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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Ovarian Cancer
• Intervention / Treatment: Drug: SC10914

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liu chunlei; Phone Number: 13911737489; Email: liuchunlei@sh-qingfeng.net
• Study Contact Backup: Name: Zhang zhe; Phone Number: 13115039707; Email: zhangzhe@sh-qingfeng.net

Study Locations

• China
  • Fujian, China
    • Recruiting
    • Fujian cancer hospital
    • Contact: Lin An

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SC10914 group	Drug: SC10914; 400mg TID, oral admination on fasting condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate (ORR)	assessed by the independent imaging assessment committee (recist1.1)	up to 100 weeks (estimated)

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: QF-SC10914-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No