A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

NCT ID: NCT03075462

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2021-12-13

Brief Summary

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Conditions

Ovarian Cancer; Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluzoparib + Apatinib

Fluzoparib and apatinib will be separately administered to patients on the 1st and 4th day, respectively. Then from the 7th day they are administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Fluzoparib

Intervention Type: DRUG

Fluzoparib either at 40,60,80mg twice daily,capsule oral.

Apatinib

Intervention Type: DRUG

Apatinib at 250mg once daily, tablet oral

Interventions

Fluzoparib

Fluzoparib either at 40,60,80mg twice daily,capsule oral.

Intervention Type: DRUG

Apatinib

Apatinib at 250mg once daily, tablet oral

Intervention Type: DRUG

Other Intervention Names

SHR3162; HS10160

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer，primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC）, that is locally advanced or metastatic, are also eligible.
• Prior therapy：subjects with ovarian cancer，primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.
• At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline
• Subjects who have overall good overall general condition.
• Signed informed consent.

Exclusion Criteria

• Subjects who received any previous treatment with any PARP inhibitors.
• Subjects who received any previous treatment with any VEGFR inhibitors.
• Less than 4 weeks from the last clinical trial.
• Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
• Unstable or uncontrolled hypertension.
• Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
• Subjects with brain metastases.
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
• Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.
• Ongoing infection (determined by investigator).
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• Pregnant or breast-feeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hosptial

Beijing, Beijing Municipality, China

Countries

China

References

Liu Y, Wang W, Yin R, Zhang Y, Zhang Y, Zhang K, Pan H, Wang K, Lou G, Li G, Zhang R, Li K, Rao J, Zhang B, Wang Y, Wang Q, Gao Y, Li H. A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis. BMC Med. 2023 Sep 29;21(1):376. doi: 10.1186/s12916-023-03046-8.

Reference Type: DERIVED

PMID: 37775744 (View on PubMed)

Other Identifiers

FZPL-I-104-OC/BC

Identifier Type: -

Identifier Source: org_study_id