397 1200 mg/day. | 6 |
| Part 1 and 2: Cohort 5; 1600 mg/Day Participants with advanced solid tumors who received PLX3397 1600 mg/day. | 33 |
| Part 3: PLX3397 600 mg BID All participants with advanced solid tumors who received PLX3397 600 mg BID as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m\^2 IV weekly. | 7 |
| Part 3: Paclitaxel 80 mg/m^2 All participants with advanced solid tumors who received paclitaxel 80 mg/m\^2 intravenous weekly as Cycle 1 lead-in treatment. After Cycle 1, participants were treated with PLX3397 600 mg BID and paclitaxel 80 mg/m\^2 IV weekly. | 5 |
| Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2 All participants who received PLX3397 600 mg BID + paclitaxel 80 mg/m\^2 intravenous weekly as Cycle 1 lead-in treatment. | 6 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 | 3 | 3 | 0 | 1 |
| Overall Study | Clinical progression | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Disease progression | 6 | 3 | 2 | 5 | 22 | 2 | 3 | 3 |
| Overall Study | Non-compliance | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 |
| Overall Study | Unqualified based on biopsy; not dosed | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1: Cohort 1; 600 mg/Day | Total | Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2 | Part 3: Paclitaxel 80 mg/m^2 | Part 3: PLX3397 600 mg BID | Part 1 and 2: Cohort 5; 1600 mg/Day | Part 1: Cohort 4; 1200 mg/Day | Part 1: Cohort 3; 1000 mg/Day | Part 1: Cohort 2; 800 mg/Day |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 14.2 | 59.5 years STANDARD_DEVIATION 10.9 | 59.7 years STANDARD_DEVIATION 8.8 | 64.8 years STANDARD_DEVIATION 4.9 | 64.0 years STANDARD_DEVIATION 10.4 | 58.9 years STANDARD_DEVIATION 10.7 | 58.7 years STANDARD_DEVIATION 16.4 | 60.3 years STANDARD_DEVIATION 11.1 | 55.0 years STANDARD_DEVIATION 5.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 65 Participants | 5 Participants | 5 Participants | 7 Participants | 29 Participants | 5 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 9 participants | 72 participants | 6 participants | 5 participants | 7 participants | 33 participants | 6 participants | 3 participants | 3 participants |
| Sex: Female, Male Female | 6 Participants | 51 Participants | 6 Participants | 5 Participants | 7 Participants | 20 Participants | 3 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 21 Participants | 0 Participants | 0 Participants | 0 Participants | 13 Participants | 3 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 9 | 0 / 3 | 1 / 3 | 1 / 6 | 5 / 33 | 1 / 7 | 1 / 6 | 1 / 7 |
| other Total, other adverse events | 9 / 9 | 3 / 3 | 3 / 3 | 6 / 6 | 33 / 33 | 7 / 7 | 5 / 5 | 6 / 6 |
| serious Total, serious adverse events | 1 / 9 | 1 / 3 | 3 / 3 | 2 / 6 | 10 / 33 | 5 / 7 | 2 / 5 | 3 / 6 |
Outcome results
Primary
Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From 26 days (CR and PR) and 54 days (SD) up to 5 years 9 months post dose
Population: Best overall tumor response was assessed in the Efficacy Evaluable Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Partial response (PR) | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 50 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Stable disease (SD) | 50 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Progressive disease (PD) | 50 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Stable disease (SD) | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Partial response (PR) | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Progressive disease (PD) | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 40 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Partial response (PR) | 20 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Stable disease (SD) | 20 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Progressive disease (PD) | 60 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 20 percentage of participants |
Primary
Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)
Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From post first dose up to 5 years 9 months post dose
Population: Best overall tumor response was assessed in the Efficacy Evaluable Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Partial response (PR) | 17 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Unable to assess | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 17 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 50 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Stable disease | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Progressive disease | 50 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Stable disease | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Progressive disease | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Partial response (PR) | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Unable to assess | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Partial response (PR) | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Stable disease | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Progressive disease | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Unable to assess | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Unable to assess | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Stable disease | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Partial response (PR) | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Complete response (CR) | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Progressive disease | 33 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Complete response (CR) | 5 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Partial response (PR) | 10 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Clinical benefit rate (CR, PR, or stable disease) | 45 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Unable to assess | 10 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Progressive disease | 45 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Best overall response rate (CR or PR) | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | Stable disease | 30 percentage of participants |
Primary
Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population)
Treatment-emergent adverse events (TEAEs) reported by \>10% of all participants in Part 3 are reported.
