drugset / Trial / NCT01007032
A Study of IMC-A12 in Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |