Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)
The main objective of this study is to evaluate the effects on the body that PLX3397 on male subjects with CRPC.
Secondary objectives include evaluating the safety and tolerability of PLX3397 and the antitumor effects that PLX3397 has on the the subjects.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of PLX3397 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients With Bone Metastasis and High Circulating Tumor Cell (CTC)Counts|
- Efficacy-Biomarker Profiling [ Time Frame: 1 year ] [ Designated as safety issue: No ]Circulating tumor cells (CTCs) will be measured every 4 weeks.
- Safety-Subject incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Subject incidence of adverse events will be summarized. Adverse events will be tallied for overall frequency, worst reported severity, and relationship to study drug for each preferred term per subject. Serious adverse events will be similarly summarized.
Clinically significant changes in vital signs, ECGs and clinical laboratory tests (hematology and chemistry) will be summarized by changes from baseline to scheduled time points using descriptive statistics.
- Efficacy-Treatment Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects will be monitored for disease progression using the following outcomes:
- Prostate Serum Antigen (PSA). PSA will be measured every 8 weeks
- Soft Tissue Disease. Target lesions will be measured via CT scan every 8 weeks
- Bone Disease. Assessed via radionuclide bone scans and whole body MRIs every 8 weeks.
- Time to Progression (TTP). Measured from start of treatment until progression.
|Study Start Date:||March 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Subjects will take daily oral dose of PLX3397 for 28 day cycles. Subjects will continue to take PLX3397 until disease progression or toxicity.
Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499043
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|