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

NCT ID: NCT05857397

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2025-05-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Patients treated within the EAPs with niraparib for ovarian cancer

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

Observational study

Intervention Type: OTHER

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

Interventions

Observational study

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with advanced OC in response following first line platinum-based chemotherapy who were treated with niraparib within the EAP in Argentina and Brazil;
• Patients who have received at least one dose of niraparib in the EAP.

Exclusion Criteria

• Patients without medical record available (lost, empty or irretrievable clinical information).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angélica Nogueira Rodrigues

Role: PRINCIPAL_INVESTIGATOR

Latin American Cooperative Oncology Group

Locations

COIP - Centro Oncologico Integral Pampeano

Santa Rosa, La Pampa Province, Argentina

Sanatorio de la Mujer

Rosario, Santa Fe Province, Argentina

Fundacion Medica de Rio Negro y Neuquen

Neuquén, , Argentina

CINPAM - Centro Integrado de Pesquisa da Amazônia

Manaus, Amazonas, Brazil

Hospital Santa Rita de Cássia

Vitória, Espírito Santo, Brazil

NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)

Salvador, Estado de Bahia, Brazil

Oncocentro de Minas Gerais (Oncoclínicas)

Belo Horizonte, Minas Gerais, Brazil

IOP Pesquisa - Instituto de Oncologia do Paraná

Curitiba, Paraná, Brazil

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

Hospital Amaral Carvalho de Jaú

Jaú, São Paulo, Brazil

ICESP - Instituto do Câncer do Estado de São Paulo

São Paulo, , Brazil

BP - A Beneficência Portuguesa de São Paulo

São Paulo, , Brazil

Instituto D'Or de Pesquisa e Ensino SP

São Paulo, , Brazil

Pérola Byington Centro de Pesquisa

São Paulo, , Brazil

Countries

Argentina; Brazil

Other Identifiers

LACOG 1220

Identifier Type: -

Identifier Source: org_study_id