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

Advanced Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04556539
• Other study ID #: QF-SC10914-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2020
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Liu chunlei
• Phone: 13911737489
• Email: liuchunlei[@]sh-qingfeng.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• SC10914
400mg TID, oral admination on fasting condition

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate (ORR)	assessed by the independent imaging assessment committee (recist1.1)	up to 100 weeks (estimated)