drugset / Trial / NCT02842827
A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)
Phase 1/2
Completed
45 enrolled
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Some participants may also receive all-trans retinoic acid (ATRA; also known as tretinoin and Vesanoid®) in combination with bomedemstat. This study investigates the following: * The safety and tolerability of bomedemstat with and without ATRA * The pharmacodynamic effect of different doses of bomedemstat and treatment durations, as well as bomedemstat administered in combination with ATRA * The pharmacokinetics of bomedemstat with and without ATRA
Timeline
- Start
- 2016-10-06
- Primary completion
- 2018-10-30
- Completion
- 2018-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bomedemstat | Small molecule | 0.75 mg/kg | Oral |
| Subject | Bomedemstat | Small molecule | 1.5 mg/kg | Oral |
| Subject | Bomedemstat | Small molecule | 3 mg/kg | Oral |
| Subject | Bomedemstat | Small molecule | 6 mg/kg | Oral |
| Subject | Tretinoin | Small molecule | 45 mg/m2 | Oral |