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Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)

NCT00614393 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2018-08-08

Study results available
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Summary

This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic colorectal cancer (CRC) compared to cetuximab and irinotecan alone.

The primary study hypothesis is that administration of dalotuzumab in combination with cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype improves Overall Survival OR Progression-free Survival compared to participants treated with cetuximab and irinotecan alone.

Conditions

Interventions

BIOLOGICAL

dalotuzumab

IV infusion

DRUG

irinotecan hydrochloride

IV infusion

BIOLOGICAL

cetuximab

IV infusion

DRUG

placebo

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-24
Primary Completion
2010-06-01
Completion
2012-03-07

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Entities

Drugs
Diseases
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 NCT00614393 on ClinicalTrials.gov