Trials / Completed
CompletedNCT00974311
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,199 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzalutamide | MDV3100, 160 mg orally per day |
| DRUG | Placebo | Placebo comparator |
Timeline
- Start date
- 2009-09-30
- Primary completion
- 2011-09-15
- Completion
- 2017-11-02
- First posted
- 2009-09-10
- Last updated
- 2018-12-11
- Results posted
- 2012-10-30
Locations
249 sites across 15 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00974311. Inclusion in this directory is not an endorsement.