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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,717 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Enzalutamide

Trial Details

FieldValue
Enrollment Target 1,717 participants
Start Date 2010-09-16
Est. Completion 2019-02-14
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01212991

The ClinicalTrials.gov registry entry for NCT01212991 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,717 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01212991 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.