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NCT03072238 · ClinicalTrials.gov registry record · Phase 3
Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
A Phase 3 study of Metastatic Prostate Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,101
- Enrollment target
- 20
- Study locations
NCT03072238: Completed Phase 3 study of Metastatic Prostate Cancer, sponsored by Hoffmann-La Roche.
NCT03072238 is a Phase 3 study of Metastatic Prostate Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,101 participants, above the 160-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (588% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03072238, a Phase 3 study of Metastatic Prostate Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,101 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
Primary Outcome
rPFS was defined as time from date of randomization to the first occurrence of documented disease progression (PD), as assessed by the investigator with use of the PCWG3 criteria or death from any cause, whichever occurs first. PD for soft tissue was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm) in the SOD of target lesions; progression
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ipatasertib
- DRUG Abiraterone
- DRUG Prednisone/Prednisolone
Study Locations (20)
California
- City of Hope - Duarte
- USC Norris Cancer Center - Los Angeles
- UC Irvine Medical Center - Orange
- Stanford University - Palo Alto
- Pacific Hematology Oncology Associates - San Francisco
Arizona
- Ironwood Cancer & Research Centers - Chandler
- Mayo Clinic Arizona - Scottsdale
Florida
- Lynn Cancer Institute/Boca Raton Regional Hospital - Boca Raton
- Miami Cancer Institute of Baptist Health, Inc. - Miami
Massachusetts
- Tufts Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
- Karmanos Cancer Institute.. - Detroit
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,101 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2024-04-24 |
| Phase | Phase 3 |
What the finished NCT03072238 record still lists
NCT03072238 is an interventional study that assigns participants to a tested intervention. Its 1,101 participants enrollment target places it among the larger protocols in the corpus, above the 160-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (588% higher).
The record links to 1 condition, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03072238 names 20 study sites across 12 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03072238 about?
NCT03072238 is a clinical study titled "Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer". The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
What is the current status of trial NCT03072238?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,101 participants. The study started on 2017-06-30. Estimated completion is 2024-04-24.
What conditions does trial NCT03072238 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer.
What interventions are being tested in trial NCT03072238?
The interventions under investigation include: Placebo (DRUG), Ipatasertib (DRUG), Abiraterone (DRUG), Prednisone/Prednisolone (DRUG).
Who is sponsoring clinical trial NCT03072238?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03072238 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03072238's enrollment target sits among peer trials
1,101 1st of 41 higher than 41 of 41 other Metastatic Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Prostate Cancer 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.
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