An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVENTM in Subjects With Cancer Who Also Have Impaired Renal Function
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.
United States: Food and Drug Administration
|Alexandria, Minnesota 56308|
|Albany, Georgia 31701|
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