A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
BeiGene
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) .
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key 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. Key Exclusion Criteria: 1. A diagnosis of acute promyelocytic leukemia. 2. Hist…
Interventions
- DrugBGB-11417
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
- DrugAzacitidine
Intravenous or subcutaneous administration for 7 days.
- DrugPosaconazole
Oral administration for 8 days on second cycle only.
- DrugBGB-11417
Oral administration for 28 days on a 28-day cycle.
- DrugBGB-11417
Oral administration for 10, 14 or 21 days on a 28-day
Locations (46)
- City of Hope National Medical CenterDuarte, California
- Tampa General HospitalTampa, Florida
- Upmc Hillman Cancer Center(Univ of Pittsburgh)Pittsburgh, Pennsylvania
- Md Anderson Cancer CenterHouston, Texas
- Medical College of WisconsinMilwaukee, Wisconsin
- Concord Repatriation General HospitalConcord, New South Wales