Spots Global Cancer Trial Database for Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer
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Trial Identification
Brief Title: Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer
Official Title: SC10914 Monotherapy for gBRCA1/2 Mutation Advanced Ovarian Cancer Patients With at Least 2 Prior Lines of Chemotherapy: a Single Arm, Open Label, Multicenter Clinical Trial
Study ID: NCT04556539
Conditions
Interventions
Study Description
Brief Summary: A phase II, multicenter, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of SC10914 in subjects with gBRCA1/2 mutated advanced ovarian cancer in china.
Detailed Description: A total of 104 subjects with gBRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety and PK profile of SC10914. The subjects oral administration SC10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (PD) or the toxicity was intolerable. PK blood samples are planned to be collected for each enrolled subject on C1D28 visit.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Fujian Cancer Hospital, Fujian, , China
Contact Details
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