Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052832
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2003-01-24
Brief Title:
Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2015-09
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:
RATIONALE Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia
PURPOSE Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia
PURPOSE Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia
Detailed Description:
OBJECTIVES
Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol
Determine the toxicity profile of this drug in these patients
Determine the time to progression and overall survival of patients treated with this drug
OUTLINE Patients receive oral doxercalciferol daily for 12 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 41 patients will be accrued for this study
Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol
Determine the toxicity profile of this drug in these patients
Determine the time to progression and overall survival of patients treated with this drug
OUTLINE Patients receive oral doxercalciferol daily for 12 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 41 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SMPHMEDICINE | OTHER | UW Madison | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| HO02403 | OTHER | None | None |
| 2002-184 | OTHER | None | None |
| A534260 | OTHER | None | None |