drugset / Trial / NCT02520011
Alvocidib Biomarker-driven Phase 2 AML Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow.
Timeline
- Start
- 2016-03-14
- Primary completion
- 2020-02-12
- Completion
- 2020-02-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | alvocidib | Small molecule | 30 mg/m2 | Intravenous |
| Subject | alvocidib | Small molecule | 60 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | Intravenous |
| Background | Mitoxantrone | Small molecule | 40 mg/m2 | Intravenous |