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

NCT04539327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2026-03-18

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Clovis Oncology, Inc.

    collaborator INDUSTRY

  • Grupo Español de Investigación en Cáncer de Ovario

    lead OTHER

Principal Investigators

  • Alfonso Yubero, Dr. · Hospital Clínico Universitario Lozano Blesa

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539327 on ClinicalTrials.gov