drugset / Trial / NCT01199822

Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors

NCT01199822

Phase 1 Completed 16 enrolled Eli Lilly and Company
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

EvaluationDrugModalityDoseRoute
Subject Olaratumab Monoclonal antibody 10 mg/kg Intravenous
Subject Olaratumab Monoclonal antibody 15 mg/kg Intravenous
Subject Olaratumab Monoclonal antibody 20 mg/kg Intravenous