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)
Conditions
Interventions
Product Name: MDV3100
Product Code: MDV3100
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Enzalutamide
CAS Number: 915087-33-1
Current Sponsor code: MDV3100
Concentration unit: mg milligram(
Sponsors
Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Co-Primary Objectives: • To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival • To determine the benefit of MDV3100 as compared to placebo as assessed by radiographic progression-free survival (rPFS) ;Secondary Objective: Key Secondary Objectives: • To determine the benefit of MDV3100 as compared to placebo as assessed by time to first skeletal-related event • To determine the benefit of MDV3100 as compared to placebo as assessed by time to initiation of cytotoxic chemotherapy;Primary end point(s): Co-primary endpoints: 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 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to First Skeletal-Related Event 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 Time to Initiation of Cytotoxic Chemotherapy: Time from randomization to initiation of cytotoxic chemotherapy will be assessed | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Lithuania, Netherlands, Poland, Russian Federation, Singapore, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactMedical Officer
Medivation Inc
Outcome results
None listed