Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
Completed
Astex Pharmaceuticals
Phase 1/Phase 2
2014-10-28
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of
ASTX727, as well as determined the dose for later stages.
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
Completed
Astex Pharmaceuticals, Inc.
Phase 1/Phase 2
2014-10-28
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of
ASTX727, as well as determined the dose for later stages.
Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML
Recruiting
Astex Pharmaceuticals
Phase 3
2018-02-15
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.
Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML
Recruiting
Astex Pharmaceuticals, Inc.
Phase 3
2018-02-15
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.
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