CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 558 enrolled
Drug / intervention
dalotuzumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00614393
NCT00614393Phase 2Completed
CompareCT.gov

A Phase II/III Study of Dalotuzumab (MK-0646) Treatment in Combination With Cetuximab and Irinotecan for Patients With Metastatic Colorectal Cancer

Merck Sharp & Dohme LLC·interventional·Posted Feb 13, 2008·Updated Aug 8, 2018

In Brief

A Phase 2 clinical trial evaluating dalotuzumab, irinotecan hydrochloride, and 2 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 558 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2008
Enrollment StartDec 24, 2007
Primary CompletionJun 1, 2010
Study CompletionMar 7, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.4 years ago

Interventions

dalotuzumabbiological

IV infusion

irinotecan hydrochloridedrug

IV infusion

cetuximabbiological

IV infusion

placebodrug

IV infusion