Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Carcinoma

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

Pharmaceutical Solutions

Bevacizumab

Angiogenesis Inhibitors

Fluzoparib

Poly(ADP-ribose) Polymerase Inhibitors

Antineoplastic Agents, Immunological

Growth 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 3 weeks is a treatment cycle.

Bevacizumab injection: intravenous, 15 mg/kg, every 3 weeks for a treatment cycle until disease progression or intolerable toxicity, up to a total of 15 months.

Fluzoparib Capsules

Chunyan Lan

Chunyan Lan, MD&PhD

This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.

First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

An Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Bevacizumab for Maintenance Therapy After First-line Platinum-containing Chemotherapy in BRCA Wild-type Advanced Ovarian Cancer

Open collection of homologous recombination deficiency status (HRD) status was performed to assess the impact of HRD status on the efficacy of fluazoparib in combination with bevacizumab.

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

Time from the date of first study treatment administration 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.

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

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

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

Determination of changes in PROs with EQ-5D-5L

Sun Yat-sen University

Prof.

Spots Global Cancer Trial Database for First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial