Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06091267

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Agree to participate in this trial and voluntarily sign the informed consent form.
  • Men or women ≥ 18 years at the time of signing the informed consent form.
  • Subjects with MDS previously treated or untreated with de novo or secondary MDS.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.

Exclusion criteria

  • Prior treatment with more than 1 cycle of azacitidine or decitabine.
  • Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment.
  • Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.
  • Previous diagnosis of malignant tumor.
  • History of immune deficiency.
  • Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.

Treatment and study plan

IV Decitabine

Drug

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

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.

Primary outcomes

  1. Complete Response Rate

    Time frame: An analysis is planned when the last enrolled patient have completed Follow-up 12 months.

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

  2. 5day_AUC0-τ

    Time frame: An analysis is planned when the last enrolled patient have completed the treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 day.

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

Secondary outcomes

  1. Objective Response Rate

    Time frame: through study completion, an average of 1 year.

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

  2. Clinical Response Rate

    Time frame: through study completion, an average of 1 year.

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

  3. Rate of transfusion independence

    Time frame: through study completion, an average of 1 year.

    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;

  4. disease progression

    Time frame: through study completion, an average of 1 year.

    Time to progression to acute myeloid leukemia (AML);

  5. Overall survival

    Time frame: through study completion, an average of 1 year.

    Overall survival (OS).

  6. Safety assessment

    Time frame: through study completion, an average of 1 year.

    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).

  7. peak concentration (Cmax)

    Time frame: through study completion, an average of 1 year.

    Decitabine PK parameters: peak concentration (Cmax).

  8. time to peak concentration (Tmax)

    Time frame: through study completion, an average of 1 year.

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

  9. area under the plasma concentration-time curve over a dosing interval (AUC0-τ).

    Time frame: through study completion, an average of 1 year.

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

  10. accumulation ratio based on AUC0-τ (Rac_AUC0-τ).

    Time frame: through study completion, an average of 1 year.

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

  11. accumulation ratio based on Cmax (Rac_Cmax).

    Time frame: through study completion, an average of 1 year.

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

  12. Cmax

    Time frame: through study completion, an average of 1 year.

    PK parameters of E7727 and E7727-epimer: Cmax.

  13. Tmax

    Time frame: through study completion, an average of 1 year.

    PK parameters of E7727 and E7727-epimer: Tmax.

  14. AUC0-τ

    Time frame: through study completion, an average of 1 year.

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

  15. Rac_AUC0-τ

    Time frame: through study completion, an average of 1 year.

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

  16. Rac_Cmax

    Time frame: through study completion, an average of 1 year.

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

Sponsors and collaborators

Lead sponsor

Otsuka Beijing Research Institute

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 19, 2023
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.