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

Sponsor

Latin American Cooperative Oncology Group (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05857397

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Other: Observational study

Study Design

Study Type:

Observational

Anticipated Enrollment :

96 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Evaluate the safety profile [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Latin American Cooperative Oncology Group
GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Latin American Cooperative Oncology Group

ClinicalTrials.gov Identifier:

NCT05857397

Other Study ID Numbers:

LACOG 1220

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of May 12, 2023