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Trials & Filings

Exelixis Begins CRPC Trial

Ph II trial tests combos with different doses

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Exelixis has begun a Phase II clinical trial comparing cabozantinib plus abiraterone and prednisone (abiraterone/prednisone) versus abiraterone/prednisone in patients with castration-resistant prostate cancer (CRPC) who have bone metastases and have not been previously treated with chemotherapy. The primary endpoint for the randomized, open-label trial is radiographic progression-free survival (PFS).

The trial will compare abiraterone/prednisone against abiraterone/prednisone in combination with one of the three cabozantinib doses: 40 mg daily, 20 mg daily, or 20 mg every other day. The trial is expected to enroll 280 chemotherapy-naïve CRPC patients who have bone metastases, and will be conducted at approximately 50 sites in North America. In addition to evaluating radiographic PFS, the trial includes pre-specified outcome measures of safety and tolerability, pharmacokinetics of cabozantinib in combination with abiraterone, overall survival (OS), and bone scan response by computer-aided detection.

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