Omacetaxine for Myelodysplastic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Universtiy of Colorado Denver, Aurora, COMyelodysplastic SyndromeOmacetaxine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new combination of drugs to treat patients with MDS who have not responded to other treatments.

Eligible Conditions
  • Myelodysplastic Syndrome, High Grade

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Study start date to study end date, or death, whichever comes first, up to 4 years.

Start of study to end of study, for up to four years
Recommended Dose
Start of study to end of study, up to four years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Year 4
Duration of Response
Overall Response Rate
Overall Survival
Progression Free Survival

Trial Safety

Trial Design

2 Treatment Groups

Phase I
1 of 2
Phase II
1 of 2

Experimental Treatment

51 Total Participants · 2 Treatment Groups

Primary Treatment: Omacetaxine · No Placebo Group · Phase 1 & 2

Phase IExperimental Group · 2 Interventions: Omacetaxine, Azacitidine · Intervention Types: Drug, Drug
Phase IIExperimental Group · 2 Interventions: Omacetaxine, Azacitidine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omacetaxine mepesuccinate
FDA approved
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study start date to study end date, or death, whichever comes first, up to 4 years.

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,607 Previous Clinical Trials
1,932,292 Total Patients Enrolled
Daniel Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
118 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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Frequently Asked Questions

For what purpose is Azacitidine typically prescribed?

"Azacitidine can be used as an effective treatment for induction chemotherapy, refractory anemias, and leukemia, myelocytic, acute." - Anonymous Online Contributor

Unverified Answer

What are the investigators hoping to learn from this research?

"The main objective of this trial is to monitor the Overall Response Rate over a period of four years. Secondary objectives include Progression Free Survival, Duration of Response, and Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])." - Anonymous Online Contributor

Unverified Answer

Can new patients still sign up for this research project?

"Yes, as of today this trial is still recruiting patients. The original posting was on September 17th, 2018 with the latest update being October 19th, 2021." - Anonymous Online Contributor

Unverified Answer

Do we have any prior data to draw upon regarding Azacitidine?

"There are currently 183 ongoing clinical trials investigating the use of azacitidine, 33 of which are in Phase 3. While several trials for azacitidine are located in Houston, Texas, there are a total of 5735 locations worldwide where clinical trials for azacitidine are taking place." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.