Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363974
Status:
COMPLETED
Last Update Posted:
2009-12-01
First Post:
2006-08-10
Brief Title:
Study of XIAP Antisense Given With Chemotherapy for RefractoryRelapsed AML
Sponsor:
Aegera Therapeutics
Organization:
Aegera Therapeutics
Study Overview
Official Title:
An Open-Label Phase III Study of XIAP Antisense AEG35156 Administered to Patients With RefractoryRelapsed AML in Combination With Chemotherapy
Status:
COMPLETED
Status Verified Date:
2009-11
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:
The purpose of this study is to determine if the drug called AEG35156 can be safely given to AML patients and whether it effectively reduces levels of a protein XIAP to increase the sensitivity of cancer cells to chemotherapy ara-C and idarubicin in patients with refractory or relapsed AML
Detailed Description:
This is a phase III single-arm open-label study to establish the recommended dose and activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse after an initial CR that lasted less than 6 months or primary refractory AML Fixed dose of idarubicin and ara-C will be given plus one of eight doses of AEG35156 12 24 48 75 110 165 250 and 350mgm2 A maximum of 54 patients will be treated in cohorts of size 3 starting at 12mgm2 and not skipping any untried dose level when escalating Following dose escalation approximately 20 patients will be treated at the best acceptable dose as determined by the method of Thall and Cook 2004
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 |
|---|---|---|---|
| PMH 05-0452-C | None | None | None |
| MDA 2005-0384 | None | None | None |