drugset / Trial / NCT01199822
Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing an overall response of complete response (CR), partial response (PR), or stable disease (SD) will continue to receive olaratumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met.
Timeline
- Start
- 2010-09
- Primary completion
- 2012-01
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaratumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 20 mg/kg | Intravenous |