Neoadjuvant Pazopanib: A Phase II Study to Evaluate the Effect on Disease Response and Recurrence and to Establish Predictive Biomarkers of Drug Activity in Renal Cell Carcinoma
The primary objective of this study is to determine the objective response rate Complete
Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 12 weeks as
defined via RECIST1.1. The investigators will also estimate the recurrence free survival
(RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and
characterize the safety issues. Finally, this study also includes a number of exploratory
analyses designed to evaluate potential correlations between RFS and; serum levels of
cytokine and angiogenesis factor (CAF).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
Determine the objective response rate (CR+PR) using RECIST 1.1 at 12 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma
12 weeks after neoadjuvant treatment
No
Kimryn Rathmell, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
LCCC 1028
NCT01361113
May 2011
June 2015
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |
Carolinas HealthCare System | Charlotte, North Carolina |
Medical University of South Carolina (MUSC) | Charleston, South Carolina 29425 |
Weill Cornell Medical College | New York, New York 10021 |
North Carolina Cancer Hospital (UNC) | Chapel Hill, North Carolina 27599 |