This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML),
chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will
initially evaluate the safety and tolerability of APG-115 as a single agent in Part 1,
followed by a combination of APG-115 + 5-azacitidine (5-AZA) in Part 2.
Part 1: Dose escalation of APG-115 will use standard 3+3 design. APG-115 is administered
orally once daily (QD) on Day 1-5 every 28-day cycle. The starting target dose is 100 mg
(dose level; DL1) and will be increased in subsequent cohorts to 150 mg (DL2), 200 mg (DL3),
and 250 mg (DL4), accordingly.
Part 2: Dose escalation of APG-115 in combination with 5-AZA will use standard 3+3 design.
5-AZA is administered at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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