A Study of BGB-11417 in Participants With Myeloid Malignancies

NCT 04771130

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 

  • DrugBGB-11417
  • DrugAzacitidine
  • DrugPosaconazole
  • DrugBGB-11417
  • DrugBGB-11417

Inclusion Criteria:

  1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
    • AML, nonacute promyelocytic leukemia
    • MDS
    • MDS/MPN
  2. Eastern Cooperative Oncology Group performance status of 0 to 2.
  3. 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
  4. Life expectancy of > 12 weeks.
  5. Ability to comply with the requirements of the study.

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