This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

DS-3201b in Participants With Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732275
Recruitment Status : Active, not recruiting
First Posted : April 8, 2016
Last Update Posted : April 8, 2024
Sponsor:
Collaborator:
Daiichi Sankyo
Information provided by (Responsible Party):
Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 three 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
  3. Drug-Drug Interaction (DDI) Cohort (US Only) is to evaluate the effect of DS-3201b on the pharmacokinetics (PK) midazolam and digoxin when co-administered to patients with NHL

Condition or disease Intervention/treatment Phase
Lymphoma, Malignant Non-hodgkin Lymphoma Drug: DS-3201b Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: DS-3201b Drug: DS-3201b


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 ]
  5. 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 ]
  6. Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough) [ Time Frame: Day 15 of the first 28-day cycle ]
  7. Dose Escalation Period: Average plasma concentration (Cavg) [ Time Frame: Day 15 of the first 28-day cycle ]
  8. DDI cohort only: Maximum concentration (Cmax) of DS-3201, midazolam, digoxin [ Time Frame: within the first 28-day cycle ]
    Categories: Day -4, Cycle 1 Day 1, Cycle 1 Day 15

  9. DDI cohort only: Time of maximum concentration (Tmax) of DS-3201, midazolam, digoxin [ Time Frame: within the first 28-day cycle ]
    Categories: Day -4, Day 0 (for alternate schedule), Cycle 1 Day 1, Cycle 1 Day 15

  10. DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin [ Time Frame: within the first 28-day cycle ]
    Categories: Day -4, Day 0 (for alternate schedule), Cycle 1 Day 1, Cycle 1 Day 15

  11. DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin [ Time Frame: within the first 28-day cycle ]
    Cycle 1 Day 1, Cycle 1 Day 15

  12. 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


Secondary Outcome Measures :
  1. 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, CTCL


  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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)

  7. 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)

  8. Number of participants with CTCL who achieved response per 2011 CTCL criteria [ Time Frame: through the end of the study (within approximately 5 years) ]
    Categories: CR,PR,SD,PD,Relapse


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 (not applicable for the DDI cohort)
  • 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. For DDI cohort, CTCL is not exclusionary.
  • 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

DDI Cohort Only:

  • Has received following medications within 14 days prior to study drug administration
  • Any CYP3A inhibitors/inducers including weak CYP3A inhibitors/inducers, and P-gp inhibitors, midazolam as well as digoxin
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02732275


Locations
Show Show 20 study locations
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo
Investigators
Layout table for investigator information
Study Director: Global Clinical Leader, MD Daiichi Sankyo
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02732275    
Other Study ID Numbers: DS3201-A-J101
163173 ( Registry Identifier: JAPIC CTI )
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
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 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
Statistical Analysis Plan (SAP)
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/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. ):
Adult T-cell leukemia-lymphoma (ATL)
Peripheral T-cell lymphoma (PTCL)
Cutaneous T-cell lymphoma (CTCL)
B-cell lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases