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

NCT02386397 | Completed Phase 1 DMC

• 1 other identifier: ICM2013/09
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Cancer

Outcome Measures

Primary Outcomes (1)

• Limiting toxicity

  To assess Limiting Toxicities during and within 6 weeks (2 cycles) after the beginning of the treatment.

  up to 5 years

Study Arms (2)

Treatment

EXPERIMENTAL

Regorafenib: X mg/d, PO, from day 1 to day 14; day 15 to day 20: off-treatment 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

Drug: Regorafenib; Drug: GEMOX

Standard treatment

OTHER

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

Drug: GEMOX

Interventions

GEMOX DRUG

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

Also known as: Gemcitabine, Oxaliplatin

Standard treatment; Treatment

Regorafenib DRUG

Regorafenib: X mg/d, PO, from day 1 to day 14; day 15 to day 20: off-treatment

Also known as: Gemcitabin, Oxaliplatin

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adenocarcinoma of the biliary tract
• Metastatic disease with no curative surgery option or metastatic recurrence after resection.
• Only for phase II: At least one measurable lesion in a non-irradiated area according to Response Evaluation Criteria in Solid Tumors
• No biliary obstruction.
• Age between 18 and 75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy higher than 3 months.
• No prior chemotherapy for advanced disease. Previous adjuvant chemotherapy including Gemcitabine and/or platinum based is allowed if completed at least 6 months previously and relapsing after completion of the last dose.
• Aminotransferases (AST, ALT) ≤ 2.5 ULN (≤ 5 ULN in case of diffuse hepatic involvement), INR \< 1.5 (following vitamin K1 injection in patients with current or recent history of jaundice or bile duct obstruction), serum creatinine clearance calculated \> 50 mL/min/1.73m² according to the Modification of Diet in Renal Disease (MDRD) formula, neutrophils ≥ 1.5.109/L, platelets ≥ 100.109/L, hemoglobin ≥ 9 g/dL (red blood cell transfusion is allowed if needed).
• Signed informed consent obtained before any study specific procedures.
• Patients must be affiliated to a Social Security System.

You may not qualify if:

• Known central nervous system metastases.
• Known history of human immunodeficiency virus (HIV) infection
• Contraindication or history of allergic reaction to one of the treatment components.
• Previous irradiation (external radiotherapy or brachytherapy) within 30 days prior to study treatment.
• Major surgery within 30 days prior to study treatment.
• Participation in another clinical trial within 30 days prior to study treatment.
• Concomitant systemic immunotherapy, chemotherapy, antitumor hormone therapy, targeted therapy or any experimental therapy.
• Active uncontrolled infection, peripheral neuropathy grade ≥ 2, acute or subacute bowel obstruction, history of inflammatory bowel disease, interstitial pneumonitis, respiratory failure, renal failure, dysphagia or any malabsorption condition.
• Symptomatic coronary heart disease or myocardial infarction in the past 6 months, congestive heart failure (NYHA class II), prior cerebrovascular accident.
• Uncontrolled hypertension (systolic blood pressure (BP) \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management).
• Proteinuria of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ≥ grade 2 (i.e. urinary protein ≥ 1.0 g/24 hrs).
• Patients with current or anticipated need for strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.
• Other malignancies either currently active or in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
• Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

• Blanc JF, Bouattour M, Gauthier L, Deshayes E, Guillemard S, Touchefeu Y, Portales F, Borg C, Harguem L, Guimbaud R, Mineur L, Ychou M, Mazard T, Assenat E. Regorafenib plus modified gemcitabine-oxaliplatin in patients with advanced biliary tract cancer. The randomized phase Ib/II BREGO study. Oncologist. 2025 Jun 4;30(6):oyaf080. doi: 10.1093/oncolo/oyaf080.

  PMID: 40542585 RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

regorafenib; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• DOMERGUE Jacques

  Institut régional du Cancer - Val d'Aurelle

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 11, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)