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Population: Safety events were assessed in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Blood bilirubin increased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dysgeusia | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Abdominal distension | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Aspartate aminotransferase increased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neuropathy peripheral | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Injury, poisoning, and procedural complications | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Alanine aminotransferase increased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dizziness | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Abdominal pain | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Investigations | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Headache | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Nausea | 71.4 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Myalgia | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Skin and subcutaneous tissue disorders | 57.1 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Renal and urinary disorders | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pain in extremity | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Alopecia | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Stomatitis | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Musculoskeletal and connective tissue disorders | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pruritus | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vaginal hemorrhage | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Oropharyngeal pain | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Rash | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pneumonia | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Cough | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Colitis | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Epistaxis | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dyspnea | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Hypertension | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Infections and infestations | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Toothache | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Diarrhea | 57.1 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neutropenia | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | General disorders/administrative site conditions | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Reproductive system and breast disorders | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Anemia | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Fatigue | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vascular disorders | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Blood and lymphatic system disorders | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Chills | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Constipation | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Contusion | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Edema peripheral | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Gastrointestinal disorders | 100 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Decreased appetite | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Urinary incontinence | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Metabolism and nutrition disorders | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Chest pain | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vomiting | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Face edema | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Lymphocyte count decreased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Nervous system disorders | 57.1 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dysuria | 14.3 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Decreased appetite | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Gastrointestinal disorders | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Nausea | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Diarrhea | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Constipation | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vomiting | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Abdominal distension | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Abdominal pain | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Stomatitis | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Colitis | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Toothache | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | General disorders/administrative site conditions | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Fatigue | 80 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Chills | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Edema peripheral | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Chest pain | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Face edema | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Nervous system disorders | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dysgeusia | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neuropathy peripheral | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dizziness | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Headache | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Skin and subcutaneous tissue disorders | 80 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Alopecia | 80 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pruritus | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Rash | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 80 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dyspnea | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Epistaxis | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Cough | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Oropharyngeal pain | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Musculoskeletal and connective tissue disorders | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pain in extremity | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Myalgia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Investigations | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Alanine aminotransferase increased | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Aspartate aminotransferase increased | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Blood bilirubin increased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Lymphocyte count decreased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Metabolism and nutrition disorders | 60 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Blood and lymphatic system disorders | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Anemia | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neutropenia | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Infections and infestations | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pneumonia | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Renal and urinary disorders | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dysuria | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Urinary incontinence | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vascular disorders | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Hypertension | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Injury, poisoning, and procedural complications | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Contusion | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Reproductive system and breast disorders | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vaginal hemorrhage | 20 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Aspartate aminotransferase increased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Nervous system disorders | 66.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Urinary incontinence | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Blood bilirubin increased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Face edema | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Diarrhea | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Lymphocyte count decreased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Chest pain | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neutrophil count decreased | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pyrexia | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vascular disorders | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Metabolism and nutrition disorders | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Edema peripheral | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Chills | 66.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Decreased appetite | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Fatigue | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Nausea | 66.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Blood and lymphatic system disorders | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | General disorders/administrative site conditions | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vaginal hemorrhage | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Anemia | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Toothache | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Hypertension | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neutropenia | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Colitis | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Gastrointestinal disorders | 83.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Infections and infestations | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Stomatitis | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Reproductive system and breast disorders | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dyspnea | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 66.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pneumonia | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Epistaxis | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Rash | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Abdominal pain | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Cough | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pruritus | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Injury, poisoning, and procedural complications | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Oropharyngeal pain | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Alopecia | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Renal and urinary disorders | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Musculoskeletal and connective tissue disorders | 66.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Skin and subcutaneous tissue disorders | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Vomiting | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Pain in extremity | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Headache | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Abdominal distension | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Myalgia | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dizziness | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dysuria | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Investigations | 66.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Neuropathy peripheral | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Constipation | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Alanine aminotransferase increased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Dysgeusia | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population) | Contusion | 16.7 percentage of participants |
Primary
Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population)
Treatment-emergent adverse events (TEAEs) reported by \>10% of all participants in Parts 1 and 2 are reported.
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Population: Safety events were assessed in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Periorbital edema | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nausea | 44 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Eye disorders | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dizziness | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood and lymphatic disorders | 89 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Constipation | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Aspartate aminotransferase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dysgeusia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Anemia | 78 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Rash | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypertension | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | General disorders/administrative site conditions | 89 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nervous system disorders | 44 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutropenia | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Lymphocyte count decreased | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pruritus | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Investigations | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Weight decreased | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Metabolism and nutrition disorders | 78 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vascular disorders | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vision blurred | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Fatigue | 78 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory rate increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Decreased appetite | 78 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dyspnea | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Diarrhea | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | White blood cell count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood alkaline phosphatase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypokalemia | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Gastrointestinal disorders | 89 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Headache | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Edema peripheral | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alanine aminotransferase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypophosphatemia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Insomnia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Psychiatric disorders | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutrohil count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Skin and subcutaneous disorders | 56 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Cough | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neuropathy peripheral | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood creatinine phosphokinase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alopecia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pyrexia | 22 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Insomnia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | White blood cell count decreased | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Rash | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Lymphocyte count decreased | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pruritus | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Aspartate aminotransferase increased | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vomiting | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Investigations | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dyspnea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Cough | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Eye disorders | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Constipation | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Gastrointestinal disorders | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypertension | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | General disorders/administrative site conditions | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vascular disorders | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Fatigue | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Psychiatric disorders | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Headache | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Edema peripheral | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neuropathy peripheral | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dizziness | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood and lymphatic disorders | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nausea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dysgeusia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Anemia | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Periorbital edema | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nervous system disorders | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutropenia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vision blurred | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Weight decreased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Metabolism and nutrition disorders | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory rate increased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Decreased appetite | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood alkaline phosphatase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypokalemia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Diarrhea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alanine aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypophosphatemia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutrohil count decreased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Skin and subcutaneous disorders | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood creatinine phosphokinase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alopecia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Skin and subcutaneous disorders | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Gastrointestinal disorders | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nausea | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Diarrhea | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Constipation | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | General disorders/administrative site conditions | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Fatigue | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Edema peripheral | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pyrexia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood and lymphatic disorders | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Anemia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutropenia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Metabolism and nutrition disorders | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Decreased appetite | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypokalemia | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypophosphatemia | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alopecia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Rash | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pruritus | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dyspnea | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Cough | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Investigations | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Aspartate aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Lymphocyte count decreased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | White blood cell count decreased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood creatinine phosphokinase increased | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutrohil count decreased | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alanine aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood alkaline phosphatase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory rate increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Weight decreased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nervous system disorders | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dysgeusia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dizziness | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neuropathy peripheral | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Headache | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vascular disorders | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypertension | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Eye disorders | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Periorbital edema | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vision blurred | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Psychiatric disorders | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Insomnia | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nausea | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory rate increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Edema peripheral | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Gastrointestinal disorders | 83 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neuropathy peripheral | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypokalemia | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Fatigue | 83 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Insomnia | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Headache | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutropenia | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | White blood cell count decreased | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | General disorders/administrative site conditions | 100 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Psychiatric disorders | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vascular disorders | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alanine aminotransferase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Weight decreased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Constipation | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypophosphatemia | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypertension | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Periorbital edema | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Anemia | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vision blurred | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dyspnea | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nervous system disorders | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Cough | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Decreased appetite | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutrohil count decreased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Eye disorders | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Investigations | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood and lymphatic disorders | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood alkaline phosphatase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pruritus | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dysgeusia | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Aspartate aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood creatinine phosphokinase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Skin and subcutaneous disorders | 100 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Rash | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pyrexia | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Lymphocyte count decreased | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Metabolism and nutrition disorders | 83 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dizziness | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alopecia | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Diarrhea | 50 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | General disorders/administrative site conditions | 79 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | White blood cell count decreased | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Skin and subcutaneous disorders | 55 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood creatinine phosphokinase increased | 39 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypophosphatemia | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutrohil count decreased | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypokalemia | 27 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Periorbital edema | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alanine aminotransferase increased | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Decreased appetite | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nausea | 42 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood alkaline phosphatase increased | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Metabolism and nutrition disorders | 67 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory rate increased | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neutropenia | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Insomnia | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Weight decreased | 6 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Anemia | 67 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Nervous system disorders | 55 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Blood and lymphatic disorders | 73 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vision blurred | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dysgeusia | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pyrexia | 18 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Gastrointestinal disorders | 91 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dizziness | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Edema peripheral | 27 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Neuropathy peripheral | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Fatigue | 70 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Headache | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vascular disorders | 39 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Constipation | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Psychiatric disorders | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Hypertension | 30 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Vomiting | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Dyspnea | 33 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Any TEAE | 100 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Cough | 18 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Respiratory, thoracic, and mediastinal disorders | 61 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Investigations | 61 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Pruritus | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Eye disorders | 30 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Aspartate aminotransferase increased | 42 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Rash | 27 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Diarrhea | 39 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Lymphocyte count decreased | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) | Alopecia | 24 percentage of participants |
Secondary
A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3)
Time frame: Cycle 1, Day 15
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | 3420 ng/mL | Geometric Coefficient of Variation 41.4 |
| Part 1: Cohort 2; 800 mg/Day | A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | 6640 ng/mL | Geometric Coefficient of Variation 26.5 |
| Part 1: Cohort 3; 1000 mg/Day | A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | 4340 ng/mL | Geometric Coefficient of Variation 27.6 |
| Part 1: Cohort 4; 1200 mg/Day | A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | 8190 ng/mL | Geometric Coefficient of Variation 39.6 |
| Part 1 and 2: Cohort 5; 1600 mg/Day | A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | 8000 ng/mL | Geometric Coefficient of Variation 50.5 |
| Part 3: 1200 mg (600 mg BID) | A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3) | 8540 ng/mL | Geometric Coefficient of Variation 17.8 |
Secondary
A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3)
Time frame: Cycle 1, Day 15
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set, except for AUC(0-6) which was not performed for Part 1 and 2 participants, only participants in Part 3.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-4) | 12400 h*ng/mL | Geometric Coefficient of Variation 41 |
| Part 1: Cohort 1; 600 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-12) | 36900 h*ng/mL | Geometric Coefficient of Variation 37.1 |
| Part 1: Cohort 2; 800 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-4) | 21700 h*ng/mL | Geometric Coefficient of Variation 25.7 |
| Part 1: Cohort 2; 800 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-12) | 59300 h*ng/mL | Geometric Coefficient of Variation 16 |
| Part 1: Cohort 3; 1000 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-12) | 44400 h*ng/mL | Geometric Coefficient of Variation 30.7 |
| Part 1: Cohort 3; 1000 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-4) | 13100 h*ng/mL | Geometric Coefficient of Variation 38.6 |
| Part 1: Cohort 4; 1200 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-12) | 75600 h*ng/mL | Geometric Coefficient of Variation 34.2 |
| Part 1: Cohort 4; 1200 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-4) | 28000 h*ng/mL | Geometric Coefficient of Variation 34.5 |
| Part 1 and 2: Cohort 5; 1600 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-12) | 70500 h*ng/mL | Geometric Coefficient of Variation 36.7 |
| Part 1 and 2: Cohort 5; 1600 mg/Day | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-4) | 26500 h*ng/mL | Geometric Coefficient of Variation 46.5 |
| Part 3: 1200 mg (600 mg BID) | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-12) | 71700 h*ng/mL | Geometric Coefficient of Variation 21.2 |
| Part 3: 1200 mg (600 mg BID) | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-4) | 27800 h*ng/mL | Geometric Coefficient of Variation 17.5 |
| Part 3: 1200 mg (600 mg BID) | A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3) | AUC (0-6) | 40100 h*ng/mL | Geometric Coefficient of Variation 19.4 |
Secondary
A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3)
Time frame: Cycle 1, Day 15
Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | 0 hours |
| Part 1: Cohort 2; 800 mg/Day | A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | 2 hours |
| Part 1: Cohort 3; 1000 mg/Day | A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | 0 hours |
| Part 1: Cohort 4; 1200 mg/Day | A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | 2 hours |
| Part 1 and 2: Cohort 5; 1600 mg/Day | A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | 2 hours |
| Part 3: 1200 mg (600 mg BID) | A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3) | 2 hours |
Secondary
Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Time frame: From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose
Population: Duration of response based on patients with CR or PR was assessed in the Efficacy Evaluable Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Cohort 2; 800 mg/Day | Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | 119 days |
| Part 1: Cohort 3; 1000 mg/Day | Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | 114 days |
Secondary
Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)
Time frame: From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose
Population: Duration of response was assessed in the Efficacy Evaluable Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | 171 days | Standard Deviation 0 |
| Part 1: Cohort 3; 1000 mg/Day | Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | 9 days | Standard Deviation 0 |
| Part 1: Cohort 4; 1200 mg/Day | Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | 66 days | Standard Deviation 0 |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population) | 113.3 days | Standard Deviation 68.8 |
Secondary
Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Edema peripheral | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Lymphocyte count decreased | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 67 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neuropathy peripheral | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alopecia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 89 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 44 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 67 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutropenia | 22 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Lymphocyte count decreased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Edema peripheral | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutropenia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neuropathy peripheral | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alopecia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neuropathy peripheral | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Lymphocyte count decreased | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alopecia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Edema peripheral | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutropenia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 100 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 83 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Edema peripheral | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutropenia | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alopecia | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Lymphocyte count decreased | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neuropathy peripheral | 17 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 6 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alopecia | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 27 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutropenia | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 94 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 64 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Edema peripheral | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 52 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neuropathy peripheral | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 30 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 33 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Lymphocyte count decreased | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 42 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 33 percentage of participants |
Secondary
Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Abdominal distension | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Alanine aminotransferase increased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Aspartate aminotransferase increased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Stomatitis | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Lymphocyte count decreased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Diarrhea | 57.1 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Decreased appetite | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Fatigue | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Anemia | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neutropenia | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Blood bilirubin increased | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Chills | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Any related TEAE | 85.7 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Edema peripheral | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Constipation | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Dysgeusia | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neuropathy peripheral | 28.6 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Nausea | 57.1 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Dizziness | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Vomiting | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Alopecia | 42.9 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Pruritus | 14.3 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Myalgia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Diarrhea | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Vomiting | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Alanine aminotransferase increased | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Abdominal distension | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Chills | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Aspartate aminotransferase increased | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Any related TEAE | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Blood bilirubin increased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Myalgia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Dizziness | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Lymphocyte count decreased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Stomatitis | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Edema peripheral | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Pruritus | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Nausea | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Decreased appetite | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Dysgeusia | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Constipation | 40 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Anemia | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Fatigue | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Alopecia | 80 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neutropenia | 20 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neuropathy peripheral | 40 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neutropenia | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Any related TEAE | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Nausea | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Diarrhea | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Constipation | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Vomiting | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Abdominal distension | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Stomatitis | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Fatigue | 83.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Chills | 50 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Edema peripheral | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Dysgeusia | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neuropathy peripheral | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Dizziness | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Alopecia | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Pruritus | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Myalgia | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Alanine aminotransferase increased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Aspartate aminotransferase increased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Blood bilirubin increased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Lymphocyte count decreased | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Neutrophil count decreased | 33.3 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Decreased appetite | 16.7 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set) | Anemia | 33.3 percentage of participants |
Secondary
Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 89 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypertension | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 11 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Periorbital edema | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 33 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 22 percentage of participants |
| Part 1: Cohort 1; 600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypertension | 67 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Periorbital edema | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 100 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 0 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 33 percentage of participants |
| Part 1: Cohort 2; 800 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 100 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 67 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 33 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypertension | 0 percentage of participants |
| Part 1: Cohort 3; 1000 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Periorbital edema | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypertension | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 66 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 100 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 83 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 33 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 67 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 50 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 17 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Periorbital edema | 0 percentage of participants |
| Part 1: Cohort 4; 1200 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 33 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Nausea | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Decreased appetite | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Vomiting | 27 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Periorbital edema | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | White blood cell count decreased | 33 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Rash | 27 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Anemia | 36 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypertension | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood alkaline phosphatase increased | 18 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Blood creatinine phosphokinase increased | 39 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Aspartate aminotransferase increased | 42 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pyrexia | 12 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Any Paclitaxel-related TEAE | 94 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Diarrhea | 24 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Neutrophil count decreased | 21 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Hypophosphatemia | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Fatigue | 64 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Pruritus | 15 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Dysgeusia | 30 percentage of participants |
| Part 1 and 2: Cohort 5; 1600 mg/Day | Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set) | Alanine aminotransferase increased | 21 percentage of participants |
Secondary
Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Progression-free survival (PFS) is defined as the number of days from the start of therapy (i.e. Cycle 1 Day 1) to the date of first documented disease progression/relapse or death, whichever occurs first. If the disease progression/relapse does not occur, PFS will be censored as of the date of their last evaluable tumor assessments.
Time frame: From the first day of treatment to the first documented disease progression or date of death, whichever occurred first, up to 5 years 9 months post dose
Population: Progression-free survival was assessed in the Efficacy Evaluable Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Cohort 1; 600 mg/Day | Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | 117 days |
| Part 1: Cohort 2; 800 mg/Day | Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | 59 days |
| Part 1: Cohort 3; 1000 mg/Day | Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population) | 56 days |