Conditions: Leukemia, Myeloid, Acute Leukemia, Lymphocytic, Acute
Keywords: AML ALL Enhancer of zeste homolog (EZH) inhibitor DS-3201b
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 28
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants who received 100 mg DS-3201b administered orally to participants with AML or ALL. arm 2: Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL. arm 3: Participants who received 250 mg DS-3201b administered orally to participants with AML or ALL. arm 4: Participants who received 500 mg DS-3201b administered orally to participants with AML or ALL. arm 5: Participants who received 700 mg DS-3201b administered orally to participants with AML or ALL.

Interventions: intervention 1: DS-3201b
Intervention descriptions: intervention 1: DS-3201b is supplied as 25 and 100 mg capsules packaged in high-density polyethylene (HDPE) bottles.

Protocol document:
Prot_SAP_000.pdf: 
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Protocol DS3201-A-U102 
Version 6.0, 29 Jun 2020 
Proprietary and Confidential 
Page 2 
INVESTIGATOR AGREEMENT 
A Phase I Study of DS-3201b in Subjects with Acute Myelogenous Leukemia 
(AML) or Acute Lymphocytic Leukemia (ALL) 
Sponsor Approval: 
This clinical study protocol has been reviewed and approved by the Daiichi Sankyo Inc. 
representative listed below. 
 
 
 
Print Name 
Signature
 
Senior Director, Global Oncology R&D
29-June-2020
 
Title 
 
Date (DD MMM YYYY) 
 
 
Investigator’s Signature: 
I have fully discussed the objectives of this study and the contents of this protocol with the 
Sponsor’s representative. 
I understand that information contained in or pertaining to this protocol is confidential and 
should not be disclosed, other than to those directly involved in the execution or the ethical 
review of the study, without written authorization from the Sponsor.  It is, however, permissible 
to provide information to a subject in order to obtain consent. 
I agree to conduct this study according to this protocol and to comply with its requirements, 
subject to ethical and safety considerations and guidelines, and to conduct the study in 
accordance with the Declaration of Helsinki, International Council for Harmonisation guidelines 
on Good Clinical Practice (ICH E6), and applicable regional regulatory requirements. 
I agree to make available to Sponsor personnel, their representatives and relevant regulatory 
authorities, my subjects’ study records in order to verify the data that I have entered into the case 
report forms.  I am aware of my responsibilities as a Principal Investigator as provided by the 
Sponsor. 
I understand that the Sponsor may decide to suspend or prematurely terminate the study at any 
time for whatever reason; such a decision will be communicated to me in writing.  Conversely, 
should I decide to withdraw from execution of the study, I will communicate my intention 
immediately in writing to the Sponsor. 
 
 
 
 
Print Name 
 
Signature 
 
 
 
Title 
 
Date (DD MMM YYYY) 
 
PPD
PPD


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