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Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT03671564

Description:

This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified continuous reassessment method (mCRM).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
  • Official Title: Phase 1, Open-label, Dose Escalation Study of Milademetan, an Oral MDM2 Inhibitor, to Assess Safety, Tolerability and Pharmacokinetics in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: DS3032-A-J104
  • NCT ID: NCT03671564

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
MilademetanDS-3032bDose Escalation - Milademetan

Purpose

This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified continuous reassessment method (mCRM).

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation - MilademetanExperimentalAll participants enrolled for dose escalation receive a single oral dose of 90 mg milademetan, followed by escalated doses, based on mCRM with EWOC
  • Milademetan

Eligibility Criteria

        Inclusion Criteria:

          -  Relapsed or refractory AML

          -  AML for which no standard treatment is available

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

        Exclusion Criteria:

          -  Acute Promyelocytic Leukemia

          -  Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)

          -  Presence of central nervous system involvement of leukemia or a history of primary
             central nervous system leukemia
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:at approximately 28 days after start of treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum plasma concentration (Cmax)
Time Frame:Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
Safety Issue:
Description:
Measure:Time to reach Cmax (Tmax)
Time Frame:Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
Safety Issue:
Description:
Measure:Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Time Frame:Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
Safety Issue:
Description:
Measure:Trough plasma concentration (Ctrough)
Time Frame:Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Trial Keywords

  • Oncology
  • MDM2
  • Escalation with overdose control (EWOC)

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