NCT05857397

A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Latin American Cooperative Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Data from niraparib treatment is not available in real-world setting in Latin America. The present study aims to collect data from patients treated with niraparib within the Latin America Expanded Access Program (EAP) in clinical practice in Brazil and Argentina and who meet the eligibility criteria for this study, without additional intervention.

Detailed description

This is a multicenter, retrospective and prospective (bi-directional) patient chart review, observational (non-interventional) study, in the patients treated within the Latin America EAP. The study is planned to be conducted at oncology services distributed in Argentina and Brazil. Its multicenter nature aims to improve the representativeness of the study population in the region. Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria in the sites previously involved in the EAP. The follow-up data collection will be performed using a combination of medical records and patients' interviews. For patients that had interrupted the treatment before study start, the study comprises a single study visit with retrospective data collection from medical charts, followed by follow-up overall survival status, progression-free survival and time to next treatment performed by medical chart review or by phone call at month 12, month 24 and month 36 from the first dose of niraparib. For those that were still in treatment, data collection will be performed during the regular visits to the services involved in the study, using a combination of medical records abstraction and patient's interviews.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
OTHER	Observational study	This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

Timeline

• Start date: 2023-07-21
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-05-12
• Last updated: 2025-02-12

Locations

16 sites across 2 countries: Argentina, Brazil