Acute Myeloid Leukemia Clinical Trial

DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

Summary

This research study tests an investigational drug called DS-3201b. An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It is not known if DS-3201b will work or not.

This study consists of two parts. The first part (Part 1) is a dose escalation that will enroll subjects with AML or ALL that did not respond or no longer respond to previous standard therapy. The purpose of Part 1 of this research study is to determine the highest dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be enrolled at that dose into Part 2 of the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has AML or ALL and failed any prior induction therapy regimen or have relapsed after prior therapy
Has Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Has adequate renal and hepatic function
Had at least 14 days for prior treatment to clear the body before initiation of DS-3201b administration (except for hydroxyurea that needs only 2 days for clearance)
Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.
Agrees to use an adequate method of contraception during the study and until 3 months after the last treatment.
Is willing to provide bone marrow biopsies and comply with protocol-defined evaluations
Has a life expectancy of at least 3 months

Exclusion Criteria:

Has presence of central nervous system (CNS) involvement of leukemia or a history of CNS leukemia
Has a second concurrent active primary malignancy such as solid tumor or lymphoma under active treatment
Has refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, graft versus- host disease (GVHD) significantly affecting gut motility or absorption, or any other condition that would preclude adequate absorption of DS- 3201b in the opinion of the treating physician and/or principal investigator (PI)
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or tested positive for active hepatitis B or C infection
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
Has unresolved toxicities from previous anticancer therapy
Has received hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of DS-3201b
Has received concomitant treatment with a strong inhibitor or inducer of cytochrome P450 (CYP)3A4/5 within 7 days of first receipt of DS-3201b
Has consumed herbs/fruits that may have an influence on pharmacokinetics (PK) of DS-3201b from 3 days (14 days for St. John's wort) prior to the start of the study and throughout the entire study
Had major surgery within 4 weeks before study drug treatment
Has prolonged corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) based on triplicate electrocardiograms (ECGs)
Is pregnant or breastfeeding
Has substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results
Has received prior treatment with enhancer of zeste homolog (EZH) inhibitor

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

28

Study ID:

NCT03110354

Recruitment Status:

Terminated

Sponsor:

Daiichi Sankyo, Inc.

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There are 6 Locations for this study

See Locations Near You

Massachusetts General Hospital
Boston Massachusetts, 02115, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University
Durham North Carolina, 27710, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

28

Study ID:

NCT03110354

Recruitment Status:

Terminated

Sponsor:


Daiichi Sankyo, Inc.

How clear is this clinincal trial information?

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