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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04556539

Enrollment

104

Registered

2020-09-21

Start date

2020-12-15

Completion date

2022-12-31

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Ovarian Cancer

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.

Interventions

DRUGSC10914

400mg TID, oral admination on fasting condition

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 99 Years

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactLiu chunlei

liuchunlei@sh-qingfeng.net13911737489

Backup ContactZhang zhe

zhangzhe@sh-qingfeng.net13115039707

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026