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NCT05554328 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial
A Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT05554328 is a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 165 participants, above the 120-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT05554328, a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib 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. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- 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 Kendall - Miami
- University of Miami Sylvester Comprehensive Cancer Center at Sole Mia - North Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
California
- PCR Oncology - Arroyo Grande
- Cedars Sinai Medical Center - Los Angeles
- Saint Joseph Hospital - Orange - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
- Presbyterian Intercommunity Hospital - Whittier
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Kingman Regional Medical Center - Kingman
Hawaii
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
Alaska
- Alaska Women's Cancer Care - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2023-04-25 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05554328
The ClinicalTrials.gov registry entry for NCT05554328 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 120-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (38% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05554328 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05554328 about?
NCT05554328 is a clinical study titled "Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial". This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway...
What is the current status of trial NCT05554328?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2023-04-25. Estimated completion is 2028-10-01.
What conditions does trial NCT05554328 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Endometrial Carcinoma.
What interventions are being tested in trial NCT05554328?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT05554328?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05554328 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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