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A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

NCT01032291 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-05-21

Study results available
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Summary

The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.

Conditions

Interventions

DRUG

cetuximab

Intravenous infusions of cetuximab (400 mg/m\^2 Cycle 1 Day 1, thereafter 250 mg/m\^2), administered on days 1, 8, 15 and 22 of each 28 day cycle.

DRUG

lenalidomide

Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle

Sponsors & Collaborators

  • Celgene Corporation

    lead INDUSTRY

Principal Investigators

  • Eric Van Cutsem, M.D., Ph,D · Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium

  • Josep Tabernero, M.D. · Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Australia
  • Belgium
  • Germany
  • Italy
  • Spain
  • Sweden

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 NCT01032291 on ClinicalTrials.gov