Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
Study Details
Study Description
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:
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To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data).
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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).
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To show that data obtained in clinical trials could be reproduced in non-screened patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Outcome Measures
Primary Outcome Measures
- 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.
- Rucaparib efficacy data [Month 10-12]
- Rucaparib dosing data [Month 10-12]
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
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Adult women (18 years or more at the time of diagnosis).
Exclusion Criteria:
- Patients without medical record available (lost, empty or unretrievable clinical information).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Torrecárdenas | Almería | Andalucía | Spain | 04009 |
| 2 | Hospital Universitario Virgen de la Victoria | Málaga | Andalucía | Spain | 29010 |
| 3 | Hospital Universitario Virgen del Rocío | Sevilla | Andalucía | Spain | 41013 |
| 4 | Hospital Universitario Nuestra Señora de Valme | Sevilla | Andalucía | Spain | 41014 |
| 5 | Hospital General San Jorge | Huesca | Aragón | Spain | 22004 |
| 6 | Hospital Clínico Universitario Lozano Blesa | Zaragoza | Aragón | Spain | 50009 |
| 7 | Hospital Universitario Miguel Servet | Zaragoza | Aragón | Spain | 50009 |
| 8 | Hospital del Mar | Barcelona | Catalunya | Spain | 08003 |
| 9 | Hospital Clínic i Provincial | Barcelona | Catalunya | Spain | 08036 |
| 10 | Instituto Valenciano De Oncologia | Valencia | Comunitat Valenciana | Spain | 46009 |
| 11 | Hospital Universitari i Politecnic La Fe | Valencia | Comunitat Valenciana | Spain | 46026 |
| 12 | Hospital Público Lluis Alcanyis | Xàtiva | Comunitat Valenciana | Spain | 46800 |
| 13 | Complejo Hospitalario Universitario de Pontevedra | Pontevedra | Galicia | Spain | 36071 |
| 14 | Hospital Universitario Son Espases | Palma De Mallorca | Islas Baleares | Spain | 07120 |
| 15 | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | Spain | 28942 |
| 16 | Hospital Universitario Infanta Sofía | San Sebastián de los Reyes | Madrid | Spain | 28702 |
| 17 | Hospital Universitario de Araba Txagorritxu | Gasteiz / Vitoria | País Basco | Spain | 01009 |
| 18 | Clínica Universidad de Navarra | Madrid | Spain | 28027 | |
| 19 | MD Anderson Cancer Center | Madrid | Spain | 28033 | |
| 20 | Hospital Clínico San Carlos | Madrid | Spain | 28040 | |
| 21 | Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | 28040 | |
| 22 | Hospital Universitario 12 Octubre | Madrid | Spain | 28041 | |
| 23 | Centro Integral Oncológico Clara Campal | Madrid | Spain | 28050 |
Sponsors and Collaborators
- Grupo Español de Investigación en Cáncer de Ovario
- Clovis Oncology, Inc.
Investigators
- Principal Investigator: Alfonso Yubero, Dr., Hospital Clínico Universitario Lozano Blesa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GEICO 87-R