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DS-3201b in Participants With Lymphomas

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ClinicalTrials.gov Identifier: NCT02732275
Recruitment Status : Recruiting
First Posted : April 8, 2016
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE April 8, 2016
Last Update Posted Date August 30, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: within 28 days after the initial dose of the study drug ]
    Number of DLT-evaluable participants with protocol-defined DLTs
  • Dose Escalation Period: Maximum concentration (Cmax) of DS-3201 [ Time Frame: within the first 28-day cycle ]
    Categories: Cycle 1 Day 1, Cycle 1 Day 15
  • Dose Escalation Period: Time of maximum concentration (Tmax) of DS-3201 [ Time Frame: within the first 28-day cycle ]
    Categories: Cycle 1 Day 1, Cycle 1 Day 15
  • Dose Escalation Period: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201 [ Time Frame: Day 1 of the first 28-day cycle ]
  • Dose Escalation Period: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201 [ Time Frame: Day 1 of the first 28-day cycle ]
  • Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough) [ Time Frame: Day 15 of the first 28-day cycle ]
  • Dose Escalation Period: Average plasma concentration (Cavg) [ Time Frame: Day 15 of the first 28-day cycle ]
  • Number of participants with malignant lymphoma who achieved each level of therapeutic response per international consensus standards [ Time Frame: through the end of the study (within approximately 5 years) ]
    Categories: Complete remission (CR), Partial remission (PR), Stable disease (SD), Relapsed disease or progressive disease (RD/PD)
  • Number of participants with ATL who achieved each level of therapeutic response per international consensus standards [ Time Frame: through the end of the study (within approximately 5 years) ]
    Categories: CR, Uncertified complete remission (CRu), PR, SD, RD/PD, Unassessable (UA)
  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: through the end of the study (within approximately 5 years) ]
    TEAEs are systematically collected from lab values, physical exams, and other investigations
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • number of dose limiting toxicities [ Time Frame: day 28 ]
    incidence of toxicities graded according to common terminology criteria for adverse events CTCAE
  • maximum concentration Cmax [ Time Frame: day 28 ]
  • time of maximum concentration Tmax [ Time Frame: day 28 ]
  • area under the plasma concentration time curve up to the last quantifiable time AUClast [ Time Frame: day 28 ]
  • area under the plasma concentration time curve during dosing interval AUCtau [ Time Frame: day 28 ]
Change History Complete list of historical versions of study NCT02732275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Best overall response, based on international consensus criteria [ Time Frame: from the start of study treatment to the end of follow-up visit (within 5 years) ]
    Best overall response is defined as the percentage of participants who achieved each category as the best response, considering all overall responses assessed at all time points after the start of study treatment. Categories: CR, CRu, PR, SD, RD/PD, UA Categories: Malignant lymphoma, ATL
  • Objective response rate (ORR) [ Time Frame: within 5 years ]
    ORR is defined as the percentage of participants who were assessed for best overall response, who achieved CR, UCR, or PR
  • Disease control rate (DCR) [ Time Frame: within 5 years ]
    DCR is defined as the percentage of participants who were assessed for best overall response, who achieved a best response of CR, UCR, PR, or SD
  • Duration of response (DOR) [ Time Frame: within 5 years ]
    DOR is defined as the time from the date at which criteria are first met for CR or PR (including CRu for ATL) until the first date that progressive disease is objectively documented.
  • Progression-free survival (PFS) [ Time Frame: witihn 5 years ]
    PFS is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of disease progression or death due to any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • response rate based on international consensus criteria [ Time Frame: week8, 16, 24, 32, 40 ]
    Response rate based on international consensus criteria according to Revised Response Criteria for Malignant Lymphoma or Definition, Prognostic Factors, Treatment, and Response Criteria of Adult T-cell Lymphoma-leukemia (ATLL)
  • disease control rate based on international consensus criteria [ Time Frame: week8, 16, 24, 32, 40 ]
    Disease control rate based on international consensus criteria according to Revised Response Criteria for Malignant Lymphoma or Definition, Prognostic Factors, Treatment, and Response Criteria of ATLL
  • the change of tri-methylated histone H3 lysine 27 (H3K27Me3) status by Immunohistochemistry [ Time Frame: day 28 ]
    the change of H3K27Me3 status by Immunohistochemistry to assess the DS-3201b effect on H3K27Me3 in blood/ skin biopsy as the exploratory pharmacodynamic biomarkers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DS-3201b in Participants With Lymphomas
Official Title  ICMJE A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas
Brief Summary

DS-3201b is an experimental drug. It is not approved for regular use. It can only be used in clinical research.

Adults with non-Hodgkin lymphoma (NHL) might be able to join this study if their disease:

  • has come back after remission
  • is not responding to current treatment

This study has two parts:

  1. Dose Escalation is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate.
  2. Dose Expansion is to:

    • find out how effective DS-3201b is for rare types of NHL
    • collect additional safety data
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Malignant
  • Non-hodgkin Lymphoma
Intervention  ICMJE Drug: DS-3201b
Study Arms  ICMJE Experimental: DS-3201b
Intervention: Drug: DS-3201b
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2016)
36
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has hematocytological or pathological diagnosis of non- Hodgkin's lymphoma (NHL)
  • Has relapsed from or is refractory to standard treatment or no standard treatment is available
  • Is the age of majority in their country (18 in the US and 20 in Japan) at the time of informed consent
  • Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Has at least one evaluable lesion site
  • Has preserved organ function based on baseline laboratory data at screening tests
  • If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a protocol-defined form of contraception or avoid intercourse, during and upon completion of the study, and for at least 3 months after the last dose of study drug
  • Tumor biopsy collections:

    1. willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline
    2. [US only] willing to provide fresh on-treatment tumor biopsy if deemed acceptable risk by the investigator

      [Japan only] fresh on-treatment tumor biopsy should be performed if deemed acceptable risk by the investigator

    3. willing to provide optional fresh end-of-treatment biopsy

For ATL subjects:

  • Has a positive test result for human T-lymphotropic virus type I antibody
  • Has ATL subtype classified as acute, lymphomatous, or chronic with poor prognostic factor
  • Has diagnosis of relapse (including relapse after partial remission [PR]) or treatment-resistant ATL at the time of informed consent after prior treatment with at least 1 anti-cancer medication regimen

Exclusion Criteria:

  • Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia
  • Has a history or presence of central nervous system (CNS) involvement
  • Has a medical history, complication or other malignancy considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study
  • Has received drugs or other treatments not allowed by the protocol
  • History of treatment with other enhancer of zeste (EZH) inhibitors
  • Has had allogeneic hematopoietic stem cell transplantation (HTCP) within 90 days before scheduled dosing on Cycle 1 Day 1
  • Is pregnant or breastfeeding
  • Is otherwise deemed ineligible to participate by the investigator or sub-investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02732275
Other Study ID Numbers  ICMJE DS3201-A-J101
163173 ( Registry Identifier: JAPIC CTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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 https://vivli.org/. 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://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all 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, the European Union and/or Japan 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://vivli.org/ourmember/daiichi-sankyo/
Responsible Party Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
Study Sponsor  ICMJE Daiichi Sankyo Co., Ltd.
Collaborators  ICMJE Daiichi Sankyo, Inc.
Investigators  ICMJE
Study Director: Global Clinical Leader, MD Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP