FDA green-lights U.S. patient enrollment in masitinib Phase 3 study following IND clearance in metastatic castrate-resistant prostate cancer eligible to chemotherapy
AB SCIENCE today announces that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to conduct its masitinib Phase 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy.
Study AB12003 is an international, multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer (mCRPC) eligible to chemotherapy. The study aims to compare the efficacy and safety of masitinib (6.0 mg/kg/day) in combination with docetaxel to placebo in combination with docetaxel. Docetaxel is combined with prednisone. The study primary endpoint is progression free survival (PFS). A total of 468 patients are planned to be enrolled. The target patient population consists of adult males who have progressed to develop metastatic castrate resistant prostate cancer (mCRPC) after castration treatment (i.e. reduction of available androgen/testosterone/DHT by chemical or surgical means) and are therefore eligible for chemotherapy. An interim analysis was performed by the Independent Data Monitoring Committee (IDMC) in June 2018. Based on the rules set for the interim analysis, the recommendation from the IDMC was to continue the study in a pre-specified subgroup of patients that are identified by a biomarker. According to the statistical rule of the protocol at the interim analysis, this means that the probability of success of study AB12003 may exceed 80% in this pre-specified subgroup, assuming that the patients remaining to be enrolled behave similarly to those analyzed at the interim analysis. The subgroup of patients is expected to represent around two-thirds of the population.