Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT ID: NCT03671564
Last Updated: 2023-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2018-08-23
2019-09-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT05924750
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
NCT03106428
A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00923182
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan
NCT01464411
A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
NCT00462761
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Milademetan (90 mg/Day)
Participants who received milademetan 90 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle.
Milademetan
Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.
Milademetan (120 mg/Day)
Participants who received milademetan 120 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle.
Milademetan
Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.
Milademetan (160 mg/Day)
Participants who received milademetan 160 mg daily (QD) Day 1 - 14 followed by 14-day rest in a 28-day cycle.
Milademetan
Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Milademetan
Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* AML for which no standard treatment is available
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Study Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Japanese Red Cross Narita Hospital
Chiba, , Japan
Kyusyu University Hospital
Fukuoka, , Japan
Gifu Municipal Hospital
Gifu, , Japan
Chugoku Central Hospital
Hiroshima, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Tenri Hospital
Nara, , Japan
NTT Medical Center Tokyo
Tokyo, , Japan
National Hospital Organization Disaster Medical Center
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
184054
Identifier Type: REGISTRY
Identifier Source: secondary_id
DS3032-A-J104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.