Back to resultsStudy of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Milademetan
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Oncology, MDM2, Escalation with overdose control (EWOC)
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
Sites / Locations
- Japanese Red Cross Narita Hospital
- Kyusyu University Hospital
- Gifu Municipal Hospital
- Chugoku Central Hospital
- National Hospital Organization Kumamoto Medical Center
- Tenri Hospital
- NTT Medical Center Tokyo
- National Hospital Organization Disaster Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation - Milademetan
Arm Description
All participants enrolled for dose escalation receive a single oral dose of 90 mg milademetan, followed by escalated doses, based on mCRM with EWOC
Outcomes
Primary Outcome Measures
Number of Participants with Dose Limiting Toxicities (DLTs)
Number of Participants with treatment emergent adverse events (TEAEs)
Secondary Outcome Measures
Maximum plasma concentration (Cmax)
Time to reach Cmax (Tmax)
Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)
Trough plasma concentration (Ctrough)
Full Information
NCT ID
NCT03671564
First Posted
September 4, 2018
Last Updated
October 28, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03671564
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
September 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
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
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Oncology, MDM2, Escalation with overdose control (EWOC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation - Milademetan
Arm Type
Experimental
Arm Description
All participants enrolled for dose escalation receive a single oral dose of 90 mg milademetan, followed by escalated doses, based on mCRM with EWOC
Intervention Type
Drug
Intervention Name(s)
Milademetan
Other Intervention Name(s)
DS-3032b
Intervention Description
Milademetan, an MDM2 inhibitor, is provided in capsules for oral administration
Primary Outcome Measure Information:
Title
Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame
at approximately 28 days after start of treatment
Title
Number of Participants with treatment emergent adverse events (TEAEs)
Time Frame
through completion of follow-up, within approximately 1 year
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Time Frame
Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
Title
Time to reach Cmax (Tmax)
Time Frame
Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
Title
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)
Title
Trough plasma concentration (Ctrough)
Time Frame
Cycle 1: Day 1, 2, 8, 14; Cycle 2: Day 1 (within approximately 29 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Japanese Red Cross Narita Hospital
City
Chiba
ZIP/Postal Code
286-0041
Country
Japan
Facility Name
Kyusyu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Chugoku Central Hospital
City
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Tenri Hospital
City
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Learn more about this trial
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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