Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study

Completed

• Conditions: Primary Peritoneal Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer

• Registration Number: NCT04539327
• Lead Sponsor: Grupo Español de Investigación en Cáncer de Ovario

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-29
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-07
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rucaparib efficacy data	Month 10-12
Rucaparib dosing data	Month 10-12
Patient characteristics and medical history	Month 10-12	Sex, age, mutational status (BRCA 1/2 \[germline/somatic\] and in other homologous recombination repair (HRR) genes), number of previous relapses, number of previous chemotherapy regimens, types of treatments received (chemotherapy, targeted therapies \[bevacizumab, PARP inhibitors (PARPi)\]), prior maintenance or with maintenance, treatment-free interval (platinum-based chemotherapy, non-platinum-based chemotherapy, targeted therapy).
Rucaparib safety data: Adverse Events	Month 10-12	All rucaparib-related hematological and non-hematological, serious and non-serious adverse events (grade, start date, end date, action taken with rucaparib, outcome). In addition, adverse event treatments will be registered in the study database.
Data reproducibility	Month 10-12	In order to show that data obtained in clinical trials could be reproduced in non-screened patients, the outcomes will be discussed in the context of the results from ARIEL3 trial and the integrated analysis of Study 10 and ARIEL2.

Trial Locations

Locations (23)

Hospital Torrecárdenas; 🇪🇸 Almería, Andalucía, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Comunitat Valenciana, Spain

Complejo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Galicia, Spain

Hospital del Mar; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Andalucía, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Andalucía, Spain

Hospital Universitario Nuestra Señora de Valme; 🇪🇸 Sevilla, Andalucía, Spain

Hospital General San Jorge; 🇪🇸 Huesca, Aragón, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Aragón, Spain

Instituto Valenciano De Oncologia; 🇪🇸 Valencia, Comunitat Valenciana, Spain

Hospital Clínic i Provincial; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Público Lluis Alcanyis; 🇪🇸 Xàtiva, Comunitat Valenciana, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario Infanta Sofía; 🇪🇸 San Sebastián de los Reyes, Madrid, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Islas Baleares, Spain

Hospital Universitario de Araba Txagorritxu; 🇪🇸 Gasteiz / Vitoria, País Basco, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario 12 Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Centro Integral Oncológico Clara Campal; 🇪🇸 Madrid, Spain

MD Anderson Cancer Center; 🇪🇸 Madrid, Spain

Clínica Universidad de Navarra; 🇪🇸 Madrid, Spain