NCT04539327

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Grupo Español de Investigación en Cáncer de Ovario · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

An observational study (GEICO 87-R) was performed in high-grade ovarian cancer patients treated within the rucaparib access program (RAP) in Spain. The aim was to better understand rucaparib's management in real-life setting, to optimize future use, considering Pt-sensitive and Pt-resistant BRCAmut treatment and maintenance patients. A retrospective study was performed at 22 GEICO hospitals in Spain that treated patients within RAP (600 mg BID) since September 2018. Adult women with high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer, with medical record available, were included. Patient characteristics, medical history, safety, efficacy, and dosing data were collected. The setting of this observational study was rucaparib's access program (RAP) in Spain, in the context of real-life use of the product.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Rucaparib	Participating local sites (GEICO-associated hospitals with expertise in gynecological cancer management) will enter clinical data of those patients who have previously participated in the rucaparib access program (RAP) in Spain and have given their consent.

Timeline

• Start date: 2020-07-29
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-09-07
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

23 sites across 1 country: Spain