Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478426
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2007-05-23
Brief Title:
Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-02
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 how well sunitinib malate works in treating patients with endometrial cancer that has come back after a period of improvement recurrent or has spread to other places in the body metastatic Sunitinib 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 To assess the objective response rate of recurrent or metastatic endometrial cancer to sunitinib sunitinib malate
II To assess the frequency of prolonged stable disease as defined by percentage of patients alive and free from progressive disease at 6 months in patients with recurrent or metastatic endometrial cancer treated with sunitinib
SECONDARY OBJECTIVES
I To assess time-to- progression median overall survival and rate of one-year survival in patients with recurrent or metastatic endometrial cancer treated with sunitinib
II To assess the toxicity associated with sunitinib in patients with recurrent or metastatic endometrial cancer
OUTLINE
Patients receive sunitinib malate orally PO once daily QD on days 1-28 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
After the completion of study treatment patients are followed up at 4 weeks and then every 3 months until relapse
I To assess the objective response rate of recurrent or metastatic endometrial cancer to sunitinib sunitinib malate
II To assess the frequency of prolonged stable disease as defined by percentage of patients alive and free from progressive disease at 6 months in patients with recurrent or metastatic endometrial cancer treated with sunitinib
SECONDARY OBJECTIVES
I To assess time-to- progression median overall survival and rate of one-year survival in patients with recurrent or metastatic endometrial cancer treated with sunitinib
II To assess the toxicity associated with sunitinib in patients with recurrent or metastatic endometrial cancer
OUTLINE
Patients receive sunitinib malate orally PO once daily QD on days 1-28 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
After the completion of study treatment patients are followed up at 4 weeks and then every 3 months until relapse
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 |
|---|---|---|---|
| NCI-2009-00210 | REGISTRY | None | None |
| PHL-062 | None | None | None |
| CDR0000513153 | None | None | None |
| 7713 | OTHER | None | None |
| 7713 | OTHER | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62203 | NIH | None | None |
| N01CM62209 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62209 |