Clinical trial NCT05857397: A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
Official title: A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-05-12
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evaluate the safety profile
timeFrame: through study completion, an average of 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Rosa
country: Argentina
facility: COIP - Centro Oncologico Integral Pampeano
state: La Pampa
city: Rosario
country: Argentina
facility: Sanatorio de la Mujer
state: Santa Fé
city: Neuquén
country: Argentina
facility: Fundacion Medica de Rio Negro y Neuquen
city: Manaus
country: Brazil
facility: CINPAM - Centro Integrado de Pesquisa da Amazônia
state: Amazonas
city: Salvador
country: Brazil
facility: NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)
state: Bahia
city: Vitória
country: Brazil
facility: Hospital Santa Rita de Cássia
state: Espirito Santo
city: Belo Horizonte
country: Brazil
facility: Oncocentro de Minas Gerais (Oncoclínicas)
state: Minas Gerais
city: Curitiba
country: Brazil
facility: IOP Pesquisa - Instituto de Oncologia do Paraná
state: Paraná
city: Porto Alegre
country: Brazil
facility: HMV - Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Amor de Barretos
state: São Paulo
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho de Jaú
state: São Paulo
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo
city: São Paulo
country: Brazil
facility: BP - A Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino SP
city: São Paulo
country: Brazil
facility: Pérola Byington Centro de Pesquisa
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Angélica Nogueira Rodrigues
role: PRINCIPAL_INVESTIGATOR
References: