PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy - PREVAI

Medivation, Inc.0 个研究点目标入组 1,717 人开始时间: 2010年10月12日最近更新: 2019年11月25日

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•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

•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.

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