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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Yakult Honsha Co., LTD
Study ID
NCT00364143
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2006
Status verified
Jul 2019
Completion
Jun 30, 2011

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Incidence of dose-limiting toxicity within 28 days of treatment administration for patients with UGT1A1*28 genotype (wt/wt and wt/*28)

Locations (2)

FacilityCityStateZIPSite coordinators
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6307-

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