Trials / Completed
CompletedNCT02632721
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Decitabine | |
| DRUG | BI 836858 |
Timeline
- Start date
- 2016-06-16
- Primary completion
- 2023-01-16
- Completion
- 2023-01-16
- First posted
- 2015-12-17
- Last updated
- 2024-03-19
- Results posted
- 2024-03-19
Locations
14 sites across 4 countries: United States, Germany, Italy, Spain
Source: ClinicalTrials.gov record NCT02632721. Inclusion in this directory is not an endorsement.