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

Phase 2

• Conditions: Advanced Ovarian Cancer
• Interventions: Drug: SC10914

• Registration Number: NCT04556539
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-21
• Study Start: 2020-12-15
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 104

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；

9. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SC10914 group	SC10914	-

Primary Outcome Measures

Name	Time	Method
objective response rate (ORR)	up to 100 weeks (estimated)	assessed by the independent imaging assessment committee (recist1.1)

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fujian, China