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Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 1/2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory FLT3-ITD Positive Acute Myeloid Leukemia (AML)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01349049
Enrollment
90
Registered
2011-05-06
Start date
2011-11-21
Completion date
2018-01-09
Last updated
2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

AML, relapsed, refractory

Brief summary

The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.

Detailed description

Protocol PLX108-05 is a Phase 1/2 open-label, sequential dose escalation (Part 1) followed by cohort expansion (Part 2) design at the recommended phase 2 dose established in Part 1 (i.e. 3,000 mg/day). Treatment with PLX3397 will consist of continuous oral administration in 28-day cycles until unacceptable or dose-limiting toxicity, disease progression or relapse, patient death, Investigator decision, or voluntary withdrawal.

Interventions

Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily.

Sponsors

Plexxikon
CollaboratorINDUSTRY
Daiichi Sankyo
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female patients ≥18 years old. * Morphologically documented primary Acute Myeloid Leukemia (AML), prior-chemotherapy-related AML or AML secondary to an antecedent hematologic disorder (e.g., Myelodysplastic Syndrome) as defined by World Health Organization criteria, confirmed by pathology review. For Cohort Expansion Phase (Part 2) only: Bone marrow involvement is required. * Have either relapsed or refractory AML, or who have newly diagnosed Flt3-ITD positive AML but either refuse or are considered by the Investigator not to be an appropriate candidate for standard chemotherapy. 1. Relapsed disease is defined as the reappearance of leukemia cells in the bone marrow or peripheral blood or elsewhere in the body (other tissues/organs) after the attainment of a CR. 2. Refractory disease is defined by the failure to obtain a complete remission (CR) with a High-Dose Cytarabine (HDAC)-containing or a standard induction regimen. Patients who require two cycles of induction therapy to attain a first CR are not considered to have refractory disease. * Positive for Flt3-ITD activating mutations during Screening. Local laboratory results must be received prior to enrollment. Patients with a history of Flt3-ITD positive disease may be considered after discussion with the Medical Monitor. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Adequate recovery (to at least Grade 1) from toxicity of prior therapy as follows: 1. ≥2 weeks for cytotoxic therapy (except hydroxyurea, which is permitted at doses of ≤5g/day during the first 2 weeks of Cycle 1) prior to C1D1. 2. ≥4 half-lives for non-cytotoxic therapy prior to C1D1. Patients must have a wash-out period from their last chemotherapy of either ≥2 weeks OR at least 4 half-lives prior to C1D1. For patients whose most recent anti-tumor treatment regimen consisted of a multi-agent cocktail, the patient must have a wash-out period of at least 4 half-lives of the agent with the longest half-life. * Adequate hepatic and renal function 1. Adequate renal function, defined as Creatinine Clearance \>60 mL/min or serum creatinine of ≤ 1.3 mg/dL (115 μM). 2. Adequate hepatic function, defined as Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤3.0X Upper limit of normal (ULN) and serum direct bilirubin ≤1.5X ULN. Exceptions may be made for patients with elevated liver transaminases secondary to AML after discussion with the Medical Monitor * Life expectancy of at least 1 month * Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements and for 3 months after last dose. * Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use two acceptable methods of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they meet at least one of the following criteria: 1. Surgically sterile 2. Have been postmenopausal for ≥1 year 3. Have Follicle Stimulating Hormone (FSH) levels indicative of postmenopausal state (i.e., 30-120 IU/L) documented within 21 days of C1D1. Sexually active men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after the last dose

Exclusion criteria

* Diagnosis of acute promyelocytic leukemia * Diagnosis of chronic myelogenous leukemia in blast crisis * Presence of central nervous system (CNS) involvement of leukemia. Patients with a history of CNS involvement may be considered after discussion with the Medical Monitor * Patients eligible for Hematopoietic Stem Cell Transplantation (HSCT) at the time of screening. However, patients who meet one or both of the following criteria may be eligible for study participation: 1. Patients who are eligible for HSCT but with non-optimal AML disease control (i.e., blasts \> 5%) may be enrolled into this study as a bridge-to-transplant. 2. Patients with relapsed disease following a prior HSCT may be enrolled into this study as an alternative to a second HSCT or as a bridge-to-transplant regimen. * For both Parts 1 and 2, receipt of HSCT within 60 days of the first dose of PLX3397 is an exclusion criterion. Patients on immunosuppressive therapy post HSCT, or with clinically significant graft-versus-host disease are excluded from Part 1. (Use of topical steroids for ongoing skin Graft vs. host disease \[GVHD\] is permitted). Patients for Part 1 must have a wash-out period of ≥2 weeks or at least 4 half-lives from their last systemic immunosuppressive treatment for Graft vs. host disease. Patients for Part 2 may be receiving systemic immunosuppressive treatment for management of GVHD at the time of screening and enrollment * Investigational drug use within 28 days of the first dose of PLX3397 * For Cohort Expansion Phase (Part 2) only: Patients who are positive for the D835 mutation at Screening are excluded. * A concurrent active cancer that requires non-surgical therapy (e.g., chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there is no active disease within 1 year of the first dose of PLX3397. * Refractory nausea and vomiting, malabsorption, biliary shunt significant bowel resection, GVHD affecting the gut, or any other condition that would preclude adequate absorption * Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results * Women of child-bearing potential who are pregnant or breast feeding * At Screening, QT interval, Frederica's formula (QTcF) \>450 msec for males; QTcF \>470 msec for females * Patients with a history of D835 mutations

