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ACTIVE NOT RECRUITING Phase 2

Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

NCT02595892 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 70 participants
Start Date 2016-08-25
Est. Completion 2026-08-05
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02595892

The ClinicalTrials.gov registry entry for NCT02595892 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02595892 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Massachusetts, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02595892?

The interventions under investigation include: Gemcitabine (DRUG), Gemcitabine Hydrochloride (DRUG), Berzosertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02595892?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial