Clinical trial NCT06091267: PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects with Myelodysplastic Syndromes
Official title: An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Complete Response Rate
timeFrame: An analysis is planned when the last enrolled patient have completed Follow-up 12 months.
measure: 5day_AUC0-τ
timeFrame: An analysis is planned when the last enrolled patient have completed the treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 day.
Secondary outcomes:
measure: Objective Response Rate
timeFrame: through study completion, an average of 1 year.
measure: Clinical Response Rate
timeFrame: through study completion, an average of 1 year.
measure: Rate of transfusion independence
timeFrame: through study completion, an average of 1 year.
measure: disease progression
timeFrame: through study completion, an average of 1 year.
measure: Overall survival
timeFrame: through study completion, an average of 1 year.
measure: Safety assessment
timeFrame: through study completion, an average of 1 year.
measure: peak concentration (Cmax)
timeFrame: through study completion, an average of 1 year.
measure: time to peak concentration (Tmax)
timeFrame: through study completion, an average of 1 year.
measure: area under the plasma concentration-time curve over a dosing interval (AUC0-τ).
timeFrame: through study completion, an average of 1 year.
measure: accumulation ratio based on AUC0-τ (Rac_AUC0-τ).
timeFrame: through study completion, an average of 1 year.
measure: accumulation ratio based on Cmax (Rac_Cmax).
timeFrame: through study completion, an average of 1 year.
measure: Cmax
timeFrame: through study completion, an average of 1 year.
measure: Tmax
timeFrame: through study completion, an average of 1 year.
measure: AUC0-τ
timeFrame: through study completion, an average of 1 year.
measure: Rac_AUC0-τ
timeFrame: through study completion, an average of 1 year.
measure: Rac_Cmax
timeFrame: through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: