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Last Updated: September 24, 2021

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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
NCT03306264 ↗ Phase 3 Study of ASTX727 vs IV Decitabine in MDS and CMML Not yet recruiting Astex Pharmaceuticals Phase 3 2017-12-01 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. In Phase 1 Stage A, subjects will be randomized in a 1:1:1 ratio into 3 cohorts of 6 subjects each in a 10-day schedule in 28-day cycles; when safety is established in Stage A, 24 evaluable subjects will be randomized in a 1:1:1:1 ratio in Phase 1 Stage B into 4 cohorts of 6 subjects each in a 14-day schedule in 28-day cycles. In Phase 2, 40 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules selected from Phase 1.
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. In Phase 1 Stage A, subjects will be randomized in a 1:1:1 ratio into 3 cohorts of 6 subjects each in a 10-day schedule in 28-day cycles; when safety is established in Stage A, 24 evaluable subjects will be randomized in a 1:1:1:1 ratio in Phase 1 Stage B into 4 cohorts of 6 subjects each in a 14-day schedule in 28-day cycles. In Phase 2, 40 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules selected from Phase 1.
NCT03813186 ↗ Effect of Food on Blood Levels of ASTX727 Recruiting Astex Pharmaceuticals Phase 1 2018-11-08 This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants with myelodysplastic syndromes (MDS), including refractory anemia with excess blasts in transformation or chronic myelomonocytic leukemia (CMML). This study will also assess the safety of ASTX727.
NCT03875287 ↗ Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors Not yet recruiting Astex Pharmaceuticals Phase 1 2019-03-01 This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 30 patients total).
NCT03875287 ↗ Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors Not yet recruiting Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Phase 1 2019-03-01 This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 30 patients total).
>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 7
Myelodysplastic Syndromes 6
Recurrent Acute Myeloid Leukemia 4
Refractory Acute Myeloid Leukemia 4
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Condition MeSH

Condition MeSH for Cedazuridine; Decitabine
Intervention Trials
Myelodysplastic Syndromes 10
Leukemia 10
Preleukemia 8
Syndrome 7
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Clinical Trial Locations for Cedazuridine; Decitabine

Trials by Country

Trials by Country for Cedazuridine; Decitabine
Location Trials
United States 15
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Trials by US State

Trials by US State for Cedazuridine; Decitabine
Location Trials
Texas 7
New York 2
Massachusetts 2
Tennessee 1
Maryland 1
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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 1
Phase 2 6
Phase 1/Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Cedazuridine; Decitabine
Clinical Trial Phase Trials
Not yet recruiting 17
Recruiting 4
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Clinical Trial Sponsors for Cedazuridine; Decitabine

Sponsor Name

Sponsor Name for Cedazuridine; Decitabine
Sponsor Trials
M.D. Anderson Cancer Center 7
Astex Pharmaceuticals 6
Astex Pharmaceuticals, Inc. 5
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Sponsor Type

Sponsor Type for Cedazuridine; Decitabine
Sponsor Trials
Industry 17
Other 14
NIH 3
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