NCT03459859

Pevonedistat and Low Dose Cytarabine in Adult Patients With AML and MDS

An Open-Label, Dose Escalation, Phase 1 Study of PEVONEDISTAT, a Novel Inhibitor of the NEDD8-Activating Enzyme (NAE), in Combination With Low Dose Cytarabine (LDAC) in Adult Patients With Acute Myelogenous Leukemia (AML) and Advanced Myelodysplastic Syndromes (MDS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Justin Watts, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myelogenous Leukemia
• AML
• Advanced Myelodysplastic Syndromes
• MDS

Interventions

Type	Name	Description
DRUG	Pevonedistat	Administered intravenous (IV) infusion over one hour on Days 1, 3 and 5 of each cycle, after administration of LDAC per protocol.
DRUG	Cytarabine	Low dose Cytarabine (LDAC) administered subcutaneously (SC) daily for 10 days of every 28-day cycle.

Timeline

• Start date: 2018-05-21
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2018-03-09
• Last updated: 2021-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study