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Clinical Trial Details

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Brief Title Study of ASTX727 vs IV Decitabine in MDS and CMML
Official 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) [ASTX727-02]
Principal Investigator Odenike, Olatoyosi
Brief Summary Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.
Gender All
Ages 18 Years
Enrollment 132
Accepts Healthy Volunteers No
Lead Sponsor Astex PharmaceuticalsIndustry
Collaborator
Study Design
Study Phase Phase 3
Study Type Interventional
Contact Name Casey O'Connell, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Myelodysplastic Syndromes
Detail for Health Professional (on clinicaltrials.gov)
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