Myelodysplastic SyndromesPhase 1/2NCT06091267
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
A Phase 1/2 study testing IV Decitabine, Decitabine and cedazuridine and only Decitabine and cedazuridine in people with Myelodysplastic Syndromes, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- IV Decitabine, Decitabine and cedazuridine and only Decitabine and cedazuridine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.
- Previous diagnosis of malignant tumor.
- History of immune deficiency.
- Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
- Conditions
- Myelodysplastic Syndromes
- Being tested
- IV Decitabine, Decitabine and cedazuridine, only Decitabine and cedazuridine
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV DecitabineDrug
The subjects will receive decitabine 20 mg/m^2 IV daily × 5 days in 28-day cycles.
Decitabine and cedazuridineDrug
subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.
only Decitabine and cedazuridineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ASTX727 and IV Decitabine | Experimental | Cycle1：ASTX727 tablets, oral, 1 tablet/day for 5 days；Cycle2：IV Decitabine, 20 mg/m^2, is administered for 1 hour at a time for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days Receives: Drug: IV Decitabine; Drug: Decitabine and cedazuridine; Drug: only Decitabine and cedazuridine |
| IV Decitabine and ASTX727 | Active comparator | Cycle1：IV Decitabine, 20 mg/m^2, is administered for 1 hour at a time for 5 days； Cycle2：ASTX727 tablets, oral, 1 tablet/day for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days Receives: Drug: IV Decitabine; Drug: Decitabine and cedazuridine; Drug: only Decitabine and cedazuridine |
| ASTX727 | Experimental | ASTX727 tablets, oral, 1 tablet/day for 5 days； Receives: Drug: only Decitabine and cedazuridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Assess efficacy [Complete Response Rate (CR)] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS);
Measured: An analysis is planned when the last enrolled patient have completed Follow-up 12 months.
5day_AUC0-τ
Assess pharmacokinetic (PK) parameters (Total 5-day AUC exposures of decitabine) after treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 days;
Measured: 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 (16)
Objective Response Rate
Objective Response Rate (ORR): The proportion of subjects who achieve CR and partial response (PR) based on IWG 2006 criteria;
Measured: through study completion, an average of 1 year.
Clinical Response Rate
Clinical Response Rate: The proportion of subjects who achieve CR, PR, marrow complete response (mCR), and hematologic improvement (HI) based on IWG 2006 criteria.
Measured: through study completion, an average of 1 year.
Rate of transfusion independence
Rate of transfusion independence: The proportion of subjects who had no blood transfusion of 2 or more units of PRBCs for 56 days or more after treatment;
Measured: through study completion, an average of 1 year.
disease progression
Time to progression to acute myeloid leukemia (AML);
Measured: through study completion, an average of 1 year.
Overall survival
Overall survival (OS).
Measured: through study completion, an average of 1 year.
Safety assessment
Safety as assessed by adverse events (AEs), concomitant medications, physical examination, clinical laboratory tests (hematology , serum chemistry and urinalysis), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and electrocardiogram (ECG).
Measured: through study completion, an average of 1 year.
peak concentration (Cmax)
Decitabine PK parameters: peak concentration (Cmax).
Measured: through study completion, an average of 1 year.
time to peak concentration (Tmax)
Decitabine PK parameters: time to peak concentration (Tmax).
Measured: through study completion, an average of 1 year.
area under the plasma concentration-time curve over a dosing interval (AUC0-τ).
Decitabine PK parameters: area under the plasma concentration-time curve over a dosing interval (AUC0-τ).
Measured: through study completion, an average of 1 year.
accumulation ratio based on AUC0-τ (Rac_AUC0-τ).
Decitabine PK parameters: accumulation ratio based on AUC0-τ (Rac_AUC0-τ).
Measured: through study completion, an average of 1 year.
accumulation ratio based on Cmax (Rac_Cmax).
Decitabine PK parameters: accumulation ratio based on Cmax (Rac_Cmax).
Measured: through study completion, an average of 1 year.
Cmax
PK parameters of E7727 and E7727-epimer: Cmax.
