A Phase Ia/Ib, Open-Label, Multicentre, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 Administered Daily in Adult Patients With Recurrent or Refractory Acute Myelogenous Leukemia (AML)
A Phase Ia/Ib, Open-Label, Multicentre, Two-Part Study to Assess the Safety, Tolerability,
Pharmacokinetics and Efficacy of AZD1208 Administered Daily in Adult Patients with Recurrent
or Refractory Acute Myelogenous Leukemia (AML).
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Part A: Number of patients with dose limiting toxicities (DLTs) [Maximum Tolerated Dose (MTD) is defined as the maximum dose level below the dose level at which ≥ 33 % of at least 6 patients of a cohort experience DLTs during cycle 1.]
28 days (cycle 1)
Yes
Becker Hewes, MD
Study Director
Sponsor GmbH
Canada: Canadian Institutes of Health Research
D4510C00001
NCT01489722
February 2012
January 2015
Name | Location |
---|---|
Research Site | Beverly, Massachusetts |
Research Site | Abilene, Texas |