Brief Title
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
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.
Study Type
Observational
Primary Outcome
Patient characteristics and medical history
Condition
Epithelial Ovarian Cancer
Intervention
Rucaparib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
52
Start Date
July 29, 2020
Completion Date
July 31, 2021
Primary Completion Date
July 31, 2021
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).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alfonso Yubero, Dr., ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04539327
Organization ID
GEICO 87-R
Responsible Party
Sponsor
Study Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Collaborators
Clovis Oncology, Inc.
Study Sponsor
Alfonso Yubero, Dr., Principal Investigator, Hospital Clínico Universitario Lozano Blesa
Verification Date
September 2022