Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471536
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2007-05-08
Brief Title:
Pazopanib in Treating Patients With Metastatic Urothelial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Safety and Efficacy Study With the VEGF Receptor Tyrosine Kinase Inhibitor GW786034 in Patients With Metastatic Urothelial Cancer
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying the side effects and how well pazopanib works in treating patients with metastatic urothelial cancer Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in patients with metastatic urothelial cancer
SECONDARY OBJECTIVES
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 unacceptable toxicity
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
I Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in patients with metastatic urothelial cancer
SECONDARY OBJECTIVES
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 unacceptable toxicity
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
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000543460 | None | None | None |
| NCI-2009-00203 | REGISTRY | None | None |
| MAYO-MC0553 | None | None | None |
| MC0553 | OTHER | None | None |
| 7661 | OTHER | None | None |
| N01CM62205 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62205 |