Status:
COMPLETED
Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the insulin-like growth factor type 1 receptor-1 (IGF-1R). Dalotuzumab may act through inhibition of insulin-like growth factor-1 (IGF...
Eligibility Criteria
Inclusion
- Participant must have confirmed wtKRAS CRC.
- Participant must have previously failed both irinotecan and oxaliplatin containing regimens, and should have progressed on or within 3 months of completing their last line of therapy with objective evidence of progression as verified by previous radiologic scans.
Exclusion
- Participant has had cancer treatment within 2 weeks before the first dose of study drug(s) or if the side effects from the drugs have not gone down to a certain level 2 weeks before the first dose of study drugs.
- Participant has had a bad side effect to irinotecan therapy.
- Participant has human immunodeficiency virus (HIV).
- Participant has Hepatitis B or C.
- Participant is pregnant or breast feeding or planning to have a child while on this study.
Key Trial Info
Start Date :
December 24 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2012
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT00614393
Start Date
December 24 2007
End Date
March 7 2012
Last Update
August 8 2018
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