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Trial record 1 of 2 for:    DS-3201
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DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

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ClinicalTrials.gov Identifier: NCT03110354
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.


Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Leukemia, Lymphocytic, Acute Drug: DS-3201b Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of DS-3201b in Subjects With Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 27, 2019
Estimated Study Completion Date : March 27, 2019


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Part 1: Number of participants with dose-limiting toxicities [ Time Frame: within 28 days ]
    Part 1 is the 28-day dose escalation part

  2. Part 2: Number of participants with dose-limiting toxicities [ Time Frame: within 2 years ]
    Part 2 is the dose expansion part

  3. Parts 1 and 2: Number of participants who experienced an adverse event during the trial [ Time Frame: within 2 years ]
    Adverse events are collected for the entire duration of study participation


Secondary Outcome Measures :
  1. Maximum (peak) observed concentration (Cmax) [ Time Frame: within 8 days ]
    Cmax is the highest concentration of the drug in circulating plasma (blood) as observed on days 1-2 and 8 of each part's single 28-day pharmacokinetics (PK) cycle.

  2. Time to maximum observed concentration (Tmax) [ Time Frame: within 8 days ]
    Tmax is the time it takes for Cmax to be reached as observed on days 1-2 and 8 of each part's single 28-day PK cycle.

  3. Area under the curve up to the last quantifiable time (AUClast) [ Time Frame: within 8 days ]
    Area under the plasma concentration-time curve up to the last measurable concentration as observed on days 1-2 and 8 of each part's single 28-day PK cycle.

  4. Trough plasma concentration (Ctrough) [ Time Frame: within 2 years ]
    Trough concentration is the lowest concentration reached by a drug before the next dose is administered as observed Pre-dose on Days 2, 8, 15, 22 in the single 28-day cycle 1, day 1 of cycle 2 and End of Treatment

  5. Part 2: Number of participants with response to treatment [ Time Frame: within 2 years ]
    Response to treatment is defined per the revised International Working Group (IWG) response criteria for AML (Cheson 2003) or standard response criteria for ALL (NCCN 2016 ALL response criteria)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110354


Locations
United States, Alabama
University of Alabama Terminated
Birmingham, Alabama, United States, 35294
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Principal Investigator    734-936-9814    dbixby@umich.edu   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Principal Investigator    212-639-2194    rampalr@mskcc.org   
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Principal Investigator    615-936-8422    Michael.savona@vanderbilt.edu   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Naval Daver, MD    713-794-4392    NDaver@mdanderson.org   
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03110354     History of Changes
Other Study ID Numbers: DS3201-A-U102
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daiichi Sankyo, Inc.:
AML
ALL
Enhancer of zeste homolog (EZH) inhibitor
DS-3201b

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases