Phase I Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Participants With Colorectal Cancer (MK-0646-016)

• Status: Completed
• Trial end date: 2010-12-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antibodies, Monoclonal; Camptothecin; Cetuximab; Irinotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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