- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906695
Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
A Multicenter, Open-label, Dose-escalation, Phase 1 Trial to Investigate the Tolerability and Safety of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Tokyo, Japan
- NTT Medical Center Tokyo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Subjects with a definitive diagnosis of MDS and classified as low or Intermediate-1 risk by the International Prognostic Scoring System (IPSS) risk category
- Subjects meeting at least one of the disease-related criteria for Red blood cell (RBC) transfusion, hemoglobin (Hb) ,Absolute neutrophil count,Platelet count within 8 weeks prior to initial administration of IMP
- Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Adequate hepatic and renal function
- Sexually active men with reproductive capacity (except those who have undergone bilateral orchidectomy) must agree to use 2 effective contraceptive measures or remain abstinent during the trial and for 3 months after final administration of IMP. Sexually active women of child-bearing potential must agree to use 2 effective contraceptive measures or remain abstinent during the trial and for 6 months after final administration of IMP.
- Subjects who have provided written informed consent using the form approved by the institutional review board
Key Exclusion Criteria:
- Subjects who have received cytokine therapy, immunosuppressant therapy, or chemotherapy within 4 weeks prior to initial investigational medicinal product (IMP) administration
- Subjects who have received any other IMP or privately-imported medicine within 2 weeks prior to initial IMP administration
- Subjects with deletion 5q who are to be treated with lenalidomide
- Subjects with current or previous bone marrow blast percentage of >10%
- Subjects with a diagnosis of chronic myelomonocytic leukemia
- Subjects with heart disease of New York Heart Association (NYHA) Functional Class 3 or 4
- Subjects with an uncontrolled systemic disease or active uncontrolled infection
- Subjects with diabetes mellitus requiring medical treatment
- Subjects with a life-threatening illness, medical condition or multiple organ dysfunction, or other reason, including laboratory abnormalities, which in the investigator's or subinvestigator's opinion could compromise the subject's safety, interfere with the absorption or metabolism of IMP, or compromise the integrity of the trial outcome
- Subjects with prior malignancy
- Subjects who test positive for human immunodeficiency virus antibody, hepatitis B virus DNA, or hepatitis C virus antibody
- Subjects with a history of surgical gastrectomy
- Subjects with previous organ transplantation
- Subjects with a ≥Grade 2 AE attributable to treatment of underlying disease, excluding the AEs
- Subjects who have undergone an invasive and extensive operation within 2 weeks prior to initial IMP administration
- Subjects with hypersensitivity to the IMPs or their excipients
- Subjects with known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator or subinvestigator predisposes the subject to high risk of noncompliance with the protocol
- Female subjects who are pregnant, breast-feeding, or who test positive for pregnancy at screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 10-Day Schedule
10-Day Schedule Investigational Medicinal Products (IMP) will be administered for 10 days in total per 4 weeks, i.e. a 28-day cycle. |
oral decitabine 5mg + cedazuridine
oral decitabine 10mg + cedazuridine
oral decitabine 20mg + cedazuridine
|
EXPERIMENTAL: 5-Day Schedule A
5-Day Schedule A IMP will be administered for 5 days in total per 4 weeks, i.e. a 28-day cycle. |
oral decitabine 5mg + cedazuridine
oral decitabine 10mg + cedazuridine
oral decitabine 20mg + cedazuridine
|
EXPERIMENTAL: 5-Day Schedule B
5-Day Schedule B IMP will be administered for 5 days in total per 4 weeks, i.e. a 28-day cycle. |
oral decitabine 5mg + cedazuridine
oral decitabine 10mg + cedazuridine
oral decitabine 20mg + cedazuridine
|
EXPERIMENTAL: 5-Day Schedule C
5-Day Schedule C IMP will be administered for 5 days in total per 4 weeks, i.e. a 28-day cycle. |
oral decitabine 5mg + cedazuridine
oral decitabine 10mg + cedazuridine
oral decitabine 20mg + cedazuridine
|
EXPERIMENTAL: 7-Day Schedule
7-Day Schedule IMP will be administered for 7 days in total per 4 weeks, i.e. a 28-day cycle. |
