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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 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.

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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).

Conditions Studied

Metastatic Prostate Cancer

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

FieldValue
Enrollment Target 1,101 participants
Start Date 2017-06-30
Est. Completion 2024-04-24
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03072238

The ClinicalTrials.gov registry entry for NCT03072238 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,101 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 160-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (588% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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

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.