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

Primary Purpose

Advanced Ovarian Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SC10914
Sponsored by
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Ovarian Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SC10914 group

Arm Description

Outcomes

Primary Outcome Measures

objective response rate (ORR)
assessed by the independent imaging assessment committee (recist1.1)

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
May 11, 2021
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04556539
Brief Title
Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SC10914 group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SC10914
Intervention Description
400mg TID, oral admination on fasting condition
Primary Outcome Measure Information:
Title
objective response rate (ORR)
Description
assessed by the independent imaging assessment committee (recist1.1)
Time Frame
up to 100 weeks (estimated)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sign informed consent voluntarily; ≥18 years old; Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma); gBRCA1/2 mutation positive; Had recived at least 2 prior lines of chemotherapy; Platinum sensitive patients; The last line of therapy befor enrollment failed； ECOG≤2； 8. Had at least one measurable lesion. Exclusion Criteria: Any previous treatment with PARP inhibitor; Symptomatic brain metastases; Large amount of fluid in the third gap； 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu chunlei
Phone
13911737489
Email
liuchunlei@sh-qingfeng.net
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang zhe
Phone
13115039707
Email
zhangzhe@sh-qingfeng.net
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin An

12. IPD Sharing Statement

Learn more about this trial

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

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