Design outcomes

Primary

MeasureTime frameDescription
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)1 year post doseMedian survival estimates were based on the Kaplan-Meier method. In the event disease progression/relapse or death was not documented prior to study termination, endpoints were censored at the date of last evaluable tumor assessment. Duration of remission, duration of complete remission, and disease-free survival, initial response was based on the modified response criteria. Duration of complete remission was defined as the number of days from the date of initial CR, CRp, or CRi response to the date of first documented disease relapse or death, whichever occurred first. Disease-free survival was defined as the number of days from the date of initial CR, CRp, or CRi to the date of documented disease relapse or death from any cause, whichever occurred first.
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).1 year post doseComplete remission (CR): Has bone marrow regenerating normal cells, achieve a morphologic leukemia-free state, Complete remission with incomplete platelet recovery (CRp): CR except for incomplete platelet recovery, Complete remission with incomplete recovery (CRi): CR except for incomplete hematological recovery with residual neutropenia, Partial response (PR): bone marrow generates normal hematopoietic cells, evidence of peripheral recovery with no or a few regenerating circulating blasts. Decrease of ≥50% of blasts in bone marrow aspirate, total marrow blasts between 5% -25%, Non-response (NR) were assessed using modified International Working Group (IWG) response criteria for AML. Successfully (BTT) patients and successfully BTT patients (CR, CRp, or CRi) are also reported. Successfully BTT is defined as any patient who discontinued PLX3397 treatment specifically for the purpose of undergoing a hematopoietic stem cell transplant and who subsequently received the planned transplant.

Secondary

MeasureTime frameDescription
Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)1 year post doseComplete Remission (CR): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/μL); platelet count \>100 x 109/L (100000/μL); red cell transfusion independent CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 x 109/L) or thrombocytopenia Partial Remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5-25%; decrease of pretreatment bone marrow blast percentage by at least 50%.
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)1 year post dose
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)1 year post doseData reported are Treatment Emergent Adverse Events with a CTCAE Grade ≥3 During Treatment that are ≥10% Occurrence in all patients.
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)1 year post dose
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)1 year post doseData reported are Treatment-Related Treatment Emergent Adverse Events that are ≥15% Occurrence in all patients.
Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2)1 year post doseModified International Working Group Response Criteria for Acute Myeloid Leukemia defines Partial Remission (PR) as the following: Partial Remission (PR): Patients must have bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. In addition, patients do not need to be Red Blood Cell (RBC) or platelet transfusion independent.

Other

MeasureTime frame
A Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)1 year post dose

Countries

United States

Participant flow

Recruitment details

A total of 90 participants (34 in Part 1 and 56 in part 2) were enrolled in the study and received PLX3397.

Pre-assignment details

The study participants enrolled are patients with relapsed or refractory Flt3-ITD+ AML, or newly diagnosed Flt3-ITD + AML patients who either refused or were considered not to be appropriate candidates for chemotherapy.

Participants by arm

ArmCount
Part 1: 800 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
3
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
7
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
3
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day
3
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day
3
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
6
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day
5
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day
4
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
56
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudyAdverse Event010003104
Overall StudyDeath000000015
Overall StudyDisease progression3532223233
Overall StudyHematopoietic stem cell transplant000010110
Overall StudyNon-compliance000100000
Overall StudyOther000001004
Overall StudyPhysician Decision010000002
Overall StudyProtocol Violation000000001
Overall StudyWithdrawal by Subject000000006

Baseline characteristics

CharacteristicPart 1: 800 mg/DayTotalPart 2: 3000 mg/DayPart 1: 5000 mg/DayPart 1: 4000 mg/DayPart 1: 3000 mg/DayPart 1: 2000 mg/DayPart 1: 1400 mg/DayPart 1: 1200 mg/DayPart 1: 1000 mg/Day
Age, Continuous58.0 years
STANDARD_DEVIATION 28.2
57.7 years
STANDARD_DEVIATION 14.72
55.9 years
STANDARD_DEVIATION 14.6
63.8 years
STANDARD_DEVIATION 2.5
54.8 years
STANDARD_DEVIATION 14.5
61.0 years
STANDARD_DEVIATION 9.7
70.7 years
STANDARD_DEVIATION 11.2
61.7 years
STANDARD_DEVIATION 19.7
65.7 years
STANDARD_DEVIATION 12.9
56.7 years
STANDARD_DEVIATION 18.5
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants4 Participants3 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants14 Participants7 Participants0 Participants1 Participants1 Participants0 Participants0 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants15 Participants11 Participants1 Participants1 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants56 Participants35 Participants2 Participants3 Participants5 Participants3 Participants2 Participants2 Participants2 Participants
Region of Enrollment
United States
3 participants90 participants56 participants4 participants5 participants6 participants3 participants3 participants3 participants7 participants
Sex: Female, Male
Female
0 Participants44 Participants23 Participants3 Participants4 Participants4 Participants1 Participants2 Participants2 Participants5 Participants
Sex: Female, Male
Male
3 Participants46 Participants33 Participants1 Participants1 Participants2 Participants2 Participants1 Participants1 Participants2 Participants

Adverse events

Event typeEG000
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
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 70 / 30 / 30 / 30 / 60 / 51 / 45 / 56
other
Total, other adverse events
3 / 37 / 73 / 33 / 33 / 36 / 65 / 54 / 456 / 56
serious
Total, serious adverse events
1 / 35 / 72 / 31 / 32 / 35 / 64 / 54 / 439 / 56

Outcome results

Primary

Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).

Complete remission (CR): Has bone marrow regenerating normal cells, achieve a morphologic leukemia-free state, Complete remission with incomplete platelet recovery (CRp): CR except for incomplete platelet recovery, Complete remission with incomplete recovery (CRi): CR except for incomplete hematological recovery with residual neutropenia, Partial response (PR): bone marrow generates normal hematopoietic cells, evidence of peripheral recovery with no or a few regenerating circulating blasts. Decrease of ≥50% of blasts in bone marrow aspirate, total marrow blasts between 5% -25%, Non-response (NR) were assessed using modified International Working Group (IWG) response criteria for AML. Successfully (BTT) patients and successfully BTT patients (CR, CRp, or CRi) are also reported. Successfully BTT is defined as any patient who discontinued PLX3397 treatment specifically for the purpose of undergoing a hematopoietic stem cell transplant and who subsequently received the planned transplant.

Time frame: 1 year post dose

Population: Efficacy analyses were conducted in the Part 2 Efficacy Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).CRp1 Participants
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).NR45 Participants
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).Successful BTT patient (CR, CRp, or CRi)8 Participants
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).CR1 Participants
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).CRi4 Participants
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).PR5 Participants
Part 2: 3000 mg/DaySummary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).Successful BTT patients4 Participants
Primary

Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)

Median survival estimates were based on the Kaplan-Meier method. In the event disease progression/relapse or death was not documented prior to study termination, endpoints were censored at the date of last evaluable tumor assessment. Duration of remission, duration of complete remission, and disease-free survival, initial response was based on the modified response criteria. Duration of complete remission was defined as the number of days from the date of initial CR, CRp, or CRi response to the date of first documented disease relapse or death, whichever occurred first. Disease-free survival was defined as the number of days from the date of initial CR, CRp, or CRi to the date of documented disease relapse or death from any cause, whichever occurred first.

Time frame: 1 year post dose

Population: Time-to-event analyses were assessed in the Part 2 Efficacy Population.

ArmMeasureGroupValue (MEDIAN)
Part 2: 3000 mg/DaySummary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)Duration of remission91 days
Part 2: 3000 mg/DaySummary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)Duration of complete remission289 days
Part 2: 3000 mg/DaySummary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)Progression-free survival48 days
Part 2: 3000 mg/DaySummary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)Disease-free survival289 days
Part 2: 3000 mg/DaySummary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)Overall survival112 days
Secondary

Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)

Time frame: 1 year post dose

Population: Adverse events were assessed in the Safety Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE1 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=33 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE3 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE2 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=37 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event2 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE7 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug2 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration4 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE4 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE5 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE2 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE3 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration2 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE3 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=32 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug0 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE3 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=33 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE3 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE2 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug0 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE3 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration2 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=32 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE3 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=35 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug3 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death3 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE4 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event1 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE6 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration5 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE5 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event0 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug2 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE5 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE4 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE4 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=35 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration4 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration3 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE4 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death0 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE4 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event1 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE4 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug0 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=34 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)SAE leading to discontinuation of study drug9 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE56 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related AE49 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE that lead to change in drug administration28 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 AE with CTCAE Grade >=350 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Serious Adverse Event (SAE)or other significant AE39 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)At least 1 treatment-related Serious Adverse Event10 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)AE resulting in death9 Participants
Secondary

Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)

Data reported are Treatment-Related Treatment Emergent Adverse Events that are ≥15% Occurrence in all patients.

