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NCT01212991 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,717
- Enrollment target
NCT01212991: Completed Phase 3 study, sponsored by Pfizer.
NCT01212991 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,717 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212991, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,717 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
Primary Outcome
Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
Interventions
- DRUG Placebo
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,717 participants |
| Start Date | 2010-09-16 |
| Est. Completion | 2019-02-14 |
| Phase | Phase 3 |
What the finished NCT01212991 record still lists
NCT01212991 is an interventional study that assigns participants to a tested intervention. Its 1,717 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01212991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01212991 about?
NCT01212991 is a clinical study titled "A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer". The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
What is the current status of trial NCT01212991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,717 participants. The study started on 2010-09-16. Estimated completion is 2019-02-14.
What interventions are being tested in trial NCT01212991?
The interventions under investigation include: Placebo (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT01212991?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01212991's enrollment target sits among peer trials
1,717 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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