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Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS

NCT03564873 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-11

No results posted yet for this study

Summary

This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine.

Conditions

  • High Grade Myelodysplastic Syndromes

Interventions

DRUG

Omacetaxine

Phase I is a dose escalation phase. Patients will be enrolled into one of three cohorts to receive omacetaxine subcutaneously (0.5, 0.75, 1.0, or 1.25 mg/m2) twice daily on days 1 to 7.

DRUG

Azacitidine

Azacitidine will be given at the standard dose and schedule, 75 mg/m2 once daily, on days 1 to 7. The patients will then be monitored for 21 more days ( to complete one 28 day cycle) but no more medication will be administered during those 21 days.

DRUG

Omacetaxine

Phase II is a maximum tolerated dose phase. Phase I will determine the maximum tolerated dose (highest amount that can be safely administered). Patients will receive omacetaxine subcutaneously at the maximum tolerated dose (0.5, 0.75, 1.0, or 1.25 mg/m2) twice daily on days 1 to 7.

DRUG

Azacitidine

Azacitidine will be given at the standard dose and schedule, 75 mg/m2 once daily, on days 1 to 7. The patients will then be monitored for 21 more days ( to complete one 28 day cycle) but no more medication will be administered during those 21 days.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Daniel Pollyea, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2025-10-07
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03564873 on ClinicalTrials.gov