Status:
COMPLETED
Phase I Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Participants With Colorectal Cancer (MK-0646-016)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 parti...
Eligibility Criteria
Inclusion
- Is 20 years of Age or older
- Has a histologically or cytologically confirmed colorectal cancer
- Has 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 radiological evidence of progression as verified by previous radiologic scans
- Must have adequate organ function
Exclusion
- Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to initial dosing on this study or whose toxicities from agents administrated 4 weeks earlier have not resolved to at least grade 1 or baseline
- Has experienced intolerable toxicity to Irinotecan therapy
- Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors (e.g. Cetuximab)
- Is concurrently using growth hormone (GH), Or GH inhibitors
Key Trial Info
Start Date :
June 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00925015
Start Date
June 17 2009
End Date
December 6 2010
Last Update
August 15 2018
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