The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be administered safely in combination. The Phase II part of the study will not be progressed as documented in Protocol Amendment 01.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
oral pazopanib once daily (Phase I starting dose 800 mg)
paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Sutton, Surrey, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, United Kingdom
Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status)
Time frame: at least one cycle of treatment (3 weeks)
Phase I: paclitaxel and pazopanib pharmacokinetics
Time frame: Cycle 1 and Cycle 2 PK sampling
Phase I: clinical activity
Time frame: at least 6 weeks
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