Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Phase 2
Active, not recruiting
NCT02595892
| Condition | Ovarian Serous Tumor, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 70 participants |
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| Interventions | Berzosertib, Gemcitabine, Gemcitabine Hydrochloride |
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| Start date | Aug 25, 2016 |
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| Completion date | Jun 15, 2020 |
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| Results posted | Oct 25, 2022 |
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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.
Progression Free Survival (PFS)
Number of days from the day the subject received the first dose of protocol therapy to the date of documented progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death (regardless of cause), assessed up to 3 years · Weeks
| Arm I (Gemcitabine Hydrochloride) | 14.7 Weeks |
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| Arm II (Gemcitabine, ATR Kinase Inhibitor M6620) | 22.9 Weeks |
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| p-value | 0.044 |
| Hazard Ratio (HR) | 0.57 (95% CI .33–.98) |
Open in BENITIONS
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