Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.

The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Participant has metastatic or locally advanced solid tumor or multiple myeloma

• Tumor specimen has IGF-1R expression

• Participant agrees to use birth control throughout study

Exclusion Criteria:

• Participant must not be recovering from antineoplastic therapy in the last 4 weeks

• Participant has participated in a clinical trial in the last 4 weeks

• Participant has a history of heart problems such as congestive heart failure, angina, heart attack or stroke in the last 3 months

• Participant is taking growth hormone or growth hormone inhibitors

• If female, participant is pregnant or breastfeeding

• Participant is human immunodeficiency virus (HIV) positive

• Participant has a history of hepatitis B or C