A Phase I/ II Trial of Pazopanib Alternating With Bevacizumab in Treatment-Naive Metastatic Clear Cell Renal Cell Carcinoma Patients
PRIMARY OBJECTIVES:
I. To determine the safe phase II dose of this novel regimen. (Phase I) II. To determine the
median progression free survival (PFS) from this novel regimen. (Phase II)
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity of the proposed regimen. (Phase I) II. To evaluate
the response rate. (Phase I) III. To evaluate the pharmacokinetics of pazopanib (pazopanib
hydrochloride). (Phase I) IV. To evaluate the vascular endothelial growth factor (VEGF)
levels and myeloid derived suppressor cell (MDSC) levels at various time points and
correlate with response. (Phase I) V. To evaluate the safety and toxicity of this new
regimen. (Phase II) VI. To evaluate the VEGF levels, interleukin (IL)-8 levels and MDSC
levels at various time points and correlate with outcome. (Phase II) VII. To evaluate the
PFS rate at 12 months. (Phase II) VIII. To evaluate overall survival. (Phase II)
OUTLINE: This is a dose-escalation study.
Patients receive pazopanib hydrochloride orally (PO) on days 1-28 and bevacizumab
intravenously (IV) over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Optimal phase II dose defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity (DLT) assessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Up to 140 days
Yes
Saby George
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 191711
NCT01684397
October 2012
Name | Location |
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Roswell Park Cancer Institute | Buffalo, New York 14263 |