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Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer

NCT01919879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-05-08

No results posted yet for this study

Summary

This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.

Conditions

Interventions

DRUG

Cetuximab + Afatinib

Afatinib taken orally, cetuximab administered intravenously

DRUG

Cetuximab

Cetuximab administered intravenously

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Helene SENELLART, Dr · Centre René Gauducheau- Nantes Saint herbelain

  • Evelyne BOUCHER, Dr · Centre Eugène Marquis-Rennes

  • Eric FRANCOIS, Dr · Centre Antoine Lacassagne, Nice

  • Emmanuelle SAMALIN SCALZI, Dr · Centre Val d'Aurel-Paul Lamarque-Montpellier

  • Meher BEN ABDELGHANI, Dr · Centre Paul Strauss-Strasbourg

  • Antoine ADENIS, Pr · Centre Oscar Lambret_Lille

  • Christelle DE LA FOUCHARDIERE, Dr · Centre Léon Bérard, Lyon

  • François GHIRENGHELLI, Dr · Centre Georges Leclerc-Dijon

  • Olivier DUBROEUCQ, Dr · Centre Jean Godinot-Reims

  • Emmanuelle MITRY, Dr · Hopital Rene Huguenin_Intitut Curie_Paris

  • Christophe BORG, Pr · Hôpital Jean Minjoz-Besaçon

  • Yves BOUCARN, Dr · Institut Bergonié Bordeaux

  • Christophe BORG, Pr · Centre Hospitalier de Belfort-Montbelliard

  • Marion CHAUVENET, Dr · Centre Hospitalier Lyon Sud-Pierre Benite

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-11-30
Completion
2017-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01919879 on ClinicalTrials.gov