drugset / Trial / NCT03459859
Pevonedistat and Low Dose Cytarabine in Adult Patients With AML and MDS
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The investigators hypothesize that the combination of Pevonedistat/Low-Dose Cytarabine (LDAC) therapy will be tolerable, that a recommended phase 2 dose of Pevonedistat in combination with LDAC will be identified, and that the combination therapy will show evidence of clinical activity in adult patients with Relapsed/Refractory Acute Myelogenous Leukemia (AML) and Advanced Myelodysplastic Syndromes (MDS).
Timeline
- Start
- 2018-05-21
- Primary completion
- 2021-06-25
- Completion
- 2021-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pevonedistat | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Pevonedistat | Small molecule | 15 mg/m2 | Intravenous |
| Subject | Pevonedistat | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Pevonedistat | Small molecule | 25 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 20 mg/m2 | Subcutaneous |