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Trial Title:
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
NCT ID:
NCT06091267
Condition:
Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Decitabine
Decitabine and cedazuridine drug combination
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IV Decitabine
Description:
The subjects will receive decitabine 20 mg/m^2 IV daily × 5 days in 28-day cycles.
Arm group label:
ASTX727 and IV Decitabine
Arm group label:
IV Decitabine and ASTX727
Intervention type:
Drug
Intervention name:
Decitabine and cedazuridine
Description:
subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in
28-day cycles.
Arm group label:
ASTX727 and IV Decitabine
Arm group label:
IV Decitabine and ASTX727
Intervention type:
Drug
Intervention name:
only Decitabine and cedazuridine
Description:
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.
Arm group label:
ASTX727
Arm group label:
ASTX727 and IV Decitabine
Arm group label:
IV Decitabine and ASTX727
Summary:
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral
ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital,Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin
Phone:
+86-0571-87236898
Email:
jiej0503@163.com
Contact backup:
Last name:
Hongyan Tong
Phone:
+86-0571-87235589
Email:
hongyantong@aliyun.com
Start date:
October 16, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Otsuka Beijing Research Institute
Agency class:
Industry
Source:
Otsuka Beijing Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06091267
