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Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas

NCT03722108 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-10-16

No results posted yet for this study

Summary

Trial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.

Conditions

  • Adenocarcinoma of the Stomach
  • Adenocarcinoma of the Gastroesophageal Junction

Interventions

COMBINATION_PRODUCT

Regorafenib and Irinotecan

Irinotecan (180 mg/m² on D1 and D15 of a 4-week cycle) combined with regorafenib (160 mg daily on D2-8 and D16-22 of a 4-week cycle) administered until progression of disease or unacceptable toxicity

DRUG

Irinotecan

Irinotecan (180 mg/m² on D1 and D15 of a 4-week cycle) administered until progression of disease or unacceptable toxicity

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Emmanuelle SAMALIN-SCALZI, MD · Institut du Cancer Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2022-05-19
Completion
2022-05-19

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03722108 on ClinicalTrials.gov