To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
Sorafenib 200 mg orally BID interrupted dosing
Sorafenib 400 mg orally BID interrupted dosing
Bevacizumab 2.5 mg/kg intravenously
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Houston, Texas, United States
The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab
Time frame: 2 years
The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin
Time frame: 2 years
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Bevacizumab 5 mg/kg intravenously
Bevacizumab 7.5 mg/kg intravenously
Bevacizumab 10 mg/kg intravenously
Paclitaxel 200 mg/m² intravenously
Carboplatin AUC 6 intravenously