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

An Open-Label, Dose Escalation Phase I Trial of MK-0646 Given as a Once Weekly, Every Other Week, or Every Three Week Infusion in Patients With Advanced Solid Tumors and Multiple Myeloma

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.

Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.

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