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

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ClinicalTrials.gov Identifier: NCT03671564
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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
Acute Myeloid Leukemia Drug: Milademetan Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 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
Drug: Milademetan
Milademetan, an MDM2 inhibitor, is provided in capsules for oral administration
Other Name: DS-3032b




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: at approximately 28 days after start of treatment ]
  2. Number of Participants with treatment emergent adverse events (TEAEs) [ Time Frame: through completion of follow-up, within approximately 1 year ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) ]
  2. Time to reach Cmax (Tmax) [ Time Frame: 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) [ Time Frame: Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days) ]
  4. 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
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

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): NCT03671564


Contacts
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Contact: Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111 (M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Locations
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Japan
Japanese Red Cross Narita Hospital Recruiting
Chiba, Japan, 286-0041
Contact: See Central Contact         
Kyusyu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: See Central Contact         
Gifu Municipal Hospital Recruiting
Gifu, Japan, 500-8513
Contact: See Central Contact         
Chugoku Central Hospital Recruiting
Hiroshima, Japan, 720-0001
Contact: See Central Contact         
National Hospital Organization Kumamoto Medical Center Recruiting
Kumamoto, Japan, 860-0008
Contact: See Central Contact         
Tenri Hospital Recruiting
Nara, Japan, 632-8552
Contact: See Central Contact         
NTT Medical Center Tokyo Recruiting
Tokyo, Japan, 141-8625
Contact: See Central Contact         
National Hospital Organization Disaster Medical Center Recruiting
Tokyo, Japan, 190-0014
Contact: See Central Contact         
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT03671564     History of Changes
Other Study ID Numbers: DS3032-A-J104
184054 ( Registry Identifier: JAPIC CTI )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 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/

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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, Inc. ( Daiichi Sankyo Co., Ltd. ):
Oncology
MDM2
Escalation with overdose control (EWOC)

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms