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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05857397
Other study ID # LACOG 1220
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 21, 2023
Est. completion date April 30, 2025

Study information

Verified date December 2023
Source Latin American Cooperative Oncology Group
Contact Diana Rostirolla
Phone +55 51 3384 5334
Email diana.rostirolla@lacogcancerresearch.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

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.

Locations

Country Name City State
Argentina Fundacion Medica de Rio Negro y Neuquen Neuquén
Argentina Sanatorio de la Mujer Rosario Santa Fé
Argentina COIP - Centro Oncologico Integral Pampeano Santa Rosa La Pampa
Brazil Hospital de Amor de Barretos Barretos São Paulo
Brazil Oncocentro de Minas Gerais (Oncoclínicas) Belo Horizonte Minas Gerais
Brazil IOP Pesquisa - Instituto de Oncologia do Paraná Curitiba Paraná
Brazil Hospital Amaral Carvalho de Jaú Jaú São Paulo
Brazil CINPAM - Centro Integrado de Pesquisa da Amazônia Manaus Amazonas
Brazil CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS Porto Alegre Rio Grande Do Sul
Brazil HMV - Hospital Moinhos de Vento Porto Alegre Rio Grande Do Sul
Brazil NOB - Núcleo de Oncologia da Bahia (Oncoclínicas) Salvador Bahia
Brazil BP - A Beneficência Portuguesa de São Paulo São Paulo
Brazil ICESP - Instituto do Câncer do Estado 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 Hospital Santa Rita de Cássia Vitória Espirito Santo

Sponsors (2)

Lead Sponsor Collaborator
Latin American Cooperative Oncology Group GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the safety profile To evaluate the safety profile, including dose modifications, of niraparib in patients with advanced ovarian cancer in response following first-line platinum-based chemotherapy treated in a real-world setting within the EAP. through study completion, an average of 36 months
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