Safety, Phase I, Patients Primary 140 with analysis MTD, uncontrolled, metastatic PK, dose-escalation CRPC efficacy and cohorts PK, Phase Ib, Patients Primary 22 safety, with analysis metastatic CRPC Efficacy, Phase II, Patients 1-year 67 safety, single arm with analysis PD, PK prostate cancer Pivotal efficacy study MDV3100-03 (PREVAIL) – The safety population was defined as: All patients randomly assigned to treatment who received at least 1 dose or partial dose of study drug (enzalutamide or placebo). In PREVAIL, the sponsor reports the following safety data were collected: adverse events (AEs) were assessed by the frequency of adverse events, grade 3 or “General higher adverse events, serious adverse events, adverse events that were the primary reason for discontinuation of study drug, adverse events associated with discontinuation of study drug, adverse events leading to dose modification, and deaths, as well as the frequency of new clinically significant changes in physical examination findings, vital signs, laboratory values, and ECGs.” Non-pivotal efficacy studies Studies 9785-CL-0111 and 9785-CL-0321 provided data on safety. Patient exposure In PREVAIL, treatment duration for the interim analysis was calculated up to the data analysis cut-off date for patients receiving ongoing therapy. Patients were required to return any unused medicines; it was assumed that non-returned medicine was The exposure of patients in PREVAIL is shown in Table 20. Table 20: Exposure to enzalutamide & placebo, PREVAIL. Dose modifications were permitted in the study, with 11.8% and 10.0% of the enzalutamide and placebo arms having at least one dose modification, respectively.
Safety, MTD, PK, efficacy Phase I, uncontrolled, dose-escalation and cohorts Patients with metastatic CRPC Primary analysis 140 PK, safety, Phase Ib, Patients with metastatic CRPC Primary analysis 22 Efficacy, safety, PD, PK Phase II, single arm Patients with prostate cancer 1-year analysis 67 Pivotal efficacy study – MDV3100-03 (PREVAIL) The safety population was defined as: All patients randomly assigned to treatment who received at least 1 dose or partial dose of study drug (enzalutamide or placebo). In PREVAIL, the sponsor reports the following safety data were collected: “General adverse events (AEs) were assessed by the frequency of adverse events, grade 3 or higher adverse events, serious adverse events, adverse events that were the primary reason for discontinuation of study drug, adverse events associated with discontinuation of study drug, adverse events leading to dose modification, and deaths, as well as the frequency of new clinically significant changes in physical examination findings, vital signs, laboratory values, and ECGs.” Non-pivotal efficacy studies Studies 9785-CL-0111 and 9785-CL-0321 provided data on safety. Patient exposure In PREVAIL, treatment duration for the interim analysis was calculated up to the data analysis cut-off date for patients receiving ongoing therapy. Patients were required to return any unused medicines; it was assumed that non-returned medicine was The exposure of patients in PREVAIL is shown in Table 20. Table 20: Exposure to enzalutamide & placebo, PREVAIL. Dose modifications were permitted in the study, with 11.8% and 10.0% of the enzalutamide and placebo arms having at least one dose modification, respectively.
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