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A Phase 1/2 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)

Not Enrolling

Trial ID:NCT02103478

View complete trial on ClinicalTrials.gov

Protocol #:14-195

DiseasesLymphoid Leukemia, Myeloid and Monocytic Leukemia, Leukemia, other

Phase:I/II

Principal Investigator:Steensma, David, Peter

Site Investigator(s):Amrein, Philip, C.
Attar, Eyal, C.

Research Nurse(s):Toomey-Mathews, Ellen,

Trial Description:
Dose levels for the study's second stage will be based on safety and pharmacokinetics.

Eligibilty Requirements:
IPSS low, intermediate -1, intermediate-2, or high risk MDS (including CMML) in Dose Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS in Dose Confirmation-Open Label

ECOG 0 to 2

No major surgery within 2 weeks of starting study treatment

No cytotoxic chemotherapy within 2 weeks of starting study treatment

Able to swallow pills

Previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (Dose Confirmation stage only)

Treatment with investigational therapy within 2 weeks of study treatment

Uncontrolled medical disease(s) or active, uncontrolled infection

Diagnosed with AML

Active uncontrolled gastric or duodenal ulcer

Known history of HIV or hepatitis C or B