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

NCT02386397 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Digestive Cancer

Interventions

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

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • DOMERGUE Jacques · Institut régional du Cancer - Val d'Aurelle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02386397 on ClinicalTrials.gov