Cancer, Hematologic Malignancies, Leukemia, Myeloid Leukemia
Conditions
Keywords
Amgen, Phase 1, Clinical Trial, Aurora kinase inhibitor, Open label, Oncology, Hematology
Brief summary
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.
Interventions
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).
DRUGArm 2- Dose Expansion
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.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Half life of AMG 900 | 1 year |
| Time to maximum observed concentration of AMG 900 | 1 year |
| Area under the plasma concentration-time curve (AUC) of AMG 900 | 1 year |
| Subject incidence of adverse events | 1 year |
| Subject incidence of dose limiting toxicities (DLTs) | 1 year |
| Maximum observed concentration of AMG 900 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in the number of p-Histone H3 positive cells from baseline | 1 year |
| Objective response as per Cheson Response Criteria | 1 year |
Countries
United States
Outcome results
None listed