CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Cetuximabdrug
Likely dose
Cetuximab 500 milligramfrom 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/NCT01450319
NCT01450319Phase 2Completed
CompareCT.gov

Phase II Clinical Study of Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favourable FcγR IIa (CD32) Genotype

Merck KGaA, Darmstadt, Germany·interventional·Posted Oct 12, 2011·Updated Nov 28, 2016

In Brief

A Phase 2 clinical trial evaluating Cetuximab for Colorectal Neoplasms. Completed, enrolled 73 participants across 9 sites.

Detailed Summary

This national, multicenter, open-label phase 2 study without any control arm aims to evaluate the activity of cetuximab monotherapy in the treatment of refractory colorectal cancer in subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no therapeutic alternative for treatment. Failure of the first and second line conventional therapeutic lines was documented.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Neoplasms
CountriesSpain
CollaboratorsMerck, S.L., Spain

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2011
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.7 years ago

Interventions

Cetuximabdrug

Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m\^2) every 2 weeks until disease progression, death, or consent withdrawal.