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

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Advanced Ovarian Cancer

Treatments: Drug: SC10914

Study type: Interventional

Funder types: Industry

Identifiers

NCT04556539

QF-SC10914-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No 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；

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<1.5×10^9/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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

SC10914 group

Experimental group

Treatment:

Drug: SC10914