This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule.
Research Site
Stony Brook, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Houston, Texas, United States
Subject incidence of adverse events
Time frame: 1 year
Subject incidence of dose limiting toxicities (DLTs)
Time frame: 1 year
Maximum observed concentration of AMG 900
Time frame: 1 year
Time to maximum observed concentration of AMG 900
Time frame: 1 year
Area under the plasma concentration-time curve (AUC) of AMG 900
Time frame: 1 year
Half life of AMG 900
Time frame: 1 year
Objective response as per Cheson Response Criteria
Time frame: 1 year
Change in the number of p-Histone H3 positive cells from baseline
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.