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Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03906695
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
To investigate the tolerability and safety of ASTX727 in Japanese subjects with lower-risk MDS.

Condition or disease Intervention/treatment Phase
Lower-risk Myelodysplastic Drug: ASTX727 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Dose-escalation, Phase 1 Trial to Investigate the Tolerability and Safety of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.

Drug: ASTX727
oral decitabine 5mg + 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.

Drug: ASTX727
oral decitabine 5mg + 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.

Drug: ASTX727
oral decitabine 10mg + 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.

Drug: ASTX727
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.

Drug: ASTX727
oral decitabine 10mg + cedazuridine




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 28days ]

Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Subjects with a definitive diagnosis of MDS and classified as low or Intermediate-1 risk by the International Prognostic Scoring System (IPSS) risk category
  2. 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
  3. Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  4. Adequate hepatic and renal function
  5. 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.
  6. Subjects who have provided written informed consent using the form approved by the institutional review board

Key Exclusion Criteria:

  1. Subjects who have received cytokine therapy, immunosuppressant therapy, or chemotherapy within 4 weeks prior to initial investigational medicinal product (IMP) administration
  2. Subjects who have received any other IMP or privately-imported medicine within 2 weeks prior to initial IMP administration
  3. Subjects with deletion 5q who are to be treated with lenalidomide
  4. Subjects with current or previous bone marrow blast percentage of >10%
  5. Subjects with a diagnosis of chronic myelomonocytic leukemia
  6. Subjects with heart disease of New York Heart Association (NYHA) Functional Class 3 or 4
  7. Subjects with an uncontrolled systemic disease or active uncontrolled infection
  8. Subjects with diabetes mellitus requiring medical treatment
  9. 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
  10. Subjects with prior malignancy
  11. Subjects who test positive for human immunodeficiency virus antibody, hepatitis B virus DNA, or hepatitis C virus antibody
  12. Subjects with a history of surgical gastrectomy
  13. Subjects with previous organ transplantation
  14. Subjects with a ≥Grade 2 AE attributable to treatment of underlying disease, excluding the AEs
  15. Subjects who have undergone an invasive and extensive operation within 2 weeks prior to initial IMP administration
  16. Subjects with hypersensitivity to the IMPs or their excipients
  17. 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
  18. Female subjects who are pregnant, breast-feeding, or who test positive for pregnancy at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906695


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
NTT Medical Center Tokyo Recruiting
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03906695    
Other Study ID Numbers: 393-102-00002
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms