A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

NCT ID: NCT04517357

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2024-11-01

Brief Summary

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

Conditions

Relapsed Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety Lead-in or Parallel， Fluzoparib+Apatinib

Participants will receive Fluzoparib-Apatinib combination until progression

Group Type: EXPERIMENTAL

Fluzoparib+Apatinib

Intervention Type: DRUG

Fluzoparib-Apatinib combination

Fluzoparib monotherapy

Participants will receive Fluzoparib monotherapy until progression

Group Type: ACTIVE_COMPARATOR

Fluzoparib

Intervention Type: DRUG

Fluzoparib monotherapy

Exploratory cohort: Fluzoparib+Apatinib

Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression

Group Type: OTHER

Fluzoparib+Apatinib

Intervention Type: DRUG

Fluzoparib-Apatinib combination

Interventions

Fluzoparib+Apatinib

Fluzoparib-Apatinib combination

Intervention Type: DRUG

Fluzoparib

Fluzoparib monotherapy

Intervention Type: DRUG

Fluzoparib+Apatinib

Fluzoparib-Apatinib combination

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.

2. Patients must have received at least 2 previous platinum-containing regimens.

3. At least one target lesion.

4. ECOG performance status 0-1.

5. Adequate bone marrow, kidney and liver function.

Exclusion Criteria

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;

2. Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;

3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;

4. Known to be human immunodeficiency virus positive;

5. Known active hepatitis C virus, or known active hepatitis B virus;

6. Untreated and/or uncontrolled brain metastases;

7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;

8. Pregnant or breast-feeding women.

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

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

FZPL-II-201

Identifier Type: -

Identifier Source: org_study_id