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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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 Beneficência 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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