Comparing oral and IV treatments for myelodysplastic syndromes in Chinese patients

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

This study is testing whether an oral medication called ASTX727 works better than an IV treatment called Decitabine for Chinese patients with myelodysplastic syndromes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Otsuka Beijing Research Institute (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06091267 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics and efficacy of oral ASTX727 compared to IV Decitabine in Chinese patients diagnosed with myelodysplastic syndromes (MDS). It is an open-label, crossover study that includes both Phase 1 and Phase 2 assessments. Participants will receive different treatment regimens to determine the effectiveness and safety of the oral formulation. The study aims to bridge the gap in treatment options for MDS in this specific population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of myelodysplastic syndromes, either previously treated or untreated.

Not a fit: Patients with acute myeloid leukemia or those who have had extensive prior treatments with azacitidine or decitabine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective oral treatment option for patients with myelodysplastic syndromes.

How similar studies have performed: While there have been studies on MDS treatments, this specific approach of comparing oral and IV formulations in this population is relatively novel.

Eligibility criteria

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 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 first dose of study treatment.
3. Conditions as judged by the investigator to be inappropriate for participation in the 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% or other malignant hematological diseases.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital,Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Lei Cui

Conditions Myelodysplastic Syndromes