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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:March 28, 2017
End Date:March 27, 2019

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A Phase 1 Study of DS-3201b in Subjects With Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

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.


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
We found this trial at
6
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-2194
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-1124
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-936-9814
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Birmingham, Alabama 35294
Phone: 205-996-5590
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Houston, Texas 77030
Phone: 713-794-4392
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Phone: 615-936-8422
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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