Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509587
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2007-07-30
Brief Title:
Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GW786034 Pazopanib in Patients With Recurrent andor Metastatic Invasive Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-07
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 how well giving pazopanib works in treating patients with recurrent or metastatic invasive breast 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 OBJECTIVE
I To determine the antitumor activity of pazopanib in terms of objective response rate partial and complete response in patients with recurrent or metastatic invasive breast cancer
SECONDARY OBJECTIVES
I To determine the duration of objective response rate and duration of stable disease
II To determine 6-month progression-free and median and overall survival rates in patients treated with this drug
III To document the safety and tolerability of this drug in these patients
OUTLINE This is a multicenter open label study
Patients receive oral pazopanib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Blood samples are collected at baseline and at 1 4 and 8 weeks for correlative laboratory studies Blood samples are evaluated for the following tumor markers by ELISA VEGF bFGF sFLT-1 sTIE-2 sE-Selectin VCAM-1 PDGF-AA PDGF-AB and PDGF-BB TSP-1 in plasma is measured by Accucyte competitive immunoassay
After completion of study treatment patients are followed every 3 months
I To determine the antitumor activity of pazopanib in terms of objective response rate partial and complete response in patients with recurrent or metastatic invasive breast cancer
SECONDARY OBJECTIVES
I To determine the duration of objective response rate and duration of stable disease
II To determine 6-month progression-free and median and overall survival rates in patients treated with this drug
III To document the safety and tolerability of this drug in these patients
OUTLINE This is a multicenter open label study
Patients receive oral pazopanib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Blood samples are collected at baseline and at 1 4 and 8 weeks for correlative laboratory studies Blood samples are evaluated for the following tumor markers by ELISA VEGF bFGF sFLT-1 sTIE-2 sE-Selectin VCAM-1 PDGF-AA PDGF-AB and PDGF-BB TSP-1 in plasma is measured by Accucyte competitive immunoassay
After completion of study treatment patients are followed every 3 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 |
|---|---|---|---|
| N01CM62203 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62203 |
| NCI-2009-00199 | REGISTRY | None | None |
| CDR0000557347 | None | None | None |
| PHL-057 | None | None | None |
| PHL-057 | OTHER | None | None |
| 7638 | OTHER | None | None |