Study Complete
Sponsor ID
20101351
Study Evaluating Orally Administered AMG 900 in Adult Subjects with Acute Myeloid Leukemia
Study Details
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.
Protocol Summary
Primary Outcome Measures
Subject incidence of adverse events
Timeframe: 1 year
Subject incidence of dose limiting toxicities (DLTs)
Timeframe: 1 year
Maximum observed concentration of AMG 900
Timeframe: 1 year
Time to maximum observed concentration of AMG 900
Timeframe: 1 year
Area under the plasma concentration-time curve (AUC) of AMG 900
Timeframe: 1 year
Half life of AMG 900
Timeframe: 1 year
Secondary Outcome Measures
Objective response as per Cheson Response Criteria
Timeframe: 1 year
Change in the number of p-Histone H3 positive cells from baseline
Timeframe: 1 year
Locations
Location
Research Site
Houston, TX, United States, 77030
Status
Recruiting
Location
Research Site
Stony Brook, NY, United States, 11794
Status
Recruiting
Location
Research Site
Cleveland, OH, United States, 44195
Status
Recruiting