Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (RENI-1)

Ling-Ying Wu

Status: Not yet enrolling

Conditions: Epithelial Ovarian Cancer

Treatments: Drug: Niraparib

Study type: Observational

Funder types: Other

Identifiers

NCT04986371

21/251-2922

Details and patient eligibility

About

This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.

Full description

In this study, 300 patients will be enrolled. Eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. Patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. Patients will be treated with Niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. The primary endpoint is treatment pattern of Niraparib as first-line maintenance treatment for ovarian cancer patients. The second endpoints include AE, PFS and quality of life.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 years or older
• Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
• Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
• Understand the protocol, and Written informed consent before any study-related procedure

Exclusion criteria

• Participating in other clinical trials at the same time
• Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
• Having other malignant tumors (other than breast cancer with BRCA mutation)
• Pregnancy or breast feeding, or planning a pregnancy during the study
• Unable to visit on time
• Patients who are allergic to the study drug or drug components