A Phase 2 Study of GW786034 (Pazopanib) With or Without Bicalutamide in Hormone Refractory Prostate Cancer
I. To determine the therapeutic activity of GW786034 (pazopanib hydrochloride) with and
without bicalutamide in the treatment of hormone-refractory prostate cancer using
I. To estimate objective tumor response in patients with measurable disease. II. To estimate
the median time to progression. III. To investigate the safety and tolerability of GW786034
with and without bicalutamide.
IV. To estimate the median duration of PSA-response. V. To determine the steady state levels
of GW786034 with and without bicalutamide.
VI. To investigate the correlation between prior exposure to bicalutamide and non-steroidal
anti-androgens with response and survival outcomes.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28.
ARM II: Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive
bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Courses in both arms repeat every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed up every 4 weeks for 12 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response rate
Up to 12 weeks
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration