Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004047
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
1999-12-10
Brief Title:
Chemotherapy in Treating Patients Who Have Hematologic Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes Refractory Acute Leukemia Refractory or Transformed Chronic Lymphocytic Leukemia and Chronic Myelogenous Leukemia in Blastic Phase
Status:
COMPLETED
Status Verified Date:
2012-05
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of DX-8951f in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of DX-8951f in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of DX-8951f in patients with advanced myelodysplastic syndromes refractory acute myeloid or lymphocytic leukemia refractory or transformed chronic lymphocytic leukemia or chronic myelogenous leukemia in blastic phase II Evaluate the quantitative and qualitative toxic effects of this regimen and determine the duration and reversibility of these effects in these patients III Make a preliminary determination of the antileukemic activity of this regimen in these patients IV Evaluate the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive DX-8951f IV over 30 minutes daily for 5 days Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of DX-8951f until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 20-25 evaluable patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive DX-8951f IV over 30 minutes daily for 5 days Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of DX-8951f until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 20-25 evaluable patients will be accrued for this study
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-V99-1556 | None | None | None |
| DAIICHI-8951A-PRT014 | None | None | None |
| MDA-ID-99013 | None | None | None |