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A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients

NCT04517357•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

October 16, 2020

Primary Completion Date

November 30, 2023

Completion Date

November 1, 2024

Last Updated

February 24, 2025

Enrollment

100

ACTUAL participants

Conditions

Relapsed Ovarian Cancer

Interventions

Fluzoparib+Apatinib

DRUG

Fluzoparib

DRUG

Fluzoparib+Apatinib

DRUG

OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

NCT04713514

Platinum-sensitive Ovarian CancerRelapsed Ovarian Cancer

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NOT_YET_RECRUITINGPHASE2

Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

NCT06446206

Platinum-sensitive Relapsed Ovarian Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status