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ARTICLE | Clinical News

Cabozantinib: Phase I data

June 2, 2014 7:00 AM UTC

An open-label, dose-escalation U.S. Phase I trial in 21 patients with progressive metastatic CRPC pre- or post-chemotherapy showed that once-daily 20 and 40 mg doses of oral cabozantinib plus Zytiga abiraterone and prednisone were tolerable with no dose-limiting toxicities (DLTs) reported. There were grade 2 adverse events of myalgias, fatigue and deep vein thrombosis (DVT) with the once-daily 60 mg dose of cabozantinib plus Zytiga and prednisone. Due to a preferable tolerability profile over the 60 mg dose of cabozantinib, the 20 and 40 mg cohorts were expanded from 3 to 9 patients each. Cabozantinib plus Zytiga and prednisone reduced prostate-specific antigen ( KLK3; PSA) levels from baseline by >90% in 50% of patients in the 20 mg cabozantinib arm and in 13% of patients in the 40 mg cabozantinib arm. Cabozantinib plus Zytiga and prednisone reduced PSA levels from baseline by >75% in 63% of patients in the 20 mg cabozantinib arm and in 13% of patients in the 40 mg cabozantinib arm. The trial was sponsored by the Dana-Farber Cancer Institute. Data were presented at the American Society of Clinical Oncology meeting in Chicago. The combination is in Phase II testing to treat metastatic CRPC. ...