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Study of NK012 in Patients With Refractory Solid Tumors

Cancer Clinical Trial

Official title:
A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors

Clinical Trial Summary

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors

Clinical Trial Description

This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00542958
Study type Interventional
Source Nippon Kayaku Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date March 2007
Completion date December 2011
View Details
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