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Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

NCT01715441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2026-02-05

No results posted yet for this study

Summary

The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.

Conditions

  • Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

Interventions

DRUG

Sorafenib and irinotecan combination

DRUG

Sorafenib monotherapy

DRUG

Irinotecan monotherapy

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Emmanuelle SAMALIN, MD · CRLC Val d'Aurelle-Paul Lamarque

  • Marc YCHOU, MD, · CRLC Val d'Aurelle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-03-31
Completion
2015-09-30

Countries

  • France

Study Locations

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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 NCT01715441 on ClinicalTrials.gov