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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: fluzoparib monotherapy or combination therapy

Detailed Description

Ovarian cancer is one of the most serious malignant tumors that threaten women's health. The incidence rate is third place in the female reproductive system malignant tumors. The mortality rate ranks the first in gynecologic malignancies, and most of them are advanced at the time of diagnosis. The initial treatment of ovarian cancer is mainly surgery and adjuvant chemotherapy. Although most patients can obtain clinical remission after initial treatment, 70% of patients still relapse within 3 years. Therefore, finding effective drugs to prolong the chemotherapy-free interval and exploring comprehensive treatment schemes to prolong survival is the key to treatment.

In recent years, the advent of poly adenosine diphosphate ribose polymerase inhibitors has brought significant changes to the treatment of ovarian cancer. A series of high-level evidence-based medical evidence shows that the application of PARP inhibitors after complete and partial remission of initial treatment or platinum-sensitive recurrence treatment can significantly prolong the progression-free survival time of ovarian cancer patients, Maintenance therapy has become a new model for the treatment of ovarian cancer. At the same time, PARP inhibitors have been approved for posterior line treatment of ovarian cancer. At present, PARP inhibitors have been widely used in clinics and become an important cornerstone of the comprehensive treatment of ovarian cancer.

Fzocus-2 study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study of fluzoparib in the maintenance treatment of platinum-sensitive recurrent ovarian cancer. The preliminary results were published on the American Society of Gynecological Oncology (SGO) in 2021. A total of 252 patients were included in the study and were treated with fluzoparib (n = 167) or placebo (n = 85). The median follow-up time was 8.5 months. The population-wide data assessed by bIRC showed that the median PFS data were not mature. According to the Kaplan Meier curve, fluzoparib could significantly prolong the PFS (12.9 months: 5.5 months) and reduce the risk of disease progression or death by 75%.

Fzocus-3 is a phase IB study of fluzoparib approved for marketing, which included platinum-sensitive recurrent ovarian cancer patients with germline BRCA mutation who had previously received ≥ 3-line treatment. The objective remission rate of single-drug treatment is as high as 69.9%, and the median progression-free survival time is 12.0 months. It is well comparable with similar drugs and has good safety.

Fluzoparib was approved for the treatment of germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer in December 2020 and maintenance treatment of platinum-sensitive recurrent ovarian cancer in June 2021. A number of studies on fluzoparib in the field of ovarian cancer are also underway. It is urgent to obtain the real-world data of fluzoparib in the field of ovarian cancer in China. This study will collect information on the baseline characteristics, treatment, and management of ovarian cancer provided in the real world to illustrate the safety and effectiveness of fluzoparib in the treatment of ovarian cancer under the conditions of real clinical practice. It may also include various subgroups of patients with ovarian cancer, which are not involved in the existing phase III registered studies, In order to better understand and explore the use of PARP inhibitors in some patient subgroups and the treatment mode and effect of PARP inhibitors in the treatment of this disease.

• Study Type: Observational
• Enrollment (Anticipated): 490

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer had decided to use Fluzoparibb at the time of enrollment in this study

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fluzoparib treatment; patients with Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy	Drug: fluzoparib monotherapy or combination therapy; patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who underwent fluzoparib monotherapy or combination therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of other adverse event according to NCI CTCAE v5.0	the occasional or rare adverse events of fluzoparib in ovarian cancer under real-world conditions	30 days after the last dose of fluzoparib
overall survival (OS)	Overall survival, defined as time from first administration fluzoparib to documented death. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of overall survival (OS) in patients with Ovarian Cancer. Patients will be followed up once 3-6 months at least	6 years
Progression free survival (PFS)	Progression-free survival, defined as time from first administration fluzoparib to documented disease progression or death from any cause after baseline, whichever occurs first;. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of progression free survival (PFS) in patients with Ovarian Cancer. Patients will be followed up once 3-6 months at least.	6 years
Objective Response Rate (ORR)	Objective Response Rate, defined as percentage of patients with complete or partial response according to local assessments. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of objective response rate (ORR) in patients with Ovarian Cancer. Patients will be followed up once 12 weeks at least.	6 years
Disease Control Rate (DCR)	Disease Control Rate, defined as percentage of patients with complete or partial response or stable disease according to local assessments. To assess clinical effectiveness of fluzoparib monotherapy or combination therapy involved in this study by assessment of disease control rate (DCR) in patients with Ovarian Cancer. Patients will be followed up once 12 weeks at least.	6 years
Duration Of Therapy（DOT）	Duration Of Therapy, defined as the time from first administration fluzoparib to the permanent cessation of fluzoparib (including death).	6 years
Tumor marker expression level	Measurements of tumor biomarkers, such as : CA125, HRD, BRCA, etc.	6 years

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Wuhan Union Hospital, China; Zhejiang University; First Hospital of China Medical University; Yichang Central People's Hospital; Cancer Hospital of Guizhou Province; Affiliated Hospital of North Sichuan Medical College; Panzhihua Central Hospital; Wuhan Fourth Hospital; Cancer Hospital of Xinjiang Medical University; Qingyuan City People's Hospital; Liangshan First People's Hospital; Guang'an People's Hospital; Guizhou International General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: real world study
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 2022-TJ-FLU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No