NCT01199822

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

A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-3G3 Administered in a 2-week, or 3-week Schedule to Japanese Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignancy
• Metastasis

Interventions

Type	Name	Description
BIOLOGICAL	Olaratumab	Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-09-13
• Last updated: 2017-04-14
• Results posted: 2017-04-14

Locations

1 site across 1 country: Japan