drugset / Trial / NCT02440568
AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients
Phase 1/2
Terminated
22 enrolled
University of Illinois at Chicago
Teva Pharmaceuticals USA · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).
Timeline
- Start
- 2015-06-05
- Primary completion
- 2018-11-30
- Completion
- 2018-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omacetaxine | Unknown | 0.625 mg/m2 | Subcutaneous |
| Subject | Omacetaxine | Unknown | 1.25 mg/m2 | Subcutaneous |
| Subject | Omacetaxine | Unknown | 2 mg/m2 | Subcutaneous |
| Subject | Omacetaxine | Unknown | 3 mg/m2 | Subcutaneous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |