Actively Recruiting
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
Led by Taiho Pharmaceutical Co., Ltd. · Updated on 2025-12-03
40
Participants Needed
10
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to identify the doses of the oral azacitidine formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2
CONDITIONS
Official Title
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 20 years or older
- Diagnosis of Myelodysplastic Syndrome (MDS) including RA, RARS, RAEB, RAEB-T, or CMML by FAB classification
- Low or intermediate-1 risk patients by IPSS only if unlikely to respond to other treatment or currently treated with azacitidine injection
- ECOG performance status score of 0 or 1, or 2 due to primary disease
- Adequate hepatic function: total bilirubin ≤ 2.0 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
- Adequate renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance/glomerular filtration rate ≥ 50 mL/min
- Respiratory function with oxygen saturation (SpO2) ≥ 90%
- Expected survival of at least 3 months
- Provided written informed consent
You will not qualify if you...
- Unlikely to respond to azacitidine
- Received chemotherapy, hormone therapy, antibody therapy, radiotherapy, or other anticancer treatments within 3 weeks before first study drug dose
- Used any other investigational medicinal product or privately imported medicine within 4 weeks before first study drug dose
- Heart disease classified as New York Heart Association Class 3 or 4
- Uncontrolled systemic disease or active infection
- Uncontrolled gastric or duodenal ulcer
- Prior or current interstitial lung disease
- History of surgical gastrectomy
- Life-threatening conditions, multiple organ failure, or factors affecting safety or drug metabolism
- Other malignancies except certain treated or stable cancers
- Positive for HIV antibody, HBV-DNA, or HCV antibody
- Grade 2 or higher adverse events from prior treatment (except alopecia)
- Recent highly invasive surgery within 4 weeks before first study drug dose
- Previous or planned hematopoietic stem cell transplantation
- History of hypersensitivity to study drug or its components
- High risk for protocol noncompliance due to mental disorders or substance abuse
- Pregnant or nursing females, or positive pregnancy test at screening
- Sexually active males or females of childbearing potential not agreeing to use two birth control methods or abstinence during and after trial
- Investigator judgment deeming patient otherwise ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Nippon Medical School Hospital
Bunkyō City, Japan
Actively Recruiting
2
Fukushima Medical University Hospital
Fukushima, Japan
Actively Recruiting
3
Saitama Medical University Hospital
Iruma, Japan
Actively Recruiting
4
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Actively Recruiting
5
Nagasaki University Hospital
Nagasaki, Japan
Actively Recruiting
6
Osaka City General Hospital
Osaka, Japan
Actively Recruiting
7
Kindai University Hospital
Sakai, Japan
Actively Recruiting
8
NTT Medical Center Tokyo
Shinagawa-Ku, Japan
Actively Recruiting
9
Tokyo Medical University Hospital
Shinjuku-Ku, Japan
Actively Recruiting
10
Yamagata University Hospital
Yamagata, Japan
Actively Recruiting
Research Team
D
Drug Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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