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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC10914 group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC10914 | Drug | 400mg TID, oral admination on fasting condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | assessed by the independent imaging assessment committee (recist1.1) | up to 100 weeks (estimated) |
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Inclusion Criteria:
8. Had at least one measurable lesion.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu chunlei | Contact | 13911737489 | liuchunlei@sh-qingfeng.net | |
| Zhang zhe | Contact | 13115039707 | zhangzhe@sh-qingfeng.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fujian | China |
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