Date: 2013-11-12
Type of information: Initiation of the trial
phase: 4
Announcement: initiation of the trial
Company: Medivation (USA - CA) Astellas (Japan)
Product: Xtandi® (enzalutamide)
Action
mechanism: Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. It has been shown to competitively inhibit androgen binding to androgen receptors and inhibit androgen receptor nuclear translocation and interaction with DNA. A major metabolite, N-desmethyl enzalutamide, exhibited similar in vitro activity to Xtandi®. Xtandi® decreased proliferation and induced cell death of prostate cancer cells in vitro, and decreased tumor volume in a mouse prostate cancer xenograft model.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Denmark, Finland, France, Italy, Slovakia, Spain, Sweden, UK, USA
Trial
details: The Phase 4 global randomized, double-blind, placebo-controlled trial is designed to enroll approximately 500 chemotherapy-naïve patients with metastatic castration-resistant prostate cancer. All enrolled patients will initially receive treatment with enzalutamide. Eligible patients with disease progression on enzalutamide will be randomized to treatment with enzalutamide plus abiraterone acetate and prednisone or to abiraterone acetate and prednisone. The primary endpoint of the trial is progression-free survival. The trial will evaluate enzalutamide at a dose of 160 mg taken orally once daily in combination with abiraterone acetate at a dose of 1000 mg administered orally once daily and prednisone at a dose of 5 mg administered orally twice daily, versus placebo plus the same doses of abiraterone acetate and prednisone. (NCT01995513)
Latest
news: * On November 12, 2013, Astellas Pharma and Medivation announced the initiation of a Phase 4 clinical trial, known as PLATO. The study will evaluate the efficacy and safety of continued treatment with enzalutamide plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone in patients with chemotherapy-naïve metastatic prostate cancer whose disease has progressed following enzalutamide therapy.
