Conditions: Solid Tumor Multiple Myeloma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 80
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W). arm 2: Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W. arm 3: Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W. arm 4: Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W. arm 5: Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W. arm 6: Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W. arm 7: Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W. arm 8: Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W. arm 9: Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W. arm 10: Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W). arm 11: Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion1 time every 3 weeks (Q3W).

Interventions: intervention 1: Dalotuzumab
Intervention descriptions: intervention 1: IV infusion

Protocol document: