Date: 2016-06-02
Type of information: Initiation of development program
phase: 3
Announcement: initiation of development program
Company: Medivation (USA - CA) Astellas (Japan)
Product: Xtandi® (enzalutamide) and paclitaxell
Action
mechanism: androgen receptor inhibitor. 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: triple-negative breast cancer (TNBC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: ENDEAR will be a Phase III, randomized, international trial, enrolling approximately 780 patients with advanced diagnostic-positive TNBC who have received either no or one prior line of systemic therapy for advanced disease. The primary efficacy endpoint is progression-free survival (PFS), defined as the time from randomization to the first evidence of disease progression or death, whichever occurs first. The trial will evaluate enzalutamide at a dose of 160 mg per day taken orally, either with paclitaxel (90 mg/m2) administered intravenously once weekly for 16 weeks (or longer at investigator discretion), or as monotherapy compared to placebo with paclitaxel.
Latest
news: * On June 2, 2016, Medivation and Astellas Pharma announced plans to commence a Phase III clinical trial to investigate the use of enzalutamide for the treatment of triple-negative breast cancer (TNBC). The ENDEAR (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of ENzalutamiDe in Combination With PaclitaxEl Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative BReast Cancer) trial will evaluate the efficacy and safety of enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic TNBC whose tumors test positive for a novel gene expression profile, which is referred to as diagnostic-positive TNBC. The trial, which will be led by Medivation , is expected to begin patient enrollment in the fourth quarter of 2016.
