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. |
| NCT03502668 ↗ | Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS | Recruiting | Astex Pharmaceuticals | 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 | >Sponsor | >Phase | >Start Date | >Summary |
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