Date: 2014-10-30
Type of information: Initiation of preclinical development
phase: 3
Announcement:
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: high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (rising prostate-specific antigen [PSA] level) following definitive local therapy with radical prostatectomy and/or radiation therapy
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On October 30, 2014, Medivation and Astellas announced plans to initiate a global Phase 3 clinical trial that will evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (rising prostate-specific antigen [PSA] level) following definitive local therapy with radical prostatectomy and/or radiation therapy. This trial will determine if enzalutamide can delay the development of metastatic prostate cancer in high-risk men with a rapidly rising PSA. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily. Leuprolide acetate will be given as an injection of 22.5 mg once every 12 weeks for a minimum of 3 doses. All patients will be treated for 37 weeks. Those achieving an undetectable PSA will suspend study drug(s). If the PSA rises again, study drug(s) will be restarted. Study drug treatment will then continue until disease progression.
The Phase 3 randomized, multi-national trial will be conducted at approximately 160 sites and is designed to enroll approximately 1,860 hormone-sensitive, non-metastatic men with biochemical recurrence following prostatectomy and/or radiation therapy that are at high risk for morbidity and mortality from prostate cancer. Patients will be randomized into three separate groups: enzalutamide plus leuprolide acetate, enzalutamide monotherapy, or placebo plus leuprolide acetate. Treatment with enzalutamide monotherapy will be open-label. Treatment with enzalutamide and placebo will be double-blind in combination with open-label leuprolide acetate.
