An early phase study which aims to find a dose, asses safety and tolerability of AKN-028 in Patients with Acute Myelogenous Leukemia (AML)

Registry ID
EUCTR2011-003285-33
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE2
Sponsor
Akinion Pharmaceuticals AB
Start date
2011-11-02
Last update
2026-08-16

Conditions

Summary

In Part 1, the primary objectives are: To examine the safety and tolerability of AKN-028 and to determine the recommended Phase 2 dose (RPTD) of AKN-028 for further evaluation in Part 2 in the same patient population; and To characterize the pharmacokinetic (PK) parameters for AKN-028 in patients with AML. In Part 2, the primary objective is to determine the overall remission rate (OR) defined as CR (complete remission) + CRi (CR with incomplete recovery) + PR (partial remission)

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