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NCT02571725 · ClinicalTrials.gov registry record · Phase 1
PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer
A Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by New Mexico Cancer Research Alliance.
- Active
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT02571725 is a Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer that is active but no longer recruiting, run by New Mexico Cancer Research Alliance. The registered enrollment target is 50 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT02571725, a Phase 1 study of Ovarian Cancer and Fallopian Tube Cancer, is active but no longer recruiting, sponsored by New Mexico Cancer Research Alliance.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
Study Summary
Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair double-stranded breaks in DNA. Treating these tumors with poly(adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitors results in the specific killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of ovarian cancer patients with PARP inhibitors has resulted in improved progression free survival (PFS), but not overall survival (OS). It's not completely understood why this is the case, but some preclinical studies using ovarian cancer models in mice have suggested that combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors improves long-term survival. Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Tremelimumab
Study Locations (5)
New Mexico
- Southwest Gynecologic Oncology Associates - Albuquerque
- University of New Mexico Comprehensive Cancer Center - Albuquerque
Florida
- Moffitt Cancer Center - Tampa
Ohio
- The Ohio State University - Columbus
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-02-23 |
| Est. Completion | 2027-07-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02571725
The ClinicalTrials.gov registry entry for NCT02571725 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (93% lower). The listed sponsor is New Mexico Cancer Research Alliance, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT02571725 reports 5 study locations spanning 4 distinct geographic areas - top geographies include New Mexico, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT02571725 about?
NCT02571725 is a clinical study titled "PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer". Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair d...
What is the current status of trial NCT02571725?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-02-23. Estimated completion is 2027-07-15.
What conditions does trial NCT02571725 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms.
What interventions are being tested in trial NCT02571725?
The interventions under investigation include: Olaparib (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT02571725?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02571725 being conducted?
This trial has 5 study locations across Florida, New Mexico, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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