Acute Myeloid Leukemia
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2) | 1 year post dose | 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. |
| 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 dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2) | 1 year post dose | 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%. |
| 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 dose | Data 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 dose | Data 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 dose | 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. |
Other
| Measure | Time 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
| Arm | Count |
|---|---|
| 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 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 4 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5 |
| Overall Study | Disease progression | 3 | 5 | 3 | 2 | 2 | 2 | 3 | 2 | 33 |
| Overall Study | Hematopoietic stem cell transplant | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Non-compliance | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
Baseline characteristics
| Characteristic | Part 1: 800 mg/Day | Total | Part 2: 3000 mg/Day | Part 1: 5000 mg/Day | Part 1: 4000 mg/Day | Part 1: 3000 mg/Day | Part 1: 2000 mg/Day | Part 1: 1400 mg/Day | Part 1: 1200 mg/Day | Part 1: 1000 mg/Day |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.0 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 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 14 Participants | 7 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 15 Participants | 11 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 56 Participants | 35 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 90 participants | 56 participants | 4 participants | 5 participants | 6 participants | 3 participants | 3 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 44 Participants | 23 Participants | 3 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 46 Participants | 33 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 5 | 1 / 4 | 5 / 56 |
| other Total, other adverse events | 3 / 3 | 7 / 7 | 3 / 3 | 3 / 3 | 3 / 3 | 6 / 6 | 5 / 5 | 4 / 4 | 56 / 56 |
| serious Total, serious adverse events | 1 / 3 | 5 / 7 | 2 / 3 | 1 / 3 | 2 / 3 | 5 / 6 | 4 / 5 | 4 / 4 | 39 / 56 |
Outcome results
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: 3000 mg/Day | 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). | CRp | 1 Participants |
| Part 2: 3000 mg/Day | 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). | NR | 45 Participants |
| Part 2: 3000 mg/Day | 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). | Successful BTT patient (CR, CRp, or CRi) | 8 Participants |
| Part 2: 3000 mg/Day | 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). | CR | 1 Participants |
| Part 2: 3000 mg/Day | 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). | CRi | 4 Participants |
| Part 2: 3000 mg/Day | 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). | PR | 5 Participants |
| Part 2: 3000 mg/Day | 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). | Successful BTT patients | 4 Participants |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 2: 3000 mg/Day | Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2) | Duration of remission | 91 days |
| Part 2: 3000 mg/Day | Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2) | Duration of complete remission | 289 days |
| Part 2: 3000 mg/Day | Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2) | Progression-free survival | 48 days |
| Part 2: 3000 mg/Day | Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2) | Disease-free survival | 289 days |
| Part 2: 3000 mg/Day | Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2) | Overall survival | 112 days |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: 3000 mg/Day | Number 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 drug | 0 Participants |
| Part 2: 3000 mg/Day | Number 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 administration | 0 Participants |
| Part 2: 3000 mg/Day | Number 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 AE | 1 Participants |
| Part 2: 3000 mg/Day | Number 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 >=3 | 3 Participants |
| Part 2: 3000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 2: 3000 mg/Day | Number 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 | 3 Participants |
| Part 2: 3000 mg/Day | Number 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 AE | 2 Participants |
| Part 2: 3000 mg/Day | Number 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 Event | 0 Participants |
| Part 1: 1000 mg/Day | Number 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 >=3 | 7 Participants |
| Part 1: 1000 mg/Day | Number 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 Event | 2 Participants |
| Part 1: 1000 mg/Day | Number 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 | 7 Participants |
| Part 1: 1000 mg/Day | Number 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 drug | 2 Participants |
| Part 1: 1000 mg/Day | Number 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 administration | 4 Participants |
| Part 1: 1000 mg/Day | Number 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 AE | 4 Participants |
| Part 1: 1000 mg/Day | Number 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 AE | 5 Participants |
| Part 1: 1000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 1: 1200 mg/Day | Number 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 Event | 0 Participants |
| Part 1: 1200 mg/Day | Number 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 AE | 2 Participants |
| Part 1: 1200 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 1: 1200 mg/Day | Number 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 AE | 3 Participants |
| Part 1: 1200 mg/Day | Number 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 administration | 2 Participants |
| Part 1: 1200 mg/Day | Number 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 drug | 0 Participants |
| Part 1: 1200 mg/Day | Number 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 | 3 Participants |
| Part 1: 1200 mg/Day | Number 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 >=3 | 2 Participants |
| Part 1: 1400 mg/Day | Number 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 drug | 0 Participants |
| Part 1: 1400 mg/Day | Number 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 AE | 3 Participants |
| Part 1: 1400 mg/Day | Number 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 AE | 1 Participants |
| Part 1: 1400 mg/Day | Number 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 >=3 | 3 Participants |
| Part 1: 1400 mg/Day | Number 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 Event | 1 Participants |
| Part 1: 1400 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 1: 1400 mg/Day | Number 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 administration | 1 Participants |
| Part 1: 1400 mg/Day | Number 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 | 3 Participants |
| Part 1: 2000 mg/Day | Number 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 AE | 2 Participants |
| Part 1: 2000 mg/Day | Number 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 drug | 0 Participants |
| Part 1: 2000 mg/Day | Number 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 AE | 3 Participants |
| Part 1: 2000 mg/Day | Number 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 administration | 2 Participants |
| Part 1: 2000 mg/Day | Number 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 >=3 | 2 Participants |
