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Study of the Safety and Pharmacokinetics of IMC-3G3 in Japanese Patients With Solid Tumors

Metastasis Clinical Trial

Official title:
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

Clinical Trial Summary

Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially receive intravenous (I.V.) IMC-3G3 once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). After the first cycle, patients experiencing an overall response of complete response (CR), partial response (PR), or stable disease (SD) will continue to receive IMC-3G3 at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01199822
Study type Interventional
Source ImClone LLC
Contact
Status Completed
Phase Phase 1
Start date September 2010
Completion date January 2012
View Details
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