Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
Completed · Phase 1
Conditions studied: Cancer, Hematologic Malignancies, Leukemia, Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT01380756
- Run by
- Amgen
- People needed
- 35
- Starts
- 2011-10-04
- Expected to finish
- 2014-09-04
- Last updated by the study team
- 2017-11-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women ≥ 18 years old
- Pathologically documented, definitively diagnosed AML that has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy
- Must consent to undergo bone marrow biopsies per schedule of assessments
You may not qualify if…
- White blood cell greater than 20,000 uL
- History of or active central nervous system leukemia
- Prior allogeneic bone marrow transplant
- Subject will not be available for protocol-required study visits or procedures
- Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment
Where it is running
- Research Site — Stony Brook, New York, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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