Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
Solid Tumor, Multiple Myeloma
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion1 time every 3 weeks (Q3W).