Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Cystadenocarcinoma, Serous

Fallopian Tube Neoplasms

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Angiogenesis Inhibitors

Fluzoparib

Poly(ADP-ribose) Polymerase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Fluzoparib capsule: oral administration, 3 capsules/dose (150 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 4 weeks is a treatment cycle.

Fluzoparib capsule: oral administration, 2 capsules/dose (100 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 4 weeks is a treatment cycle.

Apatinib: oral administration, 1 tablet/dose (375 mg/tablet), once a day, it is recommended to take orally within 0.5h after breakfast, continuous administration. Every 4 weeks is a treatment cycle.

Fluzoparib+Apatinib

Li Li

This is a randomized, multicenter, two-arm, noncomparative, phase II study of fluzoparib with or without apatinib for maintenance therapy in PARPi-pretreated platinum-sensitive recurrent ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib with or without apatinib.

Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi

A Randomized, Multicenter, Noncomparative Clinical Study of Fluzoparib With or Without Apatinib for Maintenance Therapy in PARPi-pretreated Platinum-sensitive Recurrent Ovarian Cancer

Time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first.

Time from the date of randomization to the date of death due to any cause.

ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

the proportion of patients with a best overall response of confirmed complete or partial response or stable disease based on RECIST v1.1.

TFST is defined as the time from the randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.

TSST is defined as the time from the randomization to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

Time to treatment failure by RECIST v. 1.1 or CA-125 or death is defined as the time from the randomization to the date of RECIST progression or death by any cause, whichever occurs first.

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Guangxi Medical University

Prof.

Participants will receive Fluzoparib-Apatinib combination until progression

Participants will receive Fluzoparib monotherapy until progression

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

Quanren Wang

Li bo

Jianqing Zhu

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.

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

Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment

Adverse Events and Serious Adverse Events

Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment

Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

Time from documentation of tumor response to disease progression assessed among patients who had an objective response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi	NCT06161272	Ovarian Cancer High Grade Sero... Primary Periton... Fallopian Tube ...	Fluzoparib Fluzoparib+Apat...	18 Years - 75 Years	Guangxi Medical University
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients	NCT04517357	Relapsed Ovaria...	Fluzoparib+Apat... Fluzoparib Fluzoparib+Apat...	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi	NCT06161272	Ovarian Cancer High Grade Sero... Primary Periton... Fallopian Tube ...	Fluzoparib Fluzoparib+Apat...	18 Years - 75 Years	Guangxi Medical University
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients	NCT04517357	Relapsed Ovaria...	Fluzoparib+Apat... Fluzoparib Fluzoparib+Apat...	18 Years -	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for fluzoparib+apatinib