drugset / Trial / NCT01007032

A Study of IMC-A12 in Advanced Solid Tumors

NCT01007032

SequentialOpen-labelTreatment

Summary

In this study, participants will initially receive intravenous (IV) cixutumumab (IMC-A12) every 2 weeks or every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing a best overall response of complete response, partial response, or stable disease will continue to receive cixutumumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met. Participants will be enrolled at one study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan. Approximately 20-30 participants are anticipated.

Timeline

Start
2009-11
Primary completion
2012-12
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cixutumumab Monoclonal antibody 6 mg/kg Intravenous
Subject Cixutumumab Monoclonal antibody 10 mg/kg Intravenous
Subject Cixutumumab Monoclonal antibody 15 mg/kg Intravenous
Subject Cixutumumab Monoclonal antibody 20 mg/kg Intravenous

Indications