IRB #

STUDY00018352

Title

A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) versus IV Decitabine in Subjects with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Principal Investigator

Elie Traer

Study Purpose

The purpose of this study is to examine blood levels of the study drug during treatment and to see how subjects respond to the study drug.

This study is being done to answer the following question:

How would the body respond to ASTX727 (an oral formulation of Cedazuridine and Decitabine) versus the usual decitabine? Would ASTX727 help improve a patient’s body exposure to decitabine?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML).

Medical Condition(s)

Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with MDS or CMML
-Your disease has not responded to previous treatment or it has not been previously treated.

Age Range

18 - n/a

Healthy Volunteers Needed

No

Duration of Participation

The study is estimated to last about 18 months.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Astex Pharmaceuticals, Inc.

Recruitment End

01/01/2028

Compensation Provided

No


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