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NCT02595892 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 17
- Study locations
NCT02595892: Active Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02595892 is a Phase 2 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 70 participants, below the 122-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (43% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595892, a Phase 2 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 2
- Development phase
- 70 participants
- Enrollment target
- 17
- Study locations
Study Summary
This randomized phase II trial studies how well ATR kinase inhibitor M6620 (M6620) and gemcitabine hydrochloride work compared to standard treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement (recurrent). ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking an enzyme needed for cell growth, and may also help gemcitabine hydrochloride work better. Gemcitabine hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by blocking cells from growing and repairing themselves, causing them to die. It is not yet known whether adding ATR kinase inhibitor M6620 to standard treatment with gemcitabine hydrochloride is more effective than gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
Primary Outcome
PFS was summarized using Kaplan-Meier analyses and compared between the two arms using the logrank test. Additionally, PFS was analyzed using a Cox Proportional Hazards Model, including the stratification factor, and will be used to estimate the hazard ratio of the gemcitabine hydrochloride (gemcitabine)/ataxia telangiectasia mutated and Rad3-related (ATR) kinase inhibitor M6620 (formerly VX-970) arm relative to the gemcitabine alone arm and the associated 90% confidence interval. Disease progre
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Gemcitabine Hydrochloride
- DRUG Berzosertib
Study Locations (17)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
California
- UC San Diego Moores Cancer Center - La Jolla
- UC San Diego Medical Center - Hillcrest - San Diego
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Florida
- Mayo Clinic in Florida - Jacksonville
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Minnesota
- Mayo Clinic in Rochester - Rochester
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-08-25 |
| Est. Completion | 2026-08-05 |
| Phase | Phase 2 |
What the registry record for NCT02595892 still lists
NCT02595892 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 122-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (43% lower).
The record links to 4 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Gemcitabine is the first listed.
NCT02595892 lists 17 locations in 11 states (Massachusetts, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT02595892 about?
NCT02595892 is a clinical study titled "Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". This randomized phase II trial studies how well ATR kinase inhibitor M6620 (M6620) and gemcitabine hydrochloride work compared to standard treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period ...
What is the current status of trial NCT02595892?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2016-08-25. Estimated completion is 2026-08-05.
What conditions does trial NCT02595892 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Ovarian Serous Tumor.
What interventions are being tested in trial NCT02595892?
The interventions under investigation include: Gemcitabine (DRUG), Gemcitabine Hydrochloride (DRUG), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT02595892?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02595892 being conducted?
This trial has 17 study locations across Arizona, California, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02595892's enrollment target sits among peer trials
70 14th of 39 higher than 25 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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