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

Ovarian Cancer Clinical Trial

— CONOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857397
• Other study ID #: LACOG 1220
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

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