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NCT03395197 · ClinicalTrials.gov registry record · Phase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
A Phase 3 study of mCRPC, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 1,054
- Enrollment target
- 20
- Study locations
NCT03395197: Active Phase 3 study of mCRPC, sponsored by Pfizer.
NCT03395197 is a Phase 3 study of mCRPC that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 1,054 participants, above the 112-participant average among 3 other mCRPC trials with a reported enrollment target (841% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03395197, a Phase 3 study of mCRPC, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,054 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the
Conditions Studied
Interventions
- DRUG Talazoparib with enzalutamide
- DRUG Placebo with enzalutamide
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- South County Hematology/Oncology - Chula Vista
- Sharp Rees-Stealy - Chula Vista
- Glendale Adventist Medical Center - Glendale
- Marin Cancer Care, Inc. - Greenbrae
- Cancer Center Oncology Medical Group - La Mesa
- Loma Linda University Cancer Center - Records Management Only - Loma Linda
- Loma Linda University Cancer Center - Hematology/Oncology Clinic - Loma Linda
- Loma Linda University Medical Center - Loma Linda
- VA Long Beach Healthcare System - Long Beach
- UCLA Clark Urology Center - Los Angeles
- University of California, Irvine Medical Center - Orange
Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers - Chandler
- Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers - Gilbert
- Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers - Mesa
- Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers - Mesa
- Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers - Scottsdale
- Arizona Urology Specialists - Tucson
- Arizona Urology Specialists - Tucson
Alaska
- Alaska Urological Institute dba Alaska Clinical Research Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,054 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03395197 still lists
NCT03395197 is an interventional study that assigns participants to a tested intervention. Its 1,054 participants enrollment target places it among the larger protocols in the corpus, above the 112-participant average among 3 other mCRPC trials with a reported enrollment target (841% higher).
The record links to 1 condition, with mCRPC appearing as the primary indexed condition, and to 2 interventions - of which Talazoparib with enzalutamide is the first listed.
NCT03395197 names 20 study sites across 3 states, led by California, Arizona, Alaska.
Frequently Asked Questions
What is clinical trial NCT03395197 about?
NCT03395197 is a clinical study titled "Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC". This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
What is the current status of trial NCT03395197?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,054 participants. The study started on 2017-12-18. Estimated completion is 2027-06-30.
What conditions does trial NCT03395197 study?
This clinical trial studies the following conditions: mCRPC.
What interventions are being tested in trial NCT03395197?
The interventions under investigation include: Talazoparib with enzalutamide (DRUG), Placebo with enzalutamide (DRUG).
Who is sponsoring clinical trial NCT03395197?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03395197 being conducted?
This trial has 20 study locations across Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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