Spots Global Cancer Trial Database for A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer
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Trial Identification
Brief Title: A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer
Official Title: A Phase III Study to Evaluate the Efficacy and Safety of IMP4297 Following 1st Line Chemotherapy in the Monotherapy Maintenance Treatment of Subjects With Ovarian Cancer
Study ID: NCT04169997
Conditions
Study Description
Brief Summary: IMP4297 is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of IMP4297 for Maintenance Treatment
Detailed Description: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IMP4297 Following First-Line Platinum-based Chemotherapy in the Monotherapy Maintenance Treatment of Subjects with International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV Ovarian Cancer. Subjects with newly diagnosed III/IV high-grade serous ovarian carcinoma (HGSOC) or other histological types of ovarian cancer, fallopian tube cancer or primary peritoneal cancer carrying breast cancer susceptibility gene (BRCA) mutation who have had a complete/partial response (CR/PR) after first-line platinum-based therapy will be randomly assigned to IMP4297 or placebo at a 2:1 ratio.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sun Yat-sen University Cancer Center, Guanzhou, Guangdong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
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