oral decitabine 5mg + cedazuridine
oral decitabine 10mg + cedazuridine
oral decitabine 20mg + cedazuridine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose Limiting Toxicity
Time Frame: 28days
|
28days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve (AUC)
Time Frame: Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing
|
pharmacokinetics parameter
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Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing
|
Maximum plasma concentration (Cmax)
Time Frame: Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing
|
pharmacokinetics parameter
|
Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 393-102-00002
- JapicCTI-194654 (OTHER: Japic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lower-risk Myelodysplastic
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Jasper Therapeutics, Inc.Recruiting
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Bristol-Myers SquibbActive, not recruitingLower-risk Myelodysplastic SyndromesJapan
-
Institute of Hematology & Blood Diseases Hospital...Beijing Health Alliance Charitable FoundationRecruitingLower Risk MDS Per IPSS-RChina
-
GWT-TUD GmbHAmsterdam UMC, location VUmc; BerGenBio ASA; Groupe Francophone des MyelodysplasiesCompletedAcute Myeloid Leukemia | High-risk Myelodysplastic Syndrome | Low-risk Myelodysplastic SyndromeGermany, Netherlands, France
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMyelodysplastic Syndrome | High Risk Myelodysplastic Syndrome | IPSS Risk Category Intermediate-1United States
-
Forma Therapeutics, Inc.RecruitingVery Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-RUnited States, France, Canada, Germany
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Assistance Publique - Hôpitaux de ParisUnknownInfection | Risk Factors | Myelodysplastic Syndrome (MDS) | IPSS High RiskFrance
-
GCP-Service International West GmbHSaint-Louis Hospital, Paris, France; University of Florence; Medical University... and other collaboratorsNot yet recruitingLow Risk Myelodysplastic SyndromesSpain, Poland, Italy, Germany, France
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Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.CompletedPreviously Treated Myelodysplastic Syndrome | Myelodysplastic Syndrome | Therapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic Syndrome | Refractory High Risk Myelodysplastic SyndromeUnited States
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Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingA. Longitudinal Cohort n=400 | B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS InterventionUnited States
Clinical Trials on ASTX727
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Astex Pharmaceuticals, Inc.CompletedMyelodysplastic Syndrome | MDSUnited States, Canada
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M.D. Anderson Cancer CenterGenentech, Inc.; Astex Pharmaceuticals, Inc.RecruitingChronic Myelomonocytic Leukemia | Myelodysplastic SyndromeUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkRecruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8United States
-
M.D. Anderson Cancer CenterRecruitingAcute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Recurrent Acute Biphenotypic Leukemia | Refractory Acute Biphenotypic LeukemiaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Astex Pharmaceuticals, Inc.RecruitingChronic Phase Chronic Myelogenous Leukemia | Philadelphia Chromosome Positive | BCR-ABL1 Positive Chronic Myelogenous Leukemia | BCR-ABL1 PositiveUnited States
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M.D. Anderson Cancer CenterRecruitingAcute Myeloid Leukemia | Myelodysplastic Syndrome | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
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Astex Pharmaceuticals, Inc.Active, not recruitingMyelodysplastic SyndromesSpain, United States, Belgium, Canada, Germany, Italy
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Vanderbilt-Ingram Cancer CenterAstex Pharmaceuticals, Inc.; Forma Therapeutics, Inc.WithdrawnAcute Myeloid Leukemia | Myelodysplastic Syndrome | Recurrent Acute Myeloid Leukemia | Recurrent Myelodysplastic Syndrome | Refractory Acute Myeloid Leukemia | Refractory Myelodysplastic Syndrome
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Astex Pharmaceuticals, Inc.CompletedAcute Myeloid Leukemia | Myelodysplastic Syndromes | Chronic Myelomonocytic LeukemiaUnited States