Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02310477
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2014-10-08
Brief Title:
Regorafenib in Metastatic Colorectal Cancer a Cohort Study in the Real-life Setting
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
REBECCA A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-01
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:
REBECCA
Brief Summary:
This is a largest cohort study aimed to estimate the overall survival of patients been treated with regorafenib for metastatic colorectal cancer mCRC within the frame of a french compassionate program
Detailed Description:
Regorafenib REG is a multi-kinase inhibitor with survival benefits in patients with pretreated mCRC as demonstrated in the phase III CORRECT study As a result REG has been made available for medical practice use in the US and in the Europe However prescribing conditions in the real-life setting are known to be less stringent than selection criteria in clinical trials The REgorafeniB in mEtastatic Colorectal cancer a French Compassionate progrAm REBECCA is an ambispective cohort study designed to elucidate safety and effectiveness outcomes associated with REG as used in clinical practice for mCRC who have been previously treated with or are not considered candidates for available therapies
Patients were identified from the database of the French ATU Temporary Authorization for Use approved by the French Health Authorities to provide early access to innovative not yet approved medicinal products such as REG
Baseline patient and tumor characteristics REG dosing and dose-intensity REG-related adverse events pre- and post REG treatments predictors of events and effectiveness data PFS OS were collected from patients who agreed and whom physicians accepted to collaborate on the REBECCA cohort
Patients were identified from the database of the French ATU Temporary Authorization for Use approved by the French Health Authorities to provide early access to innovative not yet approved medicinal products such as REG
Baseline patient and tumor characteristics REG dosing and dose-intensity REG-related adverse events pre- and post REG treatments predictors of events and effectiveness data PFS OS were collected from patients who agreed and whom physicians accepted to collaborate on the REBECCA cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None