BENITIONSClinical Trial Intelligence

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

2期 进行中(已停止招募) NCT02595892

适应症Ovarian Serous Tumor, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
分期2期
申办方National Cancer Institute (NCI)
状态进行中(已停止招募)
受试者人数70 人
干预(药物)Berzosertib, Gemcitabine, Gemcitabine Hydrochloride
开始日期2016年8月25日
完成日期2020年6月15日
结果公布日2022年10月25日

摘要

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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。