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Clinical Trial Details

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Brief Title Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral CDAi in Patients With MDS
Official Title A Phase1-2 Pharmacokinetic Guided Dose-Escalation and Dose-Confirmation Study of ASTX727, a Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 With Oral Decitabine in Subjects With Myelodysplastic Syndromes (MDS)
Principal Investigator Odenike, Olatoyosi
Brief Summary This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well as determine the dose for the study's second stage. In the second stage the selected dose will be confirmed and evaluated for clinical activity, including response rate.
Gender Both
Ages 18 Years
Enrollment 85
Accepts Healthy Volunteers No
Lead Sponsor Astex PharmaceuticalsIndustry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1/Phase 2
Study Type Interventional
Contact Name Raoul Tibes, MD, PhD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Myelodysplastic Syndrome
Detail for Health Professional (on clinicaltrials.gov)
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