| Part 1: 2000 mg/Day | Number 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 | 3 Participants |
| Part 1: 2000 mg/Day | Number 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 Event | 1 Participants |
| Part 1: 2000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 1: 3000 mg/Day | Number 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 >=3 | 5 Participants |
| Part 1: 3000 mg/Day | Number 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 drug | 3 Participants |
| Part 1: 3000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 3 Participants |
| Part 1: 3000 mg/Day | Number 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 AE | 4 Participants |
| Part 1: 3000 mg/Day | Number 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 Event | 1 Participants |
| Part 1: 3000 mg/Day | Number 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 | 6 Participants |
| Part 1: 3000 mg/Day | Number 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 administration | 5 Participants |
| Part 1: 3000 mg/Day | Number 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 AE | 5 Participants |
| Part 1: 4000 mg/Day | Number 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 Event | 0 Participants |
| Part 1: 4000 mg/Day | Number 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 drug | 2 Participants |
| Part 1: 4000 mg/Day | Number 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 | 5 Participants |
| Part 1: 4000 mg/Day | Number 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 AE | 4 Participants |
| Part 1: 4000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 1: 4000 mg/Day | Number 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 AE | 4 Participants |
| Part 1: 4000 mg/Day | Number 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 >=3 | 5 Participants |
| Part 1: 4000 mg/Day | Number 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 administration | 4 Participants |
| Part 1: 5000 mg/Day | Number 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 administration | 3 Participants |
| Part 1: 5000 mg/Day | Number 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 AE | 4 Participants |
| Part 1: 5000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 0 Participants |
| Part 1: 5000 mg/Day | Number 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 AE | 4 Participants |
| Part 1: 5000 mg/Day | Number 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 Event | 1 Participants |
| Part 1: 5000 mg/Day | Number 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 | 4 Participants |
| Part 1: 5000 mg/Day | Number 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 drug | 0 Participants |
| Part 1: 5000 mg/Day | Number 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 >=3 | 4 Participants |
| Part 2: 3000 mg/Day | Number 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 drug | 9 Participants |
| Part 2: 3000 mg/Day | Number 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 | 56 Participants |
| Part 2: 3000 mg/Day | Number 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 AE | 49 Participants |
| Part 2: 3000 mg/Day | Number 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 administration | 28 Participants |
| Part 2: 3000 mg/Day | Number 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 >=3 | 50 Participants |
| Part 2: 3000 mg/Day | Number 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 AE | 39 Participants |
| Part 2: 3000 mg/Day | Number 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 Event | 10 Participants |
| Part 2: 3000 mg/Day | Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion) | AE resulting in death | 9 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: 3000 mg/Day | 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) | Decreased appetite | 1 Participants |
| Part 2: 3000 mg/Day | 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) | At least 1 treatment-related AE | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Dysgeusia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Nausea | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Diarrhoea | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Vomiting | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Fatigue | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Decreased appetite | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Vomiting | 2 Participants |
| Part 1: 1000 mg/Day | 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) | At least 1 treatment-related AE | 4 Participants |
| Part 1: 1000 mg/Day | 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) | Dysgeusia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Nausea | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Diarrhoea | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Decreased appetite | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Diarrhoea | 1 Participants |
| Part 1: 1200 mg/Day | 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) | At least 1 treatment-related AE | 3 Participants |
| Part 1: 1200 mg/Day | 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) | Nausea | 2 Participants |
| Part 1: 1200 mg/Day | 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) | Dysgeusia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Vomiting | 1 Participants |
| Part 1: 1400 mg/Day | 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) | At least 1 treatment-related AE | 3 Participants |
| Part 1: 1400 mg/Day | 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) | Nausea | 3 Participants |
| Part 1: 1400 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Decreased appetite | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Diarrhoea | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Vomiting | 2 Participants |
| Part 1: 1400 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Dysgeusia | 2 Participants |
| Part 1: 2000 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 2000 mg/Day | 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) | At least 1 treatment-related AE | 3 Participants |
| Part 1: 2000 mg/Day | 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) | Nausea | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Diarrhoea | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Vomiting | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Decreased appetite | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Dysgeusia | 2 Participants |
| Part 1: 3000 mg/Day | 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) | At least 1 treatment-related AE | 4 Participants |
| Part 1: 3000 mg/Day | 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) | Vomiting | 2 Participants |
| Part 1: 3000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Diarrhoea | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Fatigue | 2 Participants |
| Part 1: 3000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Decreased appetite | 2 Participants |
| Part 1: 3000 mg/Day | 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) | Nausea | 2 Participants |
| Part 1: 3000 mg/Day | 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) | Dysgeusia | 2 Participants |
| Part 1: 4000 mg/Day | 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) | Dysgeusia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | At least 1 treatment-related AE | 4 Participants |
| Part 1: 4000 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Vomiting | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Diarrhoea | 3 Participants |
| Part 1: 4000 mg/Day | 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) | Decreased appetite | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Nausea | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Vomiting | 3 Participants |
