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A Clinical Trial of Omacetaxine, Azacitidine, and Growth-Colony Stimulating Factor (G-CSF) for Myelodysplastic Syndromes (MDS)

NCT02835794 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-05-03

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and establish the maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory MDS.

Conditions

Interventions

DRUG

Omacetaxine

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

DRUG

Azacitidine

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

DRUG

G-CSF

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Sponsors & Collaborators

  • Teva Pharmaceutical Industries, Ltd.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Maxim N. Norkin, MD, PhD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02835794 on ClinicalTrials.gov