Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454142
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2007-03-27
Brief Title:
Pazopanib Hydrochloride in Treating Patients With Stage IV or Recurrent Nasopharyngeal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GW786034 Pazopanib in Asian Patients With RecurrentMetastatic Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-01
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 studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer Pazopanib hydrochloride 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 Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma
II Determine the progression-free survival of patients treated with this drug III Determine the toxicity of this drug in these patients IV Determine the effect of this drug on angiogenesis inhibition using dynamic contrast-enhanced computed tomography CT scan
V Determine the pharmacokinetic profile of this drug in these patients VI Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit rate and pharmacokinetics
OUTLINE
Patients receive pazopanib hydrochloride orally PO once daily QD on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically for up to 12 months
I Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma
II Determine the progression-free survival of patients treated with this drug III Determine the toxicity of this drug in these patients IV Determine the effect of this drug on angiogenesis inhibition using dynamic contrast-enhanced computed tomography CT scan
V Determine the pharmacokinetic profile of this drug in these patients VI Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit rate and pharmacokinetics
OUTLINE
Patients receive pazopanib hydrochloride orally PO once daily QD on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically for up to 12 months
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 |
|---|---|---|---|
| 7623 | OTHER | CTEP | None |
| NCI-2009-00197 | REGISTRY | None | None |
| CDR0000537520 | REGISTRY | None | None |
| CTRG-NP052506 | OTHER | None | None |
| NCC-06-01 | OTHER | None | None |