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Decitabine

Decitabine and cedazuridine drug combination

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Cycle1：ASTX727 tablets, oral, 1 tablet/day for 5 days；Cycle2：IV Decitabine, 20 mg/m\^2, is administered for 1 hour at a time for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days

Cycle1：IV Decitabine, 20 mg/m\^2, is administered for 1 hour at a time for 5 days； Cycle2：ASTX727 tablets, oral, 1 tablet/day for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days

ASTX727 tablets, oral, 1 tablet/day for 5 days；

The subjects will receive decitabine 20 mg/m\^2 IV daily × 5 days in 28-day cycles.

IV Decitabine

subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.

Decitabine and cedazuridine

subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles, until disease progression, unacceptable toxicity, or the subject/investigator decides that the subject should discontinue treatment or withdraw from the trial.

only Decitabine and cedazuridine

Lei Cui

Jie Jin

Hongyan Tong

This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes

PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes

An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes

Assess efficacy \[Complete Response Rate (CR)\] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS);

Assess pharmacokinetic (PK) parameters (Total 5-day AUC exposures of decitabine) after treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 days;

Objective Response Rate (ORR): The proportion of subjects who achieve CR and partial response (PR) based on IWG 2006 criteria;

Clinical Response Rate: The proportion of subjects who achieve CR, PR, marrow complete response (mCR), and hematologic improvement (HI) based on IWG 2006 criteria.

Rate of transfusion independence: The proportion of subjects who had no blood transfusion of 2 or more units of PRBCs for 56 days or more after treatment;

Time to progression to acute myeloid leukemia (AML);

Safety as assessed by adverse events (AEs), concomitant medications, physical examination, clinical laboratory tests (hematology , serum chemistry and urinalysis), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and electrocardiogram (ECG).

Decitabine PK parameters: peak concentration (Cmax).

Decitabine PK parameters: time to peak concentration (Tmax).

Decitabine PK parameters: area under the plasma concentration-time curve over a dosing interval (AUC0-τ).

Decitabine PK parameters: accumulation ratio based on AUC0-τ (Rac_AUC0-τ).

Decitabine PK parameters: accumulation ratio based on Cmax (Rac_Cmax).

PK parameters of E7727 and E7727-epimer: Cmax.

PK parameters of E7727 and E7727-epimer: Tmax.

PK parameters of E7727 and E7727-epimer: area under the plasma concentration-time curve over a dosing interval .

PK parameters of E7727 and E7727-epimer: accumulation ratio based on AUC0-τ.

PK parameters of E7727 and E7727-epimer: accumulation ratio based on Cmax.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes	NCT06091267	Myelodysplastic...	IV Decitabine Decitabine and ... only Decitabine...	18 Years -	Otsuka Beijing Research Institute
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes	NCT06091267	Myelodysplastic...	IV Decitabine Decitabine and ... only Decitabine...	18 Years -	Otsuka Beijing Research Institute
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes	NCT06091267	Myelodysplastic...	IV Decitabine Decitabine and ... only Decitabine...	18 Years -	Otsuka Beijing Research Institute

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