Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard Therapy

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

March 31, 2009

Study Completion Date

November 30, 2009

Conditions
Advanced Solid Tumors
Interventions
BIOLOGICAL

IMC-18F1

Cohorts 1-4 will receive IMC-18F1 intravenously for 4 weekly infusions, followed by a 2-week observation period. Cohort 5 will receive IMC-18F1 intravenously every other week for the first 6 weeks of therapy. Cohort 6 will receive IMC-18F1 every 3 weeks for the first 6 weeks for therapy. The starting dose in Cohort 1 will be 2mg/kg. The maximum dose of IMC-18F1 will not exceed 16mg/kg administered every week, 15mg/kg administered every other week, and 20mg/kg administered every 3 weeks. Dose escalation of 100% (2 x previous dose) if no dose limiting toxicities (DLTs) are observed in the first three patients within a cohort during the initial 6-week therapy period. Dose escalation increment will be reduced to 50% (1.5 x previous dose) following the occurrence of either grade 2 or higher AEs in 2 or more patients that are possibly, probably, or definitely-related to study medication or one DLT during the initial 6-week therapy period. No intrapatient dose escalation is allowed.

Trial Locations (2)

44106

ImClone Investigational Site, Cleveland

48201

ImClone Investigational Site, Detroit

All Listed Sponsors
lead

Eli Lilly and Company

INDUSTRY

NCT00782002 - Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard Therapy | Biotech Hunter | Biotech Hunter