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This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASTX727 and IV Decitabine | Experimental | 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 |
|
| IV Decitabine and ASTX727 | Active Comparator | 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 | Experimental | ASTX727 tablets, oral, 1 tablet/day for 5 days； |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Decitabine | Drug | The subjects will receive decitabine 20 mg/m^2 IV daily × 5 days in 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Assess efficacy [Complete Response Rate (CR)] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS); | An analysis is planned when the last enrolled patient have completed Follow-up 12 months. |
| 5day_AUC0-τ | Assess pharmacokinetic (PK) parameters (Total 5-day AUC exposures of decitabine) after treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 days; | An analysis is planned when the last enrolled patient have completed the treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 day. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate (ORR): The proportion of subjects who achieve CR and partial response (PR) based on IWG 2006 criteria; | through study completion, an average of 1 year. |
| Clinical Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| C000723076 | decitabine and cedazuridine drug combination |
| C000633944 | cedazuridine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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| Decitabine and cedazuridine | Drug | subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles. |
|
| only Decitabine and cedazuridine | Drug | 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. |
|
Clinical Response Rate: The proportion of subjects who achieve CR, PR, marrow complete response (mCR), and hematologic improvement (HI) based on IWG 2006 criteria.
| through study completion, an average of 1 year. |
| Rate of transfusion independence | 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; | through study completion, an average of 1 year. |
| disease progression | Time to progression to acute myeloid leukemia (AML); | through study completion, an average of 1 year. |
| Overall survival | Overall survival (OS). | through study completion, an average of 1 year. |
| Safety assessment | 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). | through study completion, an average of 1 year. |
| peak concentration (Cmax) | Decitabine PK parameters: peak concentration (Cmax). | through study completion, an average of 1 year. |
| time to peak concentration (Tmax) | Decitabine PK parameters: time to peak concentration (Tmax). | through study completion, an average of 1 year. |
| area under the plasma concentration-time curve over a dosing interval (AUC0-τ). | Decitabine PK parameters: area under the plasma concentration-time curve over a dosing interval (AUC0-τ). | through study completion, an average of 1 year. |
| accumulation ratio based on AUC0-τ (Rac_AUC0-τ). | Decitabine PK parameters: accumulation ratio based on AUC0-τ (Rac_AUC0-τ). | through study completion, an average of 1 year. |
| accumulation ratio based on Cmax (Rac_Cmax). | Decitabine PK parameters: accumulation ratio based on Cmax (Rac_Cmax). | through study completion, an average of 1 year. |
| Cmax | PK parameters of E7727 and E7727-epimer: Cmax. | through study completion, an average of 1 year. |
| Tmax | PK parameters of E7727 and E7727-epimer: Tmax. | through study completion, an average of 1 year. |
| AUC0-τ | PK parameters of E7727 and E7727-epimer: area under the plasma concentration-time curve over a dosing interval . | through study completion, an average of 1 year. |
| Rac_AUC0-τ | PK parameters of E7727 and E7727-epimer: accumulation ratio based on AUC0-τ. | through study completion, an average of 1 year. |
| Rac_Cmax | PK parameters of E7727 and E7727-epimer: accumulation ratio based on Cmax. | through study completion, an average of 1 year. |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |