This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Severe renal impairment-the dose to be administered will be based on the interim analyses of safety and pharmacokinetics in subjects with moderate renal impairment (Cohort 1).
Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.
Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.
Unnamed facility
Duarte, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Detroit, Michigan, United States
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.
Time frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of HALAVEN in subjects with moderate or severe renal impairment, as well as in those with normal renal function.
Safety data that will be evaluated include adverse events, clinical laboratory results, physical examination results, ECG, and vital signs
Time frame: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
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Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
New Brunswick, New Jersey, United States
Unnamed facility
The Bronx, New York, United States
Unnamed facility
San Antonio, Texas, United States