Trials / Active Not Recruiting
Active Not RecruitingNCT02942290
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 129 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azacitidine | Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 \& Days 1-2 of Week 2 of 28 day cycle. |
| DRUG | Venetoclax | Oral; Tablet |
Timeline
- Start date
- 2017-01-12
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2016-10-24
- Last updated
- 2025-08-05
Locations
37 sites across 7 countries: United States, Australia, Canada, France, Germany, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02942290. Inclusion in this directory is not an endorsement.