Trials / Completed
CompletedNCT04887857
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CC-486 | Specified dose on specified days |
| DRUG | Venetoclax | Specified dose on specified days |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2024-01-08
- Completion
- 2024-01-08
- First posted
- 2021-05-14
- Last updated
- 2024-02-12
Locations
10 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04887857. Inclusion in this directory is not an endorsement.