BENITIONSClinical Trial Intelligence

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

Phase 2 Active, not recruiting NCT02595892

ConditionOvarian Serous Tumor, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment70 participants
InterventionsBerzosertib, Gemcitabine, Gemcitabine Hydrochloride
Start dateAug 25, 2016
Completion dateJun 15, 2020
Results postedOct 25, 2022

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
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)22.9 Weeks
p-value0.044
Hazard Ratio (HR)0.57 (95% CI .33–.98)

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