Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387426
Status:
TERMINATED
Last Update Posted:
2014-05-28
First Post:
2006-10-12
Brief Title:
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis
Status:
TERMINATED
Status Verified Date:
2013-10
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 sunitinib works in treating patients with idiopathic myelofibrosis Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells
Detailed Description:
PRIMARY OBJECTIVE
I Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate
SECONDARY OBJECTIVE
I Assess the safety of sunitinib malate in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral sunitinib malate once daily for 6 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks
I Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate
SECONDARY OBJECTIVE
I Assess the safety of sunitinib malate in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral sunitinib malate once daily for 6 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks
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-2009-00207 | REGISTRY | None | None |
| CDR0000504056 | None | None | None |
| 2006-0208 | None | None | None |
| 2006-0208 | OTHER | None | None |
| 7700 | OTHER | None | None |
| N01CM62202 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62202 |