An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVENTM in Subjects With Cancer Who Also Have Impaired Renal Function
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
The primary analysis will be conducted using the dose-normalized primary PK parameters (AUC0-inf, AUC0-last, and Cmax) respectively. Relationships between each individual PK parameter and renal function (creatinine clearance) will be analyzed by linear regression models using the PK parameter as the dependent variable and renal function as the independent variable.
Halaven will be measured on Day 1 and 8 of a 21 day cycle.
No
United States: Food and Drug Administration
E7389-A001-106
NCT01418677
August 2011
Name | Location |
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Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Austin, Texas 78705 | |
Hackensack, New Jersey 07601 |