Cabazitaxel and BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel
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|ClinicalTrials.gov Identifier: NCT02035124|
Recruitment Status : Withdrawn (Study withdrawn due to slow accrual. No patients were enrolled.)
First Posted : January 14, 2014
Last Update Posted : February 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Advanced Prostate Cancer||Drug: BKM 120 Drug: Cabazitaxel||Phase 2|
This study will be conducted in two parts. In a lead-in cohort, the feasibility and safety of administering BKM120 with a standard dose of cabazitaxel will be assessed. If safety is confirmed, a subsequent Phase II portion will assess the activity of the combination in patients with mCRPC previously treated with docetaxel. The treatment will consist of 3-week (21-day) cycles.
The ultimate purpose of this study will be to determine progression-free survival, response rate, disease control rate and overall survival of patients treated with the combination regimen and compare outcomes to historical results with single-agent cabazitaxel.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cabazitaxel With BKM120 in Patients With Metastatic Castrate-Resistant Prostate Cancer Following Treatment With Docetaxel: Phase II Study With Safety Lead-in Cohort|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: BKM120 and Cabazitaxel
BKM 120 orally once daily;
Cabazitaxel 25 mg/m2 IV every 3 weeks
Drug: BKM 120
Other Name: BKM 120 (Buparlisib)
Other Name: Jevtana
- Number of Subjects with Serious and Non-Serious Adverse Events [ Time Frame: up to 24 months ]Determine the optimal dose and safety of BKM120 given with cabazitaxel to patients with metastatic castrate-resistant prostate cancer.
- Progression Free Survival (PFS) [ Time Frame: every 6 weeks, up to 24 months ]time to disease progression
- Overall Response Rate [ Time Frame: every 6 weeks, up to 24 months ]Percentage of complete responders (CR) or partial responders (PR) among patients evaluable for response
- Overall Survival [ Time Frame: up to 36 months ]Time from first treatment until death from any cause using Kaplan-Meier methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035124
|United States, Florida|
|Florida Cancer Specialists-South|
|Ft. Myers, Florida, United States, 33916|
|United States, Nebraska|
|Nebraska Methodist Hospital|
|Omaha, Nebraska, United States, 68114|
|United States, Tennessee|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||John D. Hainsworth, M.D.||SCRI Development Innovations, LLC|