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

Fallopian Tube Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539327
• Other study ID #: GEICO 87-R
• Status: Completed
• Start date: July 29, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2022
• Source: Grupo Español de Investigación en Cáncer de Ovario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Primary Peritoneal Cancer

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Torrecárdenas	Almería	Andalucía
Spain	Hospital Clínic i Provincial	Barcelona	Catalunya
Spain	Hospital del Mar	Barcelona	Catalunya
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Araba Txagorritxu	Gasteiz / Vitoria	País Basco
Spain	Hospital General San Jorge	Huesca	Aragón
Spain	Centro Integral Oncológico Clara Campal	Madrid
Spain	Clínica Universidad de Navarra	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 Octubre	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga	Andalucía
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Complejo Hospitalario Universitario de Pontevedra	Pontevedra	Galicia
Spain	Hospital Universitario Infanta Sofía	San Sebastián de los Reyes	Madrid
Spain	Hospital Universitario Nuestra Señora de Valme	Sevilla	Andalucía
Spain	Hospital Universitario Virgen del Rocío	Sevilla	Andalucía
Spain	Hospital Universitari i Politecnic La Fe	Valencia	Comunitat Valenciana
Spain	Instituto Valenciano De Oncologia	Valencia	Comunitat Valenciana
Spain	Hospital Público Lluis Alcanyis	Xàtiva	Comunitat Valenciana
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza	Aragón
Spain	Hospital Universitario Miguel Servet	Zaragoza	Aragón

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Español de Investigación en Cáncer de Ovario	Clovis Oncology, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics and medical history	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).	Month 10-12
Primary	Rucaparib safety data: Adverse Events	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.	Month 10-12
Primary	Rucaparib efficacy data		Month 10-12
Primary	Rucaparib dosing data		Month 10-12
Primary	Data reproducibility	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.	Month 10-12