A Phase II Safety and Efficacy Study With the VEGF Receptor Tyrosine Kinase Inhibitor GW786034 in Patients With Metastatic Urothelial Cancer
I. Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in
patients with metastatic urothelial cancer.
I. Evaluate the pharmacokinetics of pazopanib hydrochloride in these patients. II. Evaluate
pre- and post-treatment changes in circulating endothelial cells, monocytes and platelets,
and angiogenesis-related factors in these patients.
OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once
daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or
Patients undergo blood collection periodically for correlative studies and pharmacological
studies. Samples are analyzed for vascular endothelial growth factor (VEGF) and soluble VEGF
receptor II concentration via ELISA. Circulating endothelial cells are also measured.
After completion of study treatment, patients are followed for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])
Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria: A Complete Response (CR) requires the disappearance of all target lesions. A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.
United States: Food and Drug Administration
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Mayo Clinic Cancer Research Consortium||Rochester, Minnesota 55905|