A Study of BGB-11417 in Participants With Myeloid Malignancies
NCT04771130 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2026-04-23
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) .
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasm
Interventions
- DRUG
-
BGB-11417
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
- DRUG
-
Intravenous or subcutaneous administration for 7 days.
- DRUG
-
Posaconazole
Oral administration for 8 days on second cycle only.
- DRUG
-
BGB-11417
Oral administration for 28 days on a 28-day cycle.
- DRUG
-
BGB-11417
Oral administration for 10, 14 or 21 days on a 28-day
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-24
- Primary Completion
- 2028-02-08
- Completion
- 2028-02-08
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
- France
- Germany
- Italy
- New Zealand
- South Korea
- Spain
- United Kingdom
Study Locations
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