NCT02386397

Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 Ras/Raf 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.

Conditions

• Digestive Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib: X mg/d, PO, from day 1 to day 14; day 15 to day 20: off-treatment
DRUG	GEMOX	mGEMOX: infusion on days 1 and 8: Gemcitabine 900 mg/m² IV in 30 minutes Oxaliplatin 80 mg/m² IV in 120 minutes immediately after Gemcitabine

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-03-11
• Last updated: 2026-03-12

Locations

1 site across 1 country: France