Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451048
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2007-03-20
Brief Title:
Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sunitinib Malate Sutent SU11248 in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
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 sunitinib works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth
Detailed Description:
OBJECTIVES
I Determine the overall response rate complete response partial response or hematological improvement in patients with intermediate-2 or high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia treated with sunitinib malate
II Determine the duration of response in patients treated with this drug III Determine the overall survival of patients treated with this drug IV Determine the progression-free survival of patients treated with this drug V Determine the time to disease progression in patients treated with this drug
VI Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 3-4 weeks and then monthly thereafter
I Determine the overall response rate complete response partial response or hematological improvement in patients with intermediate-2 or high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia treated with sunitinib malate
II Determine the duration of response in patients treated with this drug III Determine the overall survival of patients treated with this drug IV Determine the progression-free survival of patients treated with this drug V Determine the time to disease progression in patients treated with this drug
VI Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 3-4 weeks and then monthly thereafter
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 |
|---|---|---|---|
| PHL-063 | OTHER_GRANT | None | None |
| CDR0000535656 | OTHER_GRANT | None | None |
| N01CM62203 | NIH | N01CM62203 | httpsreporternihgovquickSearchN01CM62203 |