Omacetaxine + Azacitidine for Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

Dan Pollyea, MD, MS | Profiles | School ...

Overseen byDaniel Pollyea, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Daniel Pollyea, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults over 18 with high grade myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia who haven't been treated before, or have tried a treatment but it didn't work. They should be relatively healthy otherwise, with good kidney and liver function, and not have other serious illnesses or active infections.

Inclusion Criteria

My condition is either high-grade MDS or chronic leukemia with more than 5% bone marrow blasts.

Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures

I can take care of myself and am up and about more than half of my waking hours.

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Exclusion Criteria

Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to: New York Heart Association heart failure > class 2, Renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia, Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Patients on antibiotics with controlled systemic symptoms will not be excluded, Subject has uncontrolled diabetes, Subject has had a recent major hemorrhage or has a bleeding diathesis associated with a high risk of bleeding, Pregnant and breastfeeding females

Subject is known to be positive for HIV. HIV testing is not required

I had cancer before, but it was either skin cancer, treated breast or cervical cancer, prostate cancer not needing treatment, or any cancer that was completely removed or treated.

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Treatment Details

Interventions

Azacitidine (DNA Methyltransferase Inhibitor)
Omacetaxine (Protein Synthesis Inhibitor)

Trial OverviewThe study tests the combination of two drugs, omacetaxine mepesuccinate and azacitidine, in treating patients with untreated high-grade MDS. It aims to see how well these drugs work together as an initial therapy or after other treatments failed.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Phase IIExperimental Treatment2 Interventions

Up to 33 patients will be enrolled to receive the maximum tolerated dose (determined in phase I) over a 28 day cycle. Azacitidine will be given at the standard dose over a 28 day cycle.

Group II: Phase IExperimental Treatment2 Interventions

Up to 18 patients will be enrolled to one of three cohorts to receive various doses of omacetaxine over a 28 day cycle. Azacitidine will be given at the standard dose over a 28 day cycle.

Azacitidine is already approved in Canada, Japan for the following indications: