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

Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04556539
Collaborator
(none)
104
Enrollment
1
Location
1
Arm
24.5
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SC10914 group

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

Outcome Measures

Primary Outcome Measures

  1. objective response rate (ORR) [up to 100 weeks (estimated)]

    assessed by the independent imaging assessment committee (recist1.1)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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<1.5×109/L PLT<100×109/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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Cancer Hospital Fujian China

Sponsors and Collaborators

  • Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04556539
Other Study ID Numbers:
  • QF-SC10914-201
First Posted:
Sep 21, 2020
Last Update Posted:
May 12, 2021
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of May 12, 2021