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 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
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
Drug | Synonyms | Arms |
---|
DS-3201b | | DS-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 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
Trial Arms
Name | Type | Description | Interventions |
---|
DS-3201b | Experimental | | |
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 (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
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, CTCL |
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. |
Measure: | 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) |
Safety Issue: | |
Description: | Categories: Complete remission (CR), Partial remission (PR), Stable disease (SD), Relapsed disease or progressive disease (RD/PD) |
Measure: | 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) |
Safety Issue: | |
Description: | Categories: CR, Uncertified complete remission (CRu), PR, SD, RD/PD, Unassessable (UA) |
Measure: | Number of participants with CTCL who achieved response per 2011 CTCL criteria |
Time Frame: | through the end of the study (within approximately 5 years) |
Safety Issue: | |
Description: | Categories: CR,PR,SD,PD,Relapse |
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)
- Cutaneous T-cell lymphoma (CTCL)
- B-cell lymphoma
Last Updated
July 19, 2021