Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer

NCT07783022 | Recruiting FDA Drug

• 1 other identifier: 2502-Exp139
• Study Type: observational
• Target: 1,920
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Introduction This non-interventional real-world study enrolls patients with ovarian cancer who receive niraparib as first-line maintenance therapy under routine clinical care. All patients receive physician-prescribed standard treatment without any study intervention. The administration of niraparib and concomitant medications is performed in accordance with the approved product labeling and individual clinical conditions. This study collects and analyzes real-world data concerning medication use, clinical efficacy and safety outcomes. It aims to evaluate the real-world efficacy, safety and treatment patterns of niraparib first-line maintenance therapy and explore the correlation between HRD-related biomarkers and clinical response. The results will enrich evidence-based data and support individualized optimal treatment strategies for ovarian cancer patients.
2. 2.Study Objectives 2.1 Primary Objective To evaluate the real-world efficacy of niraparib as first-line maintenance therapy in patients with advanced epithelial ovarian cancer, based on progression-free survival (PFS), chemotherapy-free interval (CFI), time to first subsequent therapy (TFST), and overall survival (OS).

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Time from initiation of niraparib first-line maintenance therapy to disease progression (per investigator assessment) or death from any cause, whichever occurs first.

  Up to 36 months after niraparib initiation

Study Arms (1)

Patients receiving niraparib first-line maintenance therapy

Drug: Niraparib (Tablet)

Interventions

Niraparib (Tablet) DRUG

Niraparib administered as first-line maintenance therapy per routine clinical physician prescription and approved product labeling. The study does not initiate, allocate, or modify treatment for participants.

Patients receiving niraparib first-line maintenance therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients aged ≥ 18 years with histologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (high-grade serous or high-grade endometrioid adenocarcinoma). Subjects received first-line platinum-based chemotherapy with CR/PR and niraparib first-line maintenance therapy in routine clinical practice. This is a non-interventional real-world cohort study.

You may qualify if:

• Female patients aged ≥ 18 years.
• Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• Histological subtype of high-grade serous carcinoma or high-grade endometrioid adenocarcinoma.
• Received only prior first-line platinum-based chemotherapy and achieved complete response (CR) or partial response (PR) to chemotherapy.
• Patients who received niraparib maintenance therapy in clinical practice.

You may not qualify if:

• Patients with comorbidities that, in the investigator's judgment, would seriously endanger patient safety or interfere with medication administration.
• Patients receiving anti-tumor drugs for other concurrent malignant neoplasms.
• Pregnant or breastfeeding patients.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib; Tablets

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Administrative Director and Associate Chief Physician, Department of Gynecologic Oncology

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)