Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539327
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2020-08-10
Brief Title:
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program RAP in Spain - A GEICO Study
Sponsor:
Grupo Español de Investigación en Cáncer de Ovario
Organization:
Grupo Español de Investigación en Cáncer de Ovario
Study Overview
Official Title:
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program RAP in Spain - A GEICO Study
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 characteristicsmedical history safety efficacy and dosing of on-label treatment with rucaparib in real-world patients real-world data
To describe patient characteristicsmedical 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
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 characteristicsmedical history safety efficacy and dosing of on-label treatment with rucaparib in real-world patients real-world data
To describe patient characteristicsmedical 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None