Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML

  • STATUS
    Not Recruiting
  • participants needed
    200
  • sponsor
    Astex Pharmaceuticals, Inc.
Updated on 12 August 2022
anemia
chronic myelomonocytic leukemia
secondary aml
decitabine
direct bilirubin
leukemia
induction chemotherapy
secondary acute myeloid leukemia
blast cells
conjugated bilirubin
myelomonocytic leukemia
ringed sideroblasts
astx727
secondary myelodysplastic syndrome

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 Daily5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily5 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.

Description

This Phase 3 study will establish PK equivalence of ASTX727 to IV decitabine in approximately 118 evaluable subjects. Eligible subjects will receive both study treatments: oral investigational drug ASTX727, and IV decitabine, as follows: subjects will be randomly assigned 1:1 to receive ASTX727 or IV decitabine in Cycle 1 and then cross over to the other therapy in Cycle 2.

In the ASTX727 cycle, subjects will receive the ASTX727 tablet Daily5. Serial PK measurements (blood draws) will be done on Days 1, 2, and 5, along with pre-dose PK assessments on Days 1-5 and an assessment at 3 hours post dose on Day 3. Subjects will be required to fast from food for 4 hours on days when receiving ASTX727: at least 2 hours before and 2 hours after dosing.

In the IV decitabine cycle, subjects will receive a 1-hour infusion of IV decitabine 20 mg/m^2 Daily5. Serial PK measurements will be done on Days 1 and 5, along with pre-dose and 1-hour post-infusion assessments on Day 3.

In Cycles 3, subjects will receive the ASTX727 tablet Daily5 in 28-day cycles. (No PK assessments will be done from Cycle 3 onward.)

Details
Condition Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
Treatment ASTX727, Dacogen
Clinical Study IdentifierNCT03306264
SponsorAstex Pharmaceuticals, Inc.
Last Modified on12 August 2022

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