Advanced Prostate Cancer Clinical Trial
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
Although there have been advances in the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC), all patients eventually develop resistance to available therapy. Docetaxel is the accepted first-line agent followed by cabazitaxel in the post-docetaxel phase. In this study the investigators propose to evaluate BKM120, a PI3K inhibitor, with cabazitaxel in the treatment of patients with advanced prostate cancer.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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