Trials / Completed
CompletedNCT03625505
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | tablet, oral |
| DRUG | Gilteritinib | tablet, oral |
Timeline
- Start date
- 2018-10-18
- Primary completion
- 2021-08-31
- Completion
- 2021-08-31
- First posted
- 2018-08-10
- Last updated
- 2021-09-14
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03625505. Inclusion in this directory is not an endorsement.