Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Prostatic Neoplasms

Neoplastic Cells, Circulating

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants will take daily oral dose of PLX3397 for 28 day cycles. Participants will continue to take PLX3397 until disease progression or toxicity.

Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.

PLX3397

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.

Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)

A Pilot Study of PLX3397 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients With Bone Metastasis and High Circulating Tumor Cell (CTC) Counts

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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.

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.

Plexxikon

Daiichi Sankyo

Adverse events that emerge (or worsen) from after the first dose of study drug and within 28 days after last dose.

Participants who received a daily oral dose of PLX3397 for 28 day cycles and continued on therapy until disease progression or toxicity.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

This study did not meet its planned enrollment goal of 20 participants by the end of 2012. Therefore, enrollment was terminated and efficacy was not evaluated; only the safety results are reported.

Medical Director

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.

Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells

Anaemia

Thrombocytopenia

Constipation

Diarrhoea

Nausea

Fatigue

Mucosal inflammation

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood creatinine phosphokinase increased

Blood glucose increased

Blood sodium increased

Lipase increased

Decreased appetite

Pain in extremity

Dyspnoea

Adverse events were assessed in the Safety Population.

Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term

Pyrexia

Oedema

Oedema peripheral

Pain

Influenza

Pneumonia

Fall

ALT increased

AST increased

Blood CPK increased

Musculoskeletal pain

Peripheral sensory neuropathy

Spinal cord disorder

Nocturia

Urinary retention

Pollakiuria

Participants who received PLX3397 and experienced a Grade 1 treatment-emergent adverse event.

NCI CTCAE Grade 1

Participants who received PLX3397 and experienced a Grade 2 treatment-emergent adverse event.

NCI CTCAE Grade 2

Participants who received PLX3397 and experienced a Grade 3 treatment-emergent adverse event.

NCI CTCAE Grade 3

Participants who received PLX3397 and experienced a Grade 4 treatment-emergent adverse event.

NCI CTCAE Grade 4

Participants who received PLX3397 and experienced a Grade 5 treatment-emergent adverse event.

NCI CTCAE Grade 5

Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade

Overall Study

Spots Global Cancer Trial Database for Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial