A phase II study of GW786034 (pazopanib) with or without bicalutamide in patients with castration-resistant prostate cancer.

ABSTRACT:

Introduction

Pazopanib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor. In this randomized, open label phase II study, pazopanib alone or in combination with bicalutamide was evaluated in patients with chemotherapy-naive castration-resistant prostate cancer (CRPC).

Patients and methods

Patients received either pazopanib 800 mg daily (arm A) or pazopanib 800 mg plus bicalutamide 50 mg daily (arm B). A 2-stage study design was used, and the primary endpoint was prostate-specific antigen (PSA) response rate (defined as a confirmed ≥ 50% decline from baseline).

Results

A total of 23 patients (arm A, 10; arm B, 13) were accrued. The main grade 3+ toxicities were hypertension, fatigue, decreased lymphocytes, and increased alanine tra

SUBMITTER: Sridhar SS 

PROVIDER: S-EPMC4259891 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature