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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Criteria

Inclusion Criteria:

1. Sign informed consent voluntarily;

2. ≥18 years old;

3. Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma);

4. gBRCA1/2 mutation positive;

5. Had recived at least 2 prior lines of chemotherapy;

6. Platinum sensitive patients;

7. The last line of therapy befor enrollment failed；

8. ECOG≤2；

8. Had at least one measurable lesion.

Exclusion Criteria:

1. Any previous treatment with PARP inhibitor;

2. Symptomatic brain metastases;

3. Large amount of fluid in the third gap；

4. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC<1.5×10^9/L PLT<100×10^9/L Hb<100g/L TBIL>1.5×ULN ALT, AST>2.5×ULN (without liver metastases) or ALT, AST>5×ULN (with liver metastases) Cr >1.5×ULN