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

NCT03459859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-12-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Justin Watts, MD

    lead OTHER

Principal Investigators

  • Justin Watts, MD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2021-06-25
Completion
2021-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459859 on ClinicalTrials.gov