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

February 11, 2025 updated by: Latin American Cooperative Oncology Group
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Neuquén, Argentina
        • Fundacion Medica de Rio Negro y Neuquen
    • La Pampa
      • Santa Rosa, La Pampa, Argentina
        • COIP - Centro Oncologico Integral Pampeano
    • Santa Fé
      • Rosario, Santa Fé, Argentina
        • Sanatorio de la Mujer
  • Brazil
      • São Paulo, Brazil, 01.246-000
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
      • São Paulo, Brazil, 01.323-030
        • BP - A Beneficencia Portuguesa de São Paulo
      • São Paulo, Brazil, 04.502-001
        • Instituto D'Or de Pesquisa e Ensino SP
      • São Paulo, Brazil
        • Pérola Byington Centro de Pesquisa
    • Amazonas
      • Manaus, Amazonas, Brazil, 69.020-030
        • CINPAM - Centro Integrado de Pesquisa da Amazônia
    • Bahia
      • Salvador, Bahia, Brazil, 40.170-110
        • NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)
    • Espirito Santo
      • Vitória, Espirito Santo, Brazil, 29.043-260
        • Hospital Santa Rita de Cassia
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30.360-680
        • Oncocentro de Minas Gerais (Oncoclínicas)
    • Paraná
      • Curitiba, Paraná, Brazil, 80.040-170
        • IOP Pesquisa - Instituto de Oncologia do Paraná
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-000
        • HMV - Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.610-000
        • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
    • São Paulo
      • Barretos, São Paulo, Brazil, 14.784-400
        • Hospital de Amor de Barretos
      • Jaú, São Paulo, Brazil, 17.210-120
        • Hospital Amaral Carvalho de Jau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult female patients with diagnosis of advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy, treated within the niraparib EAP.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety profile
Time Frame: through study completion, an average of 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Angélica Nogueira Rodrigues, Latin American Cooperative Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 1220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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