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Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer

Advanced Ovarian Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04556539
Study type Interventional
Source Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Contact Liu chunlei
Phone 13911737489
Email liuchunlei@sh-qingfeng.net
Status Recruiting
Phase Phase 2
Start date December 15, 2020
Completion date December 31, 2022
View Details
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