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

2014-07-23 21:35:32 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cancer

Intervention

IHL-305 (irinotecan liposome injection)

Location

Vanderbilt-Ingram Cancer Center
Nashville
Tennessee
United States
37232-6307

Status

Recruiting

Source

Yakult Honsha Co., LTD

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:32-0400

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