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Last Updated: December 9, 2024

CLINICAL TRIALS PROFILE FOR CEDAZURIDINE; DECITABINE


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All Clinical Trials for Cedazuridine; Decitabine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02103478 ↗ 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.
NCT02103478 ↗ 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.
NCT03306264 ↗ 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.
NCT03306264 ↗ 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.
NCT03502668 ↗ Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS Recruiting Chiltern International Inc. Phase 1/Phase 2 2018-07-27 Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with IPSS risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cedazuridine; Decitabine

Condition Name

Condition Name for Cedazuridine; Decitabine
Intervention Trials
Acute Myeloid Leukemia 14
Myelodysplastic Syndromes 12
Recurrent Acute Myeloid Leukemia 7
Chronic Myelomonocytic Leukemia 6
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Condition MeSH

Condition MeSH for Cedazuridine; Decitabine
Intervention Trials
Leukemia 20
Myelodysplastic Syndromes 19
Leukemia, Myeloid 16
Preleukemia 16
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Clinical Trial Locations for Cedazuridine; Decitabine

Trials by Country

Trials by Country for Cedazuridine; Decitabine
Location Trials
United States 97
Canada 7
Germany 4
Spain 3
Australia 3
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Trials by US State

Trials by US State for Cedazuridine; Decitabine
Location Trials
Texas 15
New York 8
Maryland 7
California 6
Tennessee 6
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Clinical Trial Progress for Cedazuridine; Decitabine

Clinical Trial Phase

Clinical Trial Phase for Cedazuridine; Decitabine
Clinical Trial Phase Trials
Phase 3 2
Phase 2 12
Phase 1/Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Cedazuridine; Decitabine
Clinical Trial Phase Trials
Not yet recruiting 20
Recruiting 16
Completed 2
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Clinical Trial Sponsors for Cedazuridine; Decitabine

Sponsor Name

Sponsor Name for Cedazuridine; Decitabine
Sponsor Trials
Astex Pharmaceuticals, Inc. 17
National Cancer Institute (NCI) 11
M.D. Anderson Cancer Center 10
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Sponsor Type

Sponsor Type for Cedazuridine; Decitabine
Sponsor Trials
Industry 35
Other 28
NIH 11
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