Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral CDAi in Patients With MDS

  • Interventional
  • Not Recruiting
  • NCT02103478
Eligibility Details Visit Clinicaltrials.gov

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)

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.

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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

        Exclusion Criteria:

         - 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

At a Glance

National Government IDNCT02103478

IRB#IRB14-0702

Lead SponsorAstex Pharmaceuticals

Lead PhysicianOlatoyosi Odenike

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting