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2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-31 @ 1:27 AM
Study NCT ID:
NCT01599832
Status:
TERMINATED
Last Update Posted:
2017-06-08
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Measuring Effects of Pazopanib Hydrochloride in Patients With Metastatic Kidney Cancer
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
DCE-MRI as Pazopanib Biomarker in Metastatic Renal Cancer
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00676 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |