drugset / Trial / NCT00635778
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/mL.
Timeline
- Start
- 2006-08-07
- Primary completion
- 2008-11-05
- Completion
- 2008-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dalotuzumab | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Subject | dalotuzumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | dalotuzumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | dalotuzumab | Monoclonal antibody | 15 mg/kg | Intravenous |