Trials / Recruiting
RecruitingNCT04771130
A Study of BGB-11417 in Participants With Myeloid Malignancies
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGB-11417 | Oral administration for 10, 21, 14 or 28 days on a 28-day cycle. |
| DRUG | Azacitidine | 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 |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2028-02-08
- Completion
- 2028-02-08
- First posted
- 2021-02-25
- Last updated
- 2026-04-14
Locations
46 sites across 10 countries: United States, Australia, China, France, Germany, Italy, New Zealand, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04771130. Inclusion in this directory is not an endorsement.