At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
IMC-11F8 (necitumumab) +3 morebiological
Likely dose
IMC-11F8 (necitumumab) 800 milligramsfrom 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.
Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating IMC-11F8 (necitumumab), Oxaliplatin, and 2 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 44 participants across 5 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesBelgium, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedFeb 2009
Primary CompletionJan 2010
Study CompletionOct 2010
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.4 years ago
Interventions
IMC-11F8 (necitumumab)biological
IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1
Oxaliplatindrug
Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1
Folinic acid (FA)drug
FA 400 mg/m² IV infusion bolus injection
5-FUdrug
5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours