Trials / Unknown
UnknownNCT04556539
Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SC10914 | 400mg TID, oral admination on fasting condition |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2021-12-31
- Completion
- 2022-12-31
- First posted
- 2020-09-21
- Last updated
- 2021-05-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04556539. Inclusion in this directory is not an endorsement.