An International Study to Evaluate the Safety and Effectiveness of MDV3100 in Patients with Prostate Cancer Where Their Cancer Has Progressed Despite Hormonal Therapy

Phase 1

Conditions: Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-020821-41-GB

Lead Sponsor: Medivation, Inc., a wholly owned subsidiary of Pfizer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1717

Inclusion Criteria

The inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.
Eligible patients must meet all inclusion criteria.
1. Received randomized double-blind treatment in PREVAIL;
2. Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the
study site;
3. Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH)
agonist/antagonist or has had a bilateral orchiectomy;
4. Is able to swallow enzalutamide capsules whole and to comply with study requirements throughout the
study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1260

Exclusion Criteria

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as
randomized treatment. Each patient must NOT meet any of the following criteria:
1. Is taking commercially available enzalutamide (Xtandi);
2. Has any clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic,
hepatic, infectious, metabolic, neurologic, psychological, pulmonary, or renal disorder or any other
condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with
study participation in the opinion of the investigator or medical monitor;
3. Has current or previously treated brain metastasis or active leptomeningeal disease;
4. Has a history of seizure or a condition that may increase the risk of seizure;
5. Has total bilirubin = 1.5-times the upper limit of normal (ULN) (except patients with a diagnosis of
Gilbert’s disease); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5-times ULN
at screening. For patients with documented liver metastases, ALT and AST exclusion is > 5-times ULN;
6. Has creatinine > 2 mg/dL (177 µmol/L) at screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Co-Primary Objectives:<br>• To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival;<br>• To determine the benefit of MDV3100 as compared to placebo as assessed by radiographic progression-free survival (rPFS).<br>;Secondary Objective: Key Secondary Objectives:<br>•To determine the benefit of MDV3100 as compared to placebo as assessed by time to first skeletal-related event;<br>•To determine the benefit of MDV3100 as compared to placebo as assessed by time to initiation of cytotoxic chemotherapy.<br>;Primary end point(s): Co-primary endpoints:<br>Overall Survival and Radiographic Progression Free Survival;Timepoint(s) of evaluation of this end point: Overall Survival: Time from randomization to death due to any cause will be assessed<br>Radiographic Progression-Free Survival: Time from randomization to the first objective evidence of radiologic progression or death due to any cause (whichever occurs first) will be assessed

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to First Skeletal-Related Event<br>Time to Initiation of Cytotoxic Chemotherapy;Timepoint(s) of evaluation of this end point: Time to First Skeletal-Related Event: Time from randomization to first skeletal-related event will be assessed<br>Time to Initiation of Cytotoxic Chemotherapy: Time from randomization to initiation of cytotoxic chemotherapy will be assessed

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