| Part 1: 5000 mg/Day | 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) | Nausea | 3 Participants |
| Part 1: 5000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Fatigue | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Dysgeusia | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Decreased appetite | 1 Participants |
| Part 1: 5000 mg/Day | 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) | At least 1 treatment-related AE | 4 Participants |
| Part 1: 5000 mg/Day | 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) | Anaemia | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Diarrhoea | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Fatigue | 18 Participants |
| Part 2: 3000 mg/Day | 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) | Decreased appetite | 16 Participants |
| Part 2: 3000 mg/Day | 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) | Diarrhoea | 19 Participants |
| Part 2: 3000 mg/Day | 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) | Anaemia | 9 Participants |
| Part 2: 3000 mg/Day | 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) | Nausea | 21 Participants |
| Part 2: 3000 mg/Day | 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) | Aspartate aminotransferase increased | 10 Participants |
| Part 2: 3000 mg/Day | 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) | At least 1 treatment-related AE | 49 Participants |
| Part 2: 3000 mg/Day | 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) | Dysgeusia | 6 Participants |
| Part 2: 3000 mg/Day | 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) | Vomiting | 15 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: 3000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 3 Participants |
| Part 2: 3000 mg/Day | 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) | Fatigue | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Febrile neutropenia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Sepsis | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Thrombocytopenia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Fatigue | 0 Participants |
| Part 1: 1000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 7 Participants |
| Part 1: 1000 mg/Day | 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) | Febrile neutropenia | 5 Participants |
| Part 1: 1000 mg/Day | 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) | Sepsis | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Fatigue | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Sepsis | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Febrile neutropenia | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 2 Participants |
| Part 1: 1400 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 3 Participants |
| Part 1: 1400 mg/Day | 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) | Febrile neutropenia | 3 Participants |
| Part 1: 1400 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Sepsis | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Thrombocytopenia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Febrile neutropenia | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Platelet count decreased | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Sepsis | 0 Participants |
| Part 1: 2000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 2 Participants |
| Part 1: 2000 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Febrile neutropenia | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Sepsis | 1 Participants |
| Part 1: 3000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 5 Participants |
| Part 1: 4000 mg/Day | 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) | Sepsis | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Anaemia | 2 Participants |
| Part 1: 4000 mg/Day | 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) | Platelet count decreased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Febrile neutropenia | 2 Participants |
| Part 1: 4000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 5 Participants |
| Part 1: 4000 mg/Day | 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) | Fatigue | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 4 Participants |
| Part 1: 5000 mg/Day | 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) | Febrile neutropenia | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Thrombocytopenia | 3 Participants |
| Part 1: 5000 mg/Day | 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) | Sepsis | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Fatigue | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Platelet count decreased | 10 Participants |
| Part 2: 3000 mg/Day | 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) | Fatigue | 3 Participants |
| Part 2: 3000 mg/Day | 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) | Sepsis | 10 Participants |
| Part 2: 3000 mg/Day | 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) | At least 1 AE with CTCAE Grade ≥3 | 50 Participants |
| Part 2: 3000 mg/Day | 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) | Thrombocytopenia | 7 Participants |
| Part 2: 3000 mg/Day | 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) | Febrile neutropenia | 22 Participants |
| Part 2: 3000 mg/Day | 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) | Anaemia | 9 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: 3000 mg/Day | 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) | Hypokalaemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hypomagnesmia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperbilirubinaemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | INR increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Transaminases increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hypocalcaemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Alanine aminotransferase increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Leukocytosis | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hyponatraemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood bilirubin increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hypophosphataemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood alkaline phosphatase increase | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperkalaemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Neutropenia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 2: 3000 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperglycaemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Transaminases increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hypophosphataemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hyponatraemia | 2 Participants |
| Part 1: 1000 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Myeloblast count increased | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Blood bilirubin increased | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Alanine aminotransferase increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Hypokalaemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Thrombocytopenia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Hyperbilirubinaemia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hypomagnesmia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hypocalcaemia | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | INR increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Leukocytosis | 1 Participants |
| Part 1: 1000 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hyperglycaemia | 2 Participants |
