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

NCT ID: NCT04556539

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-12-31

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.

Conditions

Advanced Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SC10914 group

Group Type: EXPERIMENTAL

SC10914

Intervention Type: DRUG

400mg TID, oral admination on fasting condition

Interventions

SC10914

400mg TID, oral admination on fasting condition

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Cancer Hospital

Fujian, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu chunlei

Role: CONTACT

liuchunlei@sh-qingfeng.net

13911737489

Zhang zhe

Role: CONTACT

zhangzhe@sh-qingfeng.net

13115039707

Facility Contacts

Lin An

Role: primary

Other Identifiers

QF-SC10914-201

Identifier Type: -

Identifier Source: org_study_id