Clinical trial NCT04539327: Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
Official title: Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: Rucaparib
Lead sponsor: Grupo Español de Investigación en Cáncer de Ovario
Sponsor class: OTHER
Collaborators: name: Clovis Oncology, Inc.
First posted: 2020-09-07
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (18 years or more) women diagnosed with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer

Brief summary: The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib).

A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant.

The specific objectives of the study are:

* To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data).
* To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data).
* To show that data obtained in clinical trials could be reproduced in non-screened patients.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccessible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).

Exclusion Criteria:

1. Patients without medical record available (lost, empty or unretrievable clinical information).

Primary outcomes:
measure: Patient characteristics and medical history
timeFrame: Month 10-12
measure: Rucaparib safety data: Adverse Events
timeFrame: Month 10-12
measure: Rucaparib efficacy data
timeFrame: Month 10-12
measure: Rucaparib dosing data
timeFrame: Month 10-12
measure: Data reproducibility
timeFrame: Month 10-12
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Torrecárdenas
state: Andalucía
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
state: Andalucía
city: Huesca
country: Spain
facility: Hospital General San Jorge
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
state: Catalunya
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia
state: Comunitat Valenciana
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunitat Valenciana
city: Xàtiva
country: Spain
facility: Hospital Público Lluis Alcanyis
state: Comunitat Valenciana
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario de Araba Txagorritxu
state: País Basco
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
Study officials:
affiliation: Hospital Clínico Universitario Lozano Blesa
name: Alfonso Yubero, Dr.
role: PRINCIPAL_INVESTIGATOR
References: