Ignite Creation Date:
2024-05-06 @ 12:25 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01573247
Status:
TERMINATED
Last Update Posted:
2016-03-25
First Post:
2012-03-28
Brief Title:
Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia
Sponsor:
Akinion Pharmaceuticals AB
Organization:
Akinion Pharmaceuticals AB
Study Overview
Official Title:
A Phase 12 Open-Label Multi-Center Dose Escalation Safety and Tolerability Study of AKN-028 in Patients With Acute Myelogenous Leukemia AML
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
During the study two patients have experienced serious liver events related to AKN-028 The risk-benefit balance was judged to be negative
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 12 study consists of two parts The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia AML The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-003285-33 | EUDRACT_NUMBER | None | None |