CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Omacetaxinedrug
Likely dose
Omacetaxine 1.25 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02159872
NCT02159872Phase 2Completed
CompareCT.gov

A Phase II Study of Omacetaxine (OM) in Patients With Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) Post Hypomethylating Agent (HMA) Failure

M.D. Anderson Cancer Center·interventional·Posted Jun 10, 2014·Updated Jun 9, 2021

In Brief

A Phase 2 clinical trial evaluating Omacetaxine for Leukemia. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The goal of this clinical research study is learn if omacetaxine can help to control myelodysplastic syndrome (MDS). The safety of this drug will also be studied. This is an investigational study. Omacetaxine is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). It is investigational to use omacetaxine in patients with MDS. The study doctor can explain how the study drug is designed to work. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsTeva Pharmaceuticals USA

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2014
Enrollment StartMay 18, 2015
Primary CompletionApr 14, 2020
TodayJul 1, 2026
Enrollment to primary: 4.9 yearsPosted 12.1 years ago

Interventions

Omacetaxinedrug

1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle.