Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01639326
Status:
UNKNOWN
Last Update Posted:
2015-05-07
First Post:
2012-07-10
Brief Title:
Study to Evaluate the Efficacy and Safety of FOLFIRI-AD in Patients With Metastatic Colorectal Cancer UGT1A Genotype 1
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Phase II Randomized Pharmacogenetic Study to Evaluate the Efficacy and Safety of FOLFIRI Schedule With High Doses of Irinotecan FOLFIRI-AD in Patients With Metastatic Colorectal Cancer According to UGT1A Genotype 1
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
RECRUITING
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:
FOLFIRI-AD
Brief Summary:
This study aims to use the corresponding pharmacogenetic analysis to increase the dose of irinotecan in the schemes commonly used standard chemotherapy in advanced colorectal cancer treatment first The project aims to improve the therapeutic index of chemotherapy This optimization is raised based on the administration of different doses of the drug depending on the genotype UGT1A1 gene The research team proposes this project to demonstrate how the administration of high doses of irinotecan in the FOLFIRI scheme in patients with genotype UGT1A1 favorable wild homozygous 1 1 and heterozygous 1 28 significantly improves the efficiency of the antineoplastic agent without significant increase in toxicity Secondarily will assess the possible prognostic factors related to tolerance and efficacy
The primary objective is to evaluate the efficacy of high doses of irinotecan in the FOLFIRI scheme in patients with metastatic colorectal cancer with a favorable genotype UGT1A1 wild homozygous 1 1 and heterozygous 1 28
The primary objective is to evaluate the efficacy of high doses of irinotecan in the FOLFIRI scheme in patients with metastatic colorectal cancer with a favorable genotype UGT1A1 wild homozygous 1 1 and heterozygous 1 28
Detailed Description:
None
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