Clinical Trials /

DS-3201b in Participants With Lymphomas

NCT02732275

Description:

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

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: DS-3201b in Participants With Lymphomas
  • Official Title: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas

Clinical Trial IDs

  • ORG STUDY ID: DS3201-A-J101
  • SECONDARY ID: 163173
  • NCT ID: NCT02732275

Conditions

  • Lymphoma, Malignant
  • Non-hodgkin Lymphoma

Interventions

DrugSynonymsArms
DS-3201bDS-3201b

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
DS-3201bExperimental
  • DS-3201b

Eligibility 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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs)
Time Frame:within 28 days after the initial dose of the study drug
Safety Issue:
Description:Number of DLT-evaluable participants with protocol-defined DLTs

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description: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
Measure:Objective response rate (ORR)
Time Frame:within 5 years
Safety Issue:
Description:ORR is defined as the percentage of participants who were assessed for best overall response, who achieved CR, UCR, or PR
Measure:Disease control rate (DCR)
Time Frame:within 5 years
Safety Issue:
Description: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
Measure:Duration of response (DOR)
Time Frame:within 5 years
Safety Issue:
Description: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.
Measure:Progression-free survival (PFS)
Time Frame:witihn 5 years
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Trial Keywords

  • Adult T-cell leukemia-lymphoma (ATL)
  • Peripheral T-cell lymphoma (PTCL)

Last Updated

November 1, 2019