A Non-interventional Registry Study of Fluzoparib in the Treatment of Ovarian Cancer

NCT05206890 · tracked via the Priya Life Science China tracker

Sponsor

Tongji Hospital

Phase

Observational

Started

2022-01-14

Last updated

2022-01-26

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

fluzoparib monotherapy or combination therapyAll Fluzoparib trials (11) →All Combination Therapy trials (3) →

fluzoparib monotherapy or combination therapy: patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy

Study summary

Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis.

This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Sign informed consent and voluntarily join the study; 2. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer diagnosed by histology or cytology; 3. ≥ 18 years old; 4. The investigator determined that the patient could receive fluzoparib monotherapy or combination therapy; 5. For patients with fertility, effective contraceptive methods should be used during the study period and within 90 days after the last administration of fluzoparib Exclusion Criteria: 1. There is evidence that the patient is a pregnant or lactating woman; 2. Participating in any research with intervention measures other than routine clinical practice; 3. The researcher judges other situations that are not suitable for inclusion in the study;

Primary outcome measure(s)

incidence of ≥ grade 3 Hematology related adverse event according to NCI CTCAE v5.0 — 30 days after the last dose of fluzoparib
the safety of fluzoparib in ovarian cancer under real-world conditions, especially Incidence of Hematology related adverse reactions ≥ grade 3

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting

More Tongji Hospital trials in China

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer Recruiting

Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas Enrolling by invitation

Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Hepatocellular Carcinoma Recurrence Surveillance Recruiting

the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases Active, not recruiting

Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery Starting soon

Other trials for the same condition

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer Recruiting

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Active, not recruiting

Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer Active, not recruiting

A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer Recruiting

D9319C00001- 1L OC Mono Global RCT Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05206890 on ClinicalTrials.gov ↗ ← All trials in China