Brief Summary
The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN).
Intervention / Treatment
- Drug: BGB-11417
- Drug: Azacitidine
- Drug: Posaconazole
- Drug: BGB-11417
- Drug: BGB-11417
Inclusion Criteria:
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- MDS
- MDS/MPN
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Adequate organ function defined as:
- Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
- Adequate liver function
- Life expectancy of > 12 weeks.
- Ability to comply with the requirements of the study.