A Phase 1/2 interventional study of IV Decitabine and Decitabine and cedazuridine in Myelodysplastic Syndromes, sponsored by Otsuka Beijing Research Institute. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Otsuka Beijing Research Institute (part of Otsuka Holdings Co., Ltd.) · Phase 1/2, Interventional, and Treatment
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Among 75 studies testing decitabine in Myelodysplastic Syndromes — 9 open to participants now, 16 under way, 1 of them phase 3. Decitabine · Myelodysplastic Syndromes.
Among the 75 studies testing decitabine in Myelodysplastic Syndromes, this one is the 24th largest by planned enrollment of the 74 interventional ones that give a count, is one of 4 that started in 2023, is one of 10 in phase 1/2, reaches primary completion later than 6 of the 15 other live ones, and was the 72nd registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →9 of the 75 studies testing decitabine in Myelodysplastic Syndromes are open now, in 3 countries. Recruiting first, the newest first:
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+ · Healthy volunteers
West Virginia University · Sites in United States
Ages 18+
Beijing 302 Hospital · Sites in China
Ages 18–70
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 60+
Clinical Hub for Interventional Research (CHOIR) · Sites in Australia
Ages 18+
By country, each count listing its studies:
Decitabine: first FDA approval 2006 (DACOGEN), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 28 · Phase 2 49 · Phase 3 6 · Phase 4 3
First in 1995; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 43 across the 74 interventional studies. Of the 48 that completed or were terminated, 29 (60%) have results posted.
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17 of 75 have an industry lead sponsor. The 10 most frequent:
This study is registered under Otsuka Beijing Research Institute, one of the names counted as Otsuka Holdings Co., Ltd.. Under that name alone:
Otsuka Beijing Research Institute is the lead sponsor of 36 studies on the registry; none are open to participants now.
17 studies in Myelodysplastic Syndromes by Otsuka Holdings Co., Ltd.: 5 open now, 7 under way, 2 of them phase 3. Of 10 finished, 4 (40%) have results posted.
Among the 17 studies in Myelodysplastic Syndromes by Otsuka Holdings Co., Ltd., this one is the 8th largest by planned enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2023, is one of 4 in phase 1/2, and was the 17th registered.
Otsuka Holdings Co., Ltd.’s Myelodysplastic Syndromes studies by the year they started, since 2001.
2 of the studies testing decitabine in Myelodysplastic Syndromes that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06923488West Virginia UniversityLeflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes | 2027-10 |
| NCT04282187University of WashingtonDecitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms | 2027-11-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 75 studies testing decitabine in Myelodysplastic Syndromes, from their registry updates:
Among Otsuka Holdings Co., Ltd.’s 17 in Myelodysplastic Syndromes:
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This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: IV Decitabine · Drug: Decitabine and cedazuridine · Drug: only Decitabine and cedazuridine
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
Drug: IV Decitabine · Drug: Decitabine and cedazuridine · Drug: only Decitabine and cedazuridine
ASTX727 tablets, oral, 1 tablet/day for 5 days；
Drug: only Decitabine and cedazuridine
The subjects will receive decitabine 20 mg/m\^2 IV daily × 5 days in 28-day cycles.
subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.
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.
Complete Response Rate
Assess efficacy \[Complete Response Rate (CR)\] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS);
Time frame: 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;
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.
Objective Response Rate
Objective Response Rate (ORR): The proportion of subjects who achieve CR and partial response (PR) based on IWG 2006 criteria;
Time frame: 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.
Time frame: 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;
Time frame: through study completion, an average of 1 year.
disease progression
Time to progression to acute myeloid leukemia (AML);
Time frame: through study completion, an average of 1 year.
Overall survival
Overall survival (OS).
Time frame: 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).
Time frame: through study completion, an average of 1 year.
peak concentration (Cmax)
Decitabine PK parameters: peak concentration (Cmax).
Time frame: through study completion, an average of 1 year.
time to peak concentration (Tmax)
Decitabine PK parameters: 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).
Decitabine PK parameters: 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).
Decitabine PK parameters: 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).
Decitabine PK parameters: accumulation ratio based on Cmax (Rac\_Cmax).
Time frame: through study completion, an average of 1 year.
Cmax
PK parameters of E7727 and E7727-epimer: Cmax.
Time frame: through study completion, an average of 1 year.
Tmax
PK parameters of E7727 and E7727-epimer: Tmax.
Time frame: 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 .
Time frame: through study completion, an average of 1 year.
Rac_AUC0-τ
PK parameters of E7727 and E7727-epimer: accumulation ratio based on AUC0-τ.
Time frame: through study completion, an average of 1 year.
Rac_Cmax
PK parameters of E7727 and E7727-epimer: accumulation ratio based on Cmax.
Time frame: through study completion, an average of 1 year.
Ran from Oct 2023 to primary completion in May 2026, 31 months.
Of 41 industry-sponsored phase 1/2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 78 months of starting (the median), counting those still running; a quarter within 56 and three quarters within 91. This study's 31 months is below that.
Counting every sponsor, half of 109 studies reached it within 78 months; a quarter within 49 and three quarters within 110.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Decitabine
Otsuka Beijing Research Institute →