Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02386397
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
2015-03-02
Brief Title:
Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
Activity of Regorafenib in Combination With Modified Gemcitabine - Oxaliplatin Chemotherapy mGEMOX in Patients With Advanced Biliary Tract Cancer BTC A Phase Ib-II Trial BREGO
Status:
COMPLETED
Status Verified Date:
2017-08
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:
BREGO
Brief Summary:
This study is to determine the Regorafenib Dose RD for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer
Detailed Description:
Regorafenib BAY 73-4506 was assessed in metastatic colorectal cancer in the phase III randomized CORRECT trial 760 metastatic colorectal cancer patients were recruited after the failure of all standard therapies
Given the promising efficacy and favorable tolerability profile of mGEMOX and the potential benefits of targeting the VEGF and RasRaf pathway we propose to assess the combination of Regorafenib with mGEMOX in advanced digestive cancer
This study is to determine the Regorafenib Dose RD for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer
The phase I study of Regorafenib in advanced colorectal cancer showed a pronounced interindividual variability of drug exposition Furthermore the CORRECT study shows a large pharmacological variability of plasma concentration for Regorafenib and its metabolites In this study we propose to explore the pharmacological variability and his potential heritability by the therapeutic drug monitoring of Regorafenib The objective is to understand and to control the pharmacological variability of Regorafenib and finally to predict the therapeutic response or the toxicity especially in a population of patients with biliary tract cancer
In addition we will complete this study by exploring the gene variants of drug metabolism The genes are POR P450 OxidoReductase NR1I2 Nuclear Receptor subfamily 1 group I member 2 and a part of the regulatory sequences of CYP3A4
Given the promising efficacy and favorable tolerability profile of mGEMOX and the potential benefits of targeting the VEGF and RasRaf pathway we propose to assess the combination of Regorafenib with mGEMOX in advanced digestive cancer
This study is to determine the Regorafenib Dose RD for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer
The phase I study of Regorafenib in advanced colorectal cancer showed a pronounced interindividual variability of drug exposition Furthermore the CORRECT study shows a large pharmacological variability of plasma concentration for Regorafenib and its metabolites In this study we propose to explore the pharmacological variability and his potential heritability by the therapeutic drug monitoring of Regorafenib The objective is to understand and to control the pharmacological variability of Regorafenib and finally to predict the therapeutic response or the toxicity especially in a population of patients with biliary tract cancer
In addition we will complete this study by exploring the gene variants of drug metabolism The genes are POR P450 OxidoReductase NR1I2 Nuclear Receptor subfamily 1 group I member 2 and a part of the regulatory sequences of CYP3A4
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