Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274248
Status:
COMPLETED
Last Update Posted:
2008-02-11
First Post:
2006-01-09
Brief Title:
MLN518 in Combination With Standard Induction Chemo for Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Millennium Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Study of MLN518 Given in Combination With Standard Induction Chemotherapy for the Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2008-02
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 is a phase 1 open-label multicenter study investigating the use of MLN518 in combination with standard chemotherapy to patients with newly diagnosed AML Two dose levels of MLN518-200 mg and 400 mg given orally twice a day are planned for sequential evaluation in separate groups of patients Patients assigned to the 400 mg dose level given orally twice a day of MLN518 will potentially have their dose of MLN518 adjusted on the basis of MLN518 plasma concentrations measured during the first 3 days of induction therapy All patients will receive initial induction chemotherapy with cytarabine 200 mgm2day by CIVI on Days 1 through 7 and with daunorubicin 60 mgm2day by intravenous IV push IV infusion if borderline cardiac function is detected on Days 1 through 3 73 An abbreviated cytarabine and daunorubicin regimen 52 will also be used when the initial remission induction therapy fails to clear the bone marrow of blast cells as typically detected on the Day 15 bone marrow and a second attempt at remission induction is indicated Patients who achieve a complete remission CR will receive consolidation therapy with HiDAC standard or modified in combination with continued MLN518 treatment Patients remaining in continuous CR after completion of their last cycle of consolidation therapy will be permitted to continue treatment with single-agent MLN518 for 6 months thereafter
Detailed Description:
None
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