CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Dalotuzumab 10 mg/kg +3 morebiological
Likely dose
Dalotuzumab 10 mg/kgfrom 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/NCT00925015
NCT00925015Phase 1Completed

A Phase I Study of MK-0646 in Combination With Cetuximab and Irinotecan in Patients With Advanced or Metastatic Colorectal Cancer

Merck Sharp & Dohme LLC·interventional·Posted Jun 19, 2009·Updated Aug 15, 2018

In Brief

A Phase 1 clinical trial evaluating Dalotuzumab 10 mg/kg, Cetuximab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 20 participants.

Detailed Summary

The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2009
Enrollment StartJun 17, 2009
Primary CompletionJul 28, 2010
Study CompletionDec 6, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.0 years ago

Interventions

Dalotuzumab 10 mg/kgbiological

Dalotuzumab at 10 mg/kg was intravenously administered once weekly

Cetuximabbiological

Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m\^2, followed by subsequent once weekly intravenous infusions of 250 mg/m\^2

Irinotecandrug

Irinotecan was administered with an intravenous infusion of 150 mg/m\^2, once every other week for 42 days

Dalotuzumab 15/7.5 mg/kgbiological

Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg