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

Last updated: March 24, 2025
Sponsor: Otsuka Beijing Research Institute
Overall Status: Active - Recruiting

Phase

1/2

Condition

White Cell Disorders

Myelodysplastic Syndromes (Mds)

Treatment

only Decitabine and cedazuridine

Decitabine and cedazuridine

IV Decitabine

Clinical Study ID

NCT06091267
393-403-00072
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Agree to participate in this trial and voluntarily sign the informed consent form.

  2. Men or women ≥ 18 years at the time of signing the informed consent form.

  3. Subjects with MDS previously treated or untreated with de novo or secondary MDS.

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.

Exclusion

Exclusion Criteria:

  1. Prior treatment with more than 1 cycle of azacitidine or decitabine.

  2. Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of firstdose of study treatment.

  3. Conditions as judged by the investigator to be inappropriate for participation inthe clinical trial.

  4. Previous diagnosis of malignant tumor.

  5. History of immune deficiency.

  6. Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% orother malignant hematological diseases.

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: only Decitabine and cedazuridine
Phase: 1/2
Study Start date:
October 16, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • The First Affiliated Hospital,Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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