Measured: through study completion, an average of 1 year.
Tmax
PK parameters of E7727 and E7727-epimer: Tmax.
Measured: through study completion, an average of 1 year.
AUC0-τ
PK parameters of E7727 and E7727-epimer: area under the plasma concentration-time curve over a dosing interval .
Measured: through study completion, an average of 1 year.
Rac_AUC0-τ
PK parameters of E7727 and E7727-epimer: accumulation ratio based on AUC0-τ.
Measured: through study completion, an average of 1 year.
Rac_Cmax
PK parameters of E7727 and E7727-epimer: accumulation ratio based on Cmax.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start16 Oct 2023
- Primary completion22 May 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091267
- Sponsor's protocol ID
- 393-403-00072
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT06091267
- Acronym / sponsor ID
- 393-403-00072
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASTX727 and IV Decitabine | Experimental | Drug: IV Decitabine, Drug: Decitabine and cedazuridine, Drug: only Decitabine and cedazuridineCycle1：ASTX727 tablets, oral, 1 tablet/day for 5 days；Cycle2：IV Decitabine, 20 mg/m^2, is administered for 1 hour at a time for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days |
| IV Decitabine and ASTX727 | Active comparator | Drug: IV Decitabine, Drug: Decitabine and cedazuridine, Drug: only Decitabine and cedazuridineCycle1：IV Decitabine, 20 mg/m^2, is administered for 1 hour at a time for 5 days； Cycle2：ASTX727 tablets, oral, 1 tablet/day for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days |
| ASTX727 | Experimental | Drug: only Decitabine and cedazuridineASTX727 tablets, oral, 1 tablet/day for 5 days； |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.
- Previous diagnosis of malignant tumor.
- History of immune deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV DecitabineThe subjects will receive decitabine 20 mg/m^2 IV daily × 5 days in 28-day cycles. | Drug | ASTX727 and IV Decitabine, IV Decitabine and ASTX727 |
| Decitabine and cedazuridinesubjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles. | Drug | ASTX727 and IV Decitabine, IV Decitabine and ASTX727 |
| only Decitabine and cedazuridinesubjects 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. | Drug | ASTX727, ASTX727 and IV Decitabine, IV Decitabine and ASTX727 |
Primary outcome
Complete Response Rate
Time frame: An analysis is planned when the last enrolled patient have completed Follow-up 12 months.
Assess efficacy [Complete Response Rate (CR)] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS);
5day_AUC0-τ
Time frame: An analysis is planned when the last enrolled patient have completed the treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 day.
Assess pharmacokinetic (PK) parameters (Total 5-day AUC exposures of decitabine) after treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 days;
16 secondary outcomes
Objective Response Rate
Time frame: through study completion, an average of 1 year.
Clinical Response Rate
Time frame: through study completion, an average of 1 year.
Rate of transfusion independence
Time frame: through study completion, an average of 1 year.
disease progression
Time frame: through study completion, an average of 1 year.
Overall survival
Time frame: through study completion, an average of 1 year.
Safety assessment
Time frame: through study completion, an average of 1 year.
peak concentration (Cmax)
Time frame: through study completion, an average of 1 year.
time to peak concentration (Tmax)
Time frame: through study completion, an average of 1 year.
area under the plasma concentration-time curve over a dosing interval (AUC0-τ).
Time frame: through study completion, an average of 1 year.
accumulation ratio based on AUC0-τ (Rac_AUC0-τ).
Time frame: through study completion, an average of 1 year.
accumulation ratio based on Cmax (Rac_Cmax).
Time frame: through study completion, an average of 1 year.
Cmax
Time frame: through study completion, an average of 1 year.
Tmax
Time frame: through study completion, an average of 1 year.
AUC0-τ
Time frame: through study completion, an average of 1 year.
Rac_AUC0-τ
Time frame: through study completion, an average of 1 year.
Rac_Cmax
Time frame: through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IV Decitabine, Decitabine and cedazuridine and only Decitabine and cedazuridine in people with Myelodysplastic Syndromes, run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: An analysis is planned when the last enrolled patient have completed Follow-up 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.