A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Status:
Completed
Trial end date:
2008-11-05
Target enrollment:
Participant gender:
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.