NCT00542958

Study of NK012 in Patients With Refractory Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Nippon Kayaku Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	NK012	9.0, 12.0, 16.0, 21.0, 28.0 mg/m\^2, and to be determined. Intravenous infusion

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-04-01
• Completion: 2011-12-01
• First posted: 2007-10-12
• Last updated: 2019-10-28

Locations

1 site across 1 country: United States