Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Has AML or ALL and failed any prior induction therapy regimen or have relapsed after prior therapy
  2. Has Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  3. Has adequate renal and hepatic function
  4. 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)
  5. 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.
  6. Agrees to use an adequate method of contraception during the study and until 3 months after the last treatment.
  7. Is willing to provide bone marrow biopsies and comply with protocol-defined evaluations
  8. Has a life expectancy of at least 3 months

Exclusion Criteria

  1. Has presence of central nervous system (CNS) involvement of leukemia or a history of CNS leukemia
  2. Has a second concurrent active primary malignancy such as solid tumor or lymphoma under active treatment
  3. 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)
  4. 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
  5. Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
  6. Has unresolved toxicities from previous anticancer therapy
  7. Has received hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of DS-3201b
  8. 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
  9. 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
  10. Had major surgery within 4 weeks before study drug treatment
  11. 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)
  12. Is pregnant or breastfeeding
  13. 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
  14. Has received prior treatment with enhancer of zeste homolog (EZH) inhibitor

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open label

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
DS-3201b in AML or ALL
DS-3201b is administered orally to participants with AML or ALL at a starting dose of 100 mg once a day, and then possibly at higher doses depending on safety observations
  • Drug: DS-3201b
    DS-3201b is supplied as 25 and 100 mg capsules packaged in high-density polyethylene (HDPE) bottles.

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232
Contact:
Principal Investigator

More Details

Status
Recruiting
Sponsor
Daiichi Sankyo, Inc.

Study Contact

Daiichi Sankyo Contact for Clinical Trial Information
908-992-6400
CTRinfo@dsi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.