NCT06091267Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 22 Sept 2023
- Start date
- 16 Oct 2023
- Primary completion date
- 22 May 2026
- Lead sponsor
- Otsuka Beijing Research Institute
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT06091267
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 72
- From 16 Oct 2023 to the primary completion date, 22 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Previous diagnosis of malignant tumor.
Other illness
- Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.
- History of immune deficiency.
Lab values
- Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.