Clinical Trials /

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

NCT03906695

Description:

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

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 393-102-00002
  • NCT ID: NCT03906695

Conditions

  • Lower-risk Myelodysplastic

Interventions

DrugSynonymsArms
ASTX727 LDStage A

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Stage AExperimental10-Day Schedule 3 cohorts each in a 10-day schedule in 28-day cycles of ASTX727 LD
  • ASTX727 LD
Stage BExperimental14-Day Schedule 4 cohorts each in a 14-day schedule in 28-day cycles of ASTX727 LD
  • ASTX727 LD

Eligibility Criteria

        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 and sexually active women of
             child-bearing potential must agree to use 2 effective contraceptive measures or remain
             abstinent during the trial and for 3 months after final administration of IMP.

          -  Subjects who have provided written informed consent using the form approved by the
             institutional review board

        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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicity
Time Frame:28days
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:pharmacokinetics parameter
Measure: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
Safety Issue:
Description:pharmacokinetics parameter

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Otsuka Pharmaceutical Co., Ltd.

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