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NCT02627443 · ClinicalTrials.gov registry record · Phase 1
Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 14
- Study locations
NCT02627443: Active Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02627443 is a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (72% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02627443, a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and berzosertib when given together with carboplatin in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Chemotherapy drugs, such as carboplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving berzosertib with chemotherapy (carboplatin and gemcitabine hydrochloride) may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer compared to chemotherapy alone.
Primary Outcome
DLT will be defined as grade 4 absolute neutrophil count for ≥ 5 days, grade 4 anemia, platelet count \< 25,000, or other non-hematologic events ≥ grade 3 as per NCI Common Terminology Criteria for Adverse Events Version 4.0 (except fatigue, alopecia and anorexia). The MTD in this study will be defined as the highest safely tolerated dose, up to a maximum of dose level 4, where at most 1 out of six patients experience a DLT with the next higher dose having at least 2 DLTs in 3 or more patients.
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Gemcitabine Hydrochloride
- DRUG Berzosertib
- OTHER Pharmacological Study
Study Locations (14)
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
- Mayo Clinic in Florida - Jacksonville
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Colorado
- UCHealth University of Colorado Hospital - Aurora
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-05-16 |
| Est. Completion | 2026-06-03 |
| Phase | Phase 1 |
What the registry record for NCT02627443 still lists
NCT02627443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (72% lower).
The record links to 10 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT02627443 lists 14 locations in 10 states (Arizona, Florida, Michigan).
Frequently Asked Questions
What is clinical trial NCT02627443 about?
NCT02627443 is a clinical study titled "Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and berzosertib when given together with carboplatin in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metas...
What is the current status of trial NCT02627443?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2017-05-16. Estimated completion is 2026-06-03.
What conditions does trial NCT02627443 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Metastatic Ovarian Carcinoma.
What interventions are being tested in trial NCT02627443?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Gemcitabine Hydrochloride (DRUG), Berzosertib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02627443?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02627443 being conducted?
This trial has 14 study locations across Arizona, Colorado, Florida, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Ovarian Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02627443's enrollment target sits among peer trials
35 25th of 39 higher than 15 of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma 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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