CI

At a glance

ClinicalIndex Comparison Record
Phase 1Terminated· 2 enrolled
Drug / intervention
Omacetaxine +1 moredrug
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/NCT02141477
NCT02141477Phase 1Terminated
Terminated
CompareCT.gov

A Phase II Study of Omacetaxine (OM) and Decitabine (DAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted May 19, 2014·Updated Feb 13, 2018

In Brief

A Phase 1 clinical trial evaluating Omacetaxine and Decitabine for Leukemia. Terminated early, enrolled 2 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.

Study Details

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

Timeline

Phase 1TerminatedFinished
201520162017201820192020202120222023202420252026
First PostedMay 19, 2014
Enrollment StartMay 6, 2015
Primary CompletionJun 22, 2017
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 12.1 years ago

Interventions

Omacetaxinedrug

Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.

Decitabinedrug

Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle. Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.