Time frame: 1 year post dose

Population: Adverse events were assessed in the Safety Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite1 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE2 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea2 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea1 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting2 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE4 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia1 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea1 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea1 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea1 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE3 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea2 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE3 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea3 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting2 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia2 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE3 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea0 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting0 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia2 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE4 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting2 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea0 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue2 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite2 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea2 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia2 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia0 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE4 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting1 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea3 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite1 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea1 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting3 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea3 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue2 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia2 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite1 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE4 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia2 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea1 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue18 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Decreased appetite16 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Diarrhoea19 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia9 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Nausea21 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased10 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 treatment-related AE49 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Dysgeusia6 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Vomiting15 Participants
Secondary

Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)

Data reported are Treatment Emergent Adverse Events with a CTCAE Grade ≥3 During Treatment that are ≥10% Occurrence in all patients.

Time frame: 1 year post dose

Population: Adverse events were assessed in the Safety Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥33 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue2 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia1 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia1 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue0 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥37 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia5 Participants
Part 1: 1000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis1 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia1 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥32 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥33 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia3 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia1 Participants
Part 1: 1400 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased1 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis0 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥32 Participants
Part 1: 2000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia1 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis1 Participants
Part 1: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥35 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis0 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia2 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased1 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia2 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥35 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue0 Participants
Part 1: 4000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥34 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia2 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia3 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis0 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue1 Participants
Part 1: 5000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased10 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Fatigue3 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Sepsis10 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)At least 1 AE with CTCAE Grade ≥350 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia7 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Febrile neutropenia22 Participants
Part 2: 3000 mg/DayNumber of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia9 Participants
Secondary

Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)

Time frame: 1 year post dose

Population: Adverse events were assessed in the Safety Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia2 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis1 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia2 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 1: 1000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia1 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia1 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 1200 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia2 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia1 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia1 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia1 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 1: 1400 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased2 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis0 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia1 Participants
Part 1: 2000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia1 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia1 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis1 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia1 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased1 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia2 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia2 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia2 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 4000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia3 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased2 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia2 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia2 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia2 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia3 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased1 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 1: 5000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lipase increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood bilirubin increased7 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperkalaemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypophosphataemia7 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperchloraemia2 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Alanine aminotransferase increased6 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukopenia2 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Bilirubin conjugated increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyponatraemia5 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Carbon monoxide diffusing capacity decreased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood creatinine phosphokinase increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood uric acid increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood urea decreased2 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Anaemia15 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Activated partial thromboplastin time prolonged2 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypernatraemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Myeloblast count increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Gamma glutamyl transferase increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood alkaline phosphatase increase10 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperuricaemia3 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blast cell count increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperbilirubinaemia1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Platelet count decreased12 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood cholesterol increased3 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperphosphataemia0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypocalcaemia8 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Globulins increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Transaminases increased5 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Leukocytosis2 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Aspartate aminotransferase increased13 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutrophil count decreased6 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood albumin decreased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Lymphocyte count decreased7 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Troponin increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypomagnesmia10 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)INR increased0 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood chloride increased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Neutropenia4 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Thrombocytopenia9 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)White blood cell count decreased7 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Blood fibrinogen decreased1 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypoalbuminaemia8 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hyperglycaemia9 Participants
Part 2: 3000 mg/DayNumber of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Hypokalaemia13 Participants
Secondary

Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)

Complete Remission (CR): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/μL); platelet count \>100 x 109/L (100000/μL); red cell transfusion independent CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 x 109/L) or thrombocytopenia Partial Remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5-25%; decrease of pretreatment bone marrow blast percentage by at least 50%.

Time frame: 1 year post dose

Population: Efficacy analyses were conducted in the Part 2 Efficacy Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DayNumber of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)CR2 Participants
Part 2: 3000 mg/DayNumber of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)CRi6 Participants
Part 2: 3000 mg/DayNumber of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)PR2 Participants
Part 2: 3000 mg/DayNumber of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)NR46 Participants
Secondary

Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2)

Modified International Working Group Response Criteria for Acute Myeloid Leukemia defines Partial Remission (PR) as the following: Partial Remission (PR): Patients must have bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. In addition, patients do not need to be Red Blood Cell (RBC) or platelet transfusion independent.

Time frame: 1 year post dose

Population: Efficacy analyses were conducted in the Part 2 Efficacy Population.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part 2: 3000 mg/DayNumber of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2)5 Participants
Other Pre-specified

A Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)

Time frame: 1 year post dose

Population: Efficacy analyses were assessed in Part 2 Efficacy Population

ArmMeasureGroupValue (MEDIAN)
Part 2: 3000 mg/DayA Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)Time to First Response29 days
Part 2: 3000 mg/DayA Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)Time to Best Response30 days

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026