NCT00364143

Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors

A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yakult Honsha Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is safe and effective in the treatment of advanced solid tumors.

Detailed description

This is a Phase I dose-escalation study of intravenous administration of IHL-305 in patients with advanced solid tumors. Patients will receive IHL-305 as an intravenous infusion over 60 minutes on Day 1 followed by a 27-day observation period for a total of 28 days (4 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	IHL-305 (irinotecan liposome injection)

Timeline

• Start date: 2006-09-01
• Completion: 2011-06-01
• First posted: 2006-08-15
• Last updated: 2019-07-05

Locations

2 sites across 1 country: United States