Prostate Cancer
Conditions
Keywords
CRPC, Prostate Cancer, Bone metastasis, Advanced Castration-Resistant Prostate Cancer (CRPC)
Brief summary
The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC. Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects.
Interventions
DRUGPLX3397
Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.
Sponsors
Plexxikon
Daiichi Sankyo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed prostate cancer, currently with objective progressive disease. * Castrate level of testosterone (\<50 ng/dL). * Baseline circulating tumor cell (CTC) count ≥10/7.5 mL blood. * Archival tumor tissue (unstained sections, paraffin block, or frozen tumor tissue) has been requisitioned for shipment to the central laboratory. * Karnofsky performance status of 80-100. * Adequate organ and marrow function.
Exclusion criteria
* The subject has received: * Any systemic chemotherapy (including investigational agents) within 4 weeks (with the exception of nitrosoureas/mitomycin C within 6 weeks), of the first dose of study treatment, OR * Biological agents (antibodies, immune modulators, cytokines, or vaccines) within 6 weeks of the first dose of study treatment, OR * Hormonal anticancer therapy (not including LHRH agonists or antagonists) within 2 weeks before the first dose of study treatment. Specific restrictions on prior hormonal and other anticancer treatments are detailed in inclusion criterion, OR * Small-molecular kinase inhibitors or any other type of investigational agent within 4 weeks before the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is shorter. * The subject has received drugs used to control loss of bone mass (e.g., bisphosphonates) within 4 weeks prior to the first dose of study treatment. * The subject has symptomatic or uncontrolled brain metastasis or epidural disease requiring current treatment including steroids and anti-convulsants. * The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \>450 ms at screening. * The subject has uncontrolled or significant intercurrent illness including, but not limited to, the following conditions: * Cardiovascular disorders such as symptomatic congestive heart failure (CHF), \*Uncontrolled hypertension * Unstable angina pectoris, clinically-significant cardiac arrhythmias * History of stroke (including transient ischemic attack \[TIA\] or other ischemic event) within 6 months of study treatment * Myocardial infarction within 6 months of study treatment * History of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells | See measure description for time frame. | Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay) CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up. Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication was to continue until the progression had been confirmed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Assessed from first dose through at least 4 weeks after the last dose. | — |
| Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Assessed from first dose through at least 4 weeks after the last dose. | Adverse events (AEs) were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0, where 1=mild, 2=moderate, 3=severe, 4=life-threatening, and 5=death related to AE. |
Countries
United States
Participant flow
Recruitment details
A total of 6 participants received study drug at 2 clinic sites.
Pre-assignment details
A total of 20 participants were planned to be enrolled at approximately 2 to 4 clinic sites.
Participants by arm
| Arm | Count |
|---|---|
| PLX3397 Participants who received a daily oral dose of PLX3397 for 28 day cycles and continued on therapy until disease progression or toxicity. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Progressive disease (clinical) | 1 |
| Overall Study | Progressive disease (radiographic) | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | PLX3397 |
|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 7.24 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 2 / 6 |
Outcome results
Primary
Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells
Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay) CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up. Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication was to continue until the progression had been confirmed.
Time frame: See measure description for time frame.
Population: The study was discontinued and the primary outcome measure was not evaluated. Consequently, no efficacy was evaluated and only safety results are reported. Raw data collected but no efficacy analysis was performed/reported.
Secondary
Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade
Adverse events (AEs) were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0, where 1=mild, 2=moderate, 3=severe, 4=life-threatening, and 5=death related to AE.
Time frame: Assessed from first dose through at least 4 weeks after the last dose.
Population: Adverse events were assessed in the Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Peripheral sensory neuropathy | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Mucosal inflammation | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Diarrhoea | 2 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fall | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Lipase increased | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain in extremity | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pyrexia | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Constipation | 2 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Thrombocytopenia | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nocturia | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Musculoskeletal pain | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nausea | 4 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pneumonia | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | AST increased | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Decreased appetite | 3 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema peripheral | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | ALT increased | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Anaemia | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Spinal cord disorder | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood sodium increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain | 2 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fatigue | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pollakiuria | 2 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood CPK increased | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood glucose increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Influenza | 0 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Dyspnoea | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Urinary retention | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Urinary retention | 1 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pneumonia | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood CPK increased | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fall | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Constipation | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | AST increased | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | ALT increased | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Diarrhoea | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Anaemia | 1 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nocturia | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nausea | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Dyspnoea | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Spinal cord disorder | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fatigue | 2 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Peripheral sensory neuropathy | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Mucosal inflammation | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pollakiuria | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain in extremity | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pyrexia | 1 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Musculoskeletal pain | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Thrombocytopenia | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Decreased appetite | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema peripheral | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood sodium increased | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood glucose increased | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Influenza | 0 Participants |
| NCI CTCAE Grade 2 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Lipase increased | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Constipation | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Anaemia | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Thrombocytopenia | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Diarrhoea | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nausea | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fatigue | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Mucosal inflammation | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pyrexia | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema peripheral | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Influenza | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pneumonia | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fall | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | ALT increased | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | AST increased | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood CPK increased | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Lipase increased | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood glucose increased | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood sodium increased | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Decreased appetite | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Musculoskeletal pain | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain in extremity | 1 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Peripheral sensory neuropathy | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Spinal cord disorder | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nocturia | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Urinary retention | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pollakiuria | 0 Participants |
| NCI CTCAE Grade 3 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Dyspnoea | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Urinary retention | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Lipase increased | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood glucose increased | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema peripheral | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Thrombocytopenia | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood sodium increased | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Decreased appetite | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pyrexia | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Dyspnoea | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Musculoskeletal pain | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Mucosal inflammation | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pollakiuria | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain in extremity | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fatigue | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Peripheral sensory neuropathy | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nausea | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Anaemia | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Spinal cord disorder | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Diarrhoea | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Constipation | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nocturia | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | ALT increased | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fall | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | AST increased | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pneumonia | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood CPK increased | 0 Participants |
| NCI CTCAE Grade 4 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Influenza | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood CPK increased | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pollakiuria | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Lipase increased | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | ALT increased | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Urinary retention | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Peripheral sensory neuropathy | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood glucose increased | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema peripheral | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nausea | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fall | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Dyspnoea | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Blood sodium increased | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Oedema | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Thrombocytopenia | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Anaemia | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Spinal cord disorder | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Decreased appetite | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pyrexia | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Diarrhoea | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Influenza | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | AST increased | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Musculoskeletal pain | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Mucosal inflammation | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pneumonia | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Nocturia | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Constipation | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Pain in extremity | 0 Participants |
| NCI CTCAE Grade 5 | Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade | Fatigue | 0 Participants |
Secondary
Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term
Time frame: Assessed from first dose through at least 4 weeks after the last dose.
Population: Adverse events were assessed in the Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Anaemia | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Thrombocytopenia | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Constipation | 2 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Diarrhoea | 2 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Nausea | 4 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Fatigue | 3 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Mucosal inflammation | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Alanine aminotransferase increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Aspartate aminotransferase increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Blood creatinine phosphokinase increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Blood glucose increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Blood sodium increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Lipase increased | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Decreased appetite | 3 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Pain in extremity | 1 Participants |
| PLX3397 | Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term | Dyspnoea | 1 Participants |