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NCT04633239 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
A Phase 1 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Ovarian High Grade Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT04633239: Recruiting Phase 1 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Ovarian High Grade Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT04633239 is a Phase 1 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Ovarian High Grade Serous Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, above the 35-participant average among 5 other Recurrent Platinum-Resistant Ovarian Carcinoma trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04633239, a Phase 1 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Ovarian High Grade Serous Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.
Primary Outcome
Safety and tolerability will be measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The number of patients experiencing a dose limiting toxicity will be tabulated. The recommended phase 2 dose will be determined by the dose escalation phase using 3+3 design.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Olaparib
- DRUG Abemaciclib
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- Mayo Clinic in Florida - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Missouri
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital - North Kansas City
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Illinois
- Northwestern University - Chicago
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 1 |
What NCT04633239 shows while recruiting
NCT04633239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, above the 35-participant average among 5 other Recurrent Platinum-Resistant Ovarian Carcinoma trials with a reported enrollment target (20% higher).
The record links to 2 conditions, with Recurrent Platinum-Resistant Ovarian Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04633239 names 20 study sites across 7 states, led by Florida, Kansas, California.
Frequently Asked Questions
What is clinical trial NCT04633239 about?
NCT04633239 is a clinical study titled "Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer". This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-res...
What is the current status of trial NCT04633239?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-07-02. Estimated completion is 2026-11-01.
What conditions does trial NCT04633239 study?
This clinical trial studies the following conditions: Recurrent Platinum-Resistant Ovarian Carcinoma, Recurrent Ovarian High Grade Serous Adenocarcinoma.
What interventions are being tested in trial NCT04633239?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Olaparib (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04633239?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04633239 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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