Clinical efficacy Studies providing efficacy data Table 6 shows efficacy studies. Table 6: Submitted efficacy studies. ID Study type Phase, design Number of population subjects Efficacy & Phase III, 871 safety randomised, naïve PREVAIL double-blind, patients 844 placebo with placebo controlled, metastatic multicentre CRPC PK, safety, Phase Ib, Patients 22 tolerability with metastatic CRPC Efficacy, Phase II, Patients 67 safety, single arm with tolerability, PD, PK prostate cancer Proposed indication Pivotal efficacy studies Study MDV3100-03 (PREVAIL) Study design, objectives, locations and dates This was a phase 3, randomised, double-blind, placebo-controlled multicentre performed in North America, Europe, Australia and Asia to assess the efficacy and safety of enzalutamide in patients with metastatic prostate cancer that progressed on androgen deprivation therapy. Patients must have been asymptomatic or mildly symptomatic due to prostate cancer at study entry and must not have previously received cytotoxic chemotherapy. Inclusion and exclusion criteria Table shows inclusion and exclusion criteria. Table 7: Inclusion and exclusion criteria. Inclusion criteria Exclusion criteria 1. Age 18 or older and willing and able to 1. Severe, concurrent disease, infection, or provide informed consent comorbidity that, in the judgment of the investigator, make the patient 2. Histologically or cytologically confirmed inappropriate for enrolment adenocarcinoma of the prostate without
Clinical efficacy Studies providing efficacy data Table 6 shows efficacy studies. Table 6: Submitted efficacy studies. ID Study type Phase, design population Number of subjects PREVAIL Efficacy & safety Phase III, randomised, double-blind, placebo controlled, multicentre naïve patients with metastatic CRPC 871 844 placebo PK, safety, tolerability Phase Ib, Patients with metastatic CRPC 22 Efficacy, safety, tolerability, PD, PK Phase II, single arm Patients with prostate cancer 67 Proposed indication Pivotal efficacy studies Study MDV3100-03 (PREVAIL) Study design, objectives, locations and dates This was a phase 3, randomised, double-blind, placebo-controlled multicentre performed in North America, Europe, Australia and Asia to assess the efficacy and safety of enzalutamide in patients with metastatic prostate cancer that progressed on androgen deprivation therapy. Patients must have been asymptomatic or mildly symptomatic due to prostate cancer at study entry and must not have previously received cytotoxic chemotherapy. Inclusion and exclusion criteria Table shows inclusion and exclusion criteria. Table 7: Inclusion and exclusion criteria. Inclusion criteria Exclusion criteria 1. Age 18 or older and willing and able to provide informed consent 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without 1. Severe, concurrent disease, infection, or comorbidity that, in the judgment of the investigator, make the patient inappropriate for enrolment
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