Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT01599832
Brief Summary:
The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride) (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure, and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new blood vessel formation. The use of pazopanib described in this study is a standard of care, but the additional MRI and blood tests that will be performed are experimental
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine whether a K\^trans rise from nadir is predictive of subsequent tumor growth.
SECONDARY OBJECTIVES:
I. To determine the association between changes in mean ambulatory blood pressure measurements, K\^trans, and tumor size changes with pazopanib therapy.
II. To determine the association between changes in soluble vascular endothelial growth factor receptor 2 (sVEGFR2) measurements, K\^trans, and tumor size changes with pazopanib therapy.
TERTIARY OBJECTIVES:
I. To explore previously described single nucleotide polymorphisms (SNP's) as pharmacogenomic biomarkers.
II. To model tumor growth kinetics using radiologic tumor size measurements. III. To explore other serum and plasma based putative biomarkers of vascular endothelial growth factor (VEGF) pathway inhibition.
OUTLINE:
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study:
NCT01599832
Study Brief:
Protocol Section:
NCT01599832