| Part 1: 1000 mg/Day | 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) | Blood alkaline phosphatase increase | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Neutropenia | 0 Participants |
| Part 1: 1000 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 1: 1000 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hypokalaemia | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hypomagnesmia | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Hypocalcaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood alkaline phosphatase increase | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyperglycaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyponatraemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Alanine aminotransferase increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood bilirubin increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hypophosphataemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Transaminases increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Neutropenia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Leukocytosis | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | INR increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyperbilirubinaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1200 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 1200 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Transaminases increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Alanine aminotransferase increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood bilirubin increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | INR increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hypokalaemia | 2 Participants |
| Part 1: 1400 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hyponatraemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Leukocytosis | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hypophosphataemia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Hyperglycaemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood alkaline phosphatase increase | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hypocalcaemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Neutropenia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hypomagnesmia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hyperbilirubinaemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Thrombocytopenia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 1400 mg/Day | 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) | Aspartate aminotransferase increased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 1: 1400 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Anaemia | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hypokalaemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hypocalcaemia | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Neutropenia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Platelet count decreased | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Alanine aminotransferase increased | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hypomagnesmia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood bilirubin increased | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | INR increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Aspartate aminotransferase increased | 2 Participants |
| Part 1: 2000 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hyponatraemia | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Hyperbilirubinaemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Blood alkaline phosphatase increase | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Transaminases increased | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Hypophosphataemia | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Leukocytosis | 0 Participants |
| Part 1: 2000 mg/Day | 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) | Hyperglycaemia | 1 Participants |
| Part 1: 2000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Thrombocytopenia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Transaminases increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood alkaline phosphatase increase | 0 Participants |
| Part 1: 3000 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Neutropenia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | INR increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyperphosphataemia | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Hypocalcaemia | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Leukocytosis | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hypomagnesmia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyperbilirubinaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hypokalaemia | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Anaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Alanine aminotransferase increased | 1 Participants |
| Part 1: 3000 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Blood bilirubin increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyponatraemia | 2 Participants |
| Part 1: 3000 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hyperglycaemia | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 3000 mg/Day | 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) | Hypophosphataemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hypoalbuminaemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hypophosphataemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Transaminases increased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Anaemia | 2 Participants |
| Part 1: 4000 mg/Day | 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) | Hypokalaemia | 2 Participants |
| Part 1: 4000 mg/Day | 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) | Thrombocytopenia | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Hypomagnesmia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hypocalcaemia | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Platelet count decreased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Blood alkaline phosphatase increase | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Hyperglycaemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hyponatraemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Alanine aminotransferase increased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Blood bilirubin increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | White blood cell count decreased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Neutropenia | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Neutrophil count decreased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Leukocytosis | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hyperbilirubinaemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 4000 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | INR increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 4000 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Thrombocytopenia | 3 Participants |
| Part 1: 5000 mg/Day | 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) | Bilirubin conjugated increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hyperkalaemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hyperchloraemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hypernatraemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Leukopenia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood uric acid increased | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Blood urea decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Gamma glutamyl transferase increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hyperuricaemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hyperbilirubinaemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hypophosphataemia | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Globulins increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood cholesterol increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Leukocytosis | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Neutrophil count decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hypoalbuminaemia | 1 Participants |
