The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients. Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.
All patients receive background treatment with docetaxel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Intravenous route
Intravenous route
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
Sanofi-Aventis Administrative Office
Berlin, Germany
ECG parameters (QTcF interval)
Time frame: Cycle 1 and Cycle 3
Other ECG parameters
Time frame: Cycle 1 and Cycle 3
Clinical safety (adverse events, serious adverse events)
Time frame: maximum of 15 cycles
Pharmacokinetic parameters
Time frame: Cycle 1 and Cycle 3
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Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Bucharest, Romania
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)