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

Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03671564
Collaborator
(none)
14
Enrollment
8
Locations
1
Arm
12.5
Actual Duration (Months)
1.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 23, 2018
Actual Primary Completion Date :
Sep 6, 2019
Actual Study Completion Date :
Sep 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation - Milademetan

All participants enrolled for dose escalation receive a single oral dose of 90 mg milademetan, followed by escalated doses, based on mCRM with EWOC

Drug: Milademetan
Milademetan, an MDM2 inhibitor, is provided in capsules for oral administration
Other Names:
  • DS-3032b

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Dose Limiting Toxicities (DLTs) [at approximately 28 days after start of treatment]

    2. Number of Participants with treatment emergent adverse events (TEAEs) [through completion of follow-up, within approximately 1 year]

    Secondary Outcome Measures

    1. Maximum plasma concentration (Cmax) [Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)]

    2. Time to reach Cmax (Tmax) [Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)]

    3. Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast) [Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)]

    4. Trough plasma concentration (Ctrough) [Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Japanese Red Cross Narita Hospital Chiba Japan 286-0041
    2 Kyusyu University Hospital Fukuoka Japan 812-8582
    3 Gifu Municipal Hospital Gifu Japan 500-8513
    4 Chugoku Central Hospital Hiroshima Japan 720-0001
    5 National Hospital Organization Kumamoto Medical Center Kumamoto Japan 860-0008
    6 Tenri Hospital Nara Japan 632-8552
    7 NTT Medical Center Tokyo Tokyo Japan 141-8625
    8 National Hospital Organization Disaster Medical Center Tokyo Japan 190-0014

    Sponsors and Collaborators

    • Daiichi Sankyo Co., Ltd.

    Investigators

    • Study Director: Clinical Study Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03671564
    Other Study ID Numbers:
    • DS3032-A-J104
    • 184054
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Oct 29, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Daiichi Sankyo Co., Ltd.
    Oncology
    MDM2
    Escalation with overdose control (EWOC)
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Oct 29, 2019