| Part 1: 5000 mg/Day | 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) | INR increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Lymphocyte count decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Neutropenia | 2 Participants |
| Part 1: 5000 mg/Day | 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) | White blood cell count decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Lipase increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood bilirubin increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Alanine aminotransferase increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Hyponatraemia | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Hyperglycaemia | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood alkaline phosphatase increase | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Platelet count decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hypocalcaemia | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Troponin increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hypomagnesmia | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Hypokalaemia | 2 Participants |
| Part 1: 5000 mg/Day | 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) | Aspartate aminotransferase increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | White blood cell count increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Anaemia | 3 Participants |
| Part 1: 5000 mg/Day | 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) | Transaminases increased | 1 Participants |
| Part 1: 5000 mg/Day | 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) | Blood creatinine phosphokinase increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood chloride increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood albumin decreased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blast cell count increased | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 1: 5000 mg/Day | 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) | Blood fibrinogen decreased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Lipase increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Blood bilirubin increased | 7 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperkalaemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Hypophosphataemia | 7 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperchloraemia | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Alanine aminotransferase increased | 6 Participants |
| Part 2: 3000 mg/Day | 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) | Leukopenia | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Bilirubin conjugated increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Hyponatraemia | 5 Participants |
| Part 2: 3000 mg/Day | 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) | Carbon monoxide diffusing capacity decreased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Blood creatinine phosphokinase increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Blood uric acid increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | White blood cell count increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood urea decreased | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Anaemia | 15 Participants |
| Part 2: 3000 mg/Day | 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) | Activated partial thromboplastin time prolonged | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Hypernatraemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Myeloblast count increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Gamma glutamyl transferase increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Blood alkaline phosphatase increase | 10 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperuricaemia | 3 Participants |
| Part 2: 3000 mg/Day | 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) | Blast cell count increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperbilirubinaemia | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Platelet count decreased | 12 Participants |
| Part 2: 3000 mg/Day | 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) | Blood cholesterol increased | 3 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperphosphataemia | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Hypocalcaemia | 8 Participants |
| Part 2: 3000 mg/Day | 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) | Globulins increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Transaminases increased | 5 Participants |
| Part 2: 3000 mg/Day | 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) | Leukocytosis | 2 Participants |
| Part 2: 3000 mg/Day | 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) | Aspartate aminotransferase increased | 13 Participants |
| Part 2: 3000 mg/Day | 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) | Neutrophil count decreased | 6 Participants |
| Part 2: 3000 mg/Day | 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) | Blood albumin decreased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Lymphocyte count decreased | 7 Participants |
| Part 2: 3000 mg/Day | 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) | Troponin increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Hypomagnesmia | 10 Participants |
| Part 2: 3000 mg/Day | 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) | INR increased | 0 Participants |
| Part 2: 3000 mg/Day | 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) | Blood chloride increased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Neutropenia | 4 Participants |
| Part 2: 3000 mg/Day | 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) | Thrombocytopenia | 9 Participants |
| Part 2: 3000 mg/Day | 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) | White blood cell count decreased | 7 Participants |
| Part 2: 3000 mg/Day | 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) | Blood fibrinogen decreased | 1 Participants |
| Part 2: 3000 mg/Day | 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) | Hypoalbuminaemia | 8 Participants |
| Part 2: 3000 mg/Day | 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) | Hyperglycaemia | 9 Participants |
| Part 2: 3000 mg/Day | 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) | Hypokalaemia | 13 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 2: 3000 mg/Day | Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2) | CR | 2 Participants |
| Part 2: 3000 mg/Day | Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2) | CRi | 6 Participants |
| Part 2: 3000 mg/Day | Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2) | PR | 2 Participants |
| Part 2: 3000 mg/Day | Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2) | NR | 46 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 2: 3000 mg/Day | Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2) | 5 Participants |
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 2: 3000 mg/Day | 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 to First Response | 29 days |
| Part 2: 3000 mg/Day | 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 to Best Response | 30 days |