NCT05857397

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
2 countries

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

March 6, 2023

Last Update Submit

February 11, 2025

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Observational studyOTHER

This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

Patients treated within the EAPs with niraparib for ovarian cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without medical record available (lost, empty or irretrievable clinical information).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

COIP - Centro Oncologico Integral Pampeano

Santa Rosa, La Pampa Province, Argentina

Location

Sanatorio de la Mujer

Rosario, Santa Fe Province, Argentina

Location

Fundacion Medica de Rio Negro y Neuquen

Neuquén, Argentina

Location

CINPAM - Centro Integrado de Pesquisa da Amazônia

Manaus, Amazonas, 69.020-030, Brazil

Location

Hospital Santa Rita de Cássia

Vitória, Espírito Santo, 29.043-260, Brazil

Location

NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)

Salvador, Estado de Bahia, 40.170-110, Brazil

Location

Oncocentro de Minas Gerais (Oncoclínicas)

Belo Horizonte, Minas Gerais, 30.360-680, Brazil

Location

IOP Pesquisa - Instituto de Oncologia do Paraná

Curitiba, Paraná, 80.040-170, Brazil

Location

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90.035-000, Brazil

Location

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90.610-000, Brazil

Location

Hospital de Amor de Barretos

Barretos, São Paulo, 14.784-400, Brazil

Location

Hospital Amaral Carvalho de Jaú

Jaú, São Paulo, 17.210-120, Brazil

Location

ICESP - Instituto do Câncer do Estado de São Paulo

São Paulo, 01.246-000, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, 01.323-030, Brazil

Location

Instituto D'Or de Pesquisa e Ensino SP

São Paulo, 04.502-001, Brazil

Location

Pérola Byington Centro de Pesquisa

São Paulo, Brazil

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Angélica Nogueira Rodrigues

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

May 12, 2023

Study Start

July 21, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(13)AR(3)