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: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020821-41-DK
• Lead Sponsor: Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-03
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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: 0
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