Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03671564 |
Recruitment Status :
Completed
First Posted : September 14, 2018
Last Update Posted : October 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia | Drug: Milademetan | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | August 23, 2018 |
Actual Primary Completion Date : | September 6, 2019 |
Actual Study Completion Date : | September 6, 2019 |

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
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Drug: Milademetan
Milademetan, an MDM2 inhibitor, is provided in capsules for oral administration
Other Name: DS-3032b |
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: at approximately 28 days after start of treatment ]
- Number of Participants with treatment emergent adverse events (TEAEs) [ Time Frame: through completion of follow-up, within approximately 1 year ]
- Maximum plasma concentration (Cmax) [ Time Frame: Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) ]
- Time to reach Cmax (Tmax) [ Time Frame: Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) ]
- 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) ]
- Trough plasma concentration (Ctrough) [ Time Frame: Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
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

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): NCT03671564
Japan | |
Japanese Red Cross Narita Hospital | |
Chiba, Japan, 286-0041 | |
Kyusyu University Hospital | |
Fukuoka, Japan, 812-8582 | |
Gifu Municipal Hospital | |
Gifu, Japan, 500-8513 | |
Chugoku Central Hospital | |
Hiroshima, Japan, 720-0001 | |
National Hospital Organization Kumamoto Medical Center | |
Kumamoto, Japan, 860-0008 | |
Tenri Hospital | |
Nara, Japan, 632-8552 | |
NTT Medical Center Tokyo | |
Tokyo, Japan, 141-8625 | |
National Hospital Organization Disaster Medical Center | |
Tokyo, Japan, 190-0014 |
Study Director: | Clinical Study Leader | Daiichi Sankyo, Inc. |
Responsible Party: | Daiichi Sankyo Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03671564 |
Other Study ID Numbers: |
DS3032-A-J104 184054 ( Registry Identifier: JAPIC CTI ) |
First Posted: | September 14, 2018 Key Record Dates |
Last Update Posted: | October 29, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. |
Access Criteria: | Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
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 |
Oncology MDM2 Escalation with overdose control (EWOC) |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |