Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
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|ClinicalTrials.gov Identifier: NCT04539327|
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
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.
|Condition or disease||Intervention/treatment|
|Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Rucaparib|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study|
|Actual Study Start Date :||July 29, 2020|
|Estimated Primary Completion Date :||July 29, 2021|
|Estimated Study Completion Date :||July 29, 2021|
- 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.
- Patient characteristics and medical history [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Month 10-12 ]
- Rucaparib dosing data [ Time Frame: Month 10-12 ]
- Data reproducibility [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539327
|Contact: Patricio Ledesma||+34 email@example.com|
|Principal Investigator:||Alfonso Yubero, Dr.||Hospital Clínico Universitario Lozano Blesa|