NCT02732275

Brief Summary

DS-3201b is an experimental drug that is being investigated in clinical research. Adults with non-Hodgkin lymphoma (NHL) may be able to join this study if their disease has come back after remission or is not responding to current treatment This study has three parts. The Dose Escalation part is designed is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate. The Dose Expansion phase will determine how effective DS-3201b is for rare types of NH and collect additional safety data. Last, the Drug-Drug Interaction (DDI) Cohort (US Only) will evaluate the effect of DS-3201b on the pharmacokinetics (PK) of midazolam and digoxin when co-administered to patients with NHL

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Mar 2016

Longer than P75 for phase_1

Geographic Reach
2 countries

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2016Dec 2027

Study Start

First participant enrolled

March 31, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

6.8 years

First QC Date

April 4, 2016

Last Update Submit

April 23, 2026

Conditions

Lymphoma, MalignantNon-hodgkin Lymphoma

Keywords

Adult T-cell leukemia-lymphoma (ATL)Peripheral T-cell lymphoma (PTCL)Cutaneous T-cell lymphoma (CTCL)B-cell lymphoma

Outcome Measures

Primary Outcomes (12)

  • Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs)

    Number of DLT-evaluable participants with protocol-defined DLTs

    within 28 days after the initial dose of the study drug

  • Dose Escalation Period: Maximum concentration (Cmax) of DS-3201

    Categories: Cycle 1 Day 1, Cycle 1 Day 15

    within the first 28-day cycle

  • Dose Escalation Period: Time of maximum concentration (Tmax) of DS-3201

    Categories: Cycle 1 Day 1, Cycle 1 Day 15

    within the first 28-day cycle

  • Dose Escalation Period: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201

    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

    Day 1 of the first 28-day cycle

  • Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough)

    Day 15 of the first 28-day cycle

  • Dose Escalation Period: Average plasma concentration (Cavg)

    Day 15 of the first 28-day cycle

  • DDI cohort only: Maximum concentration (Cmax) of DS-3201, midazolam, digoxin

    Categories: Day -4, Cycle 1 Day 1, Cycle 1 Day 15

    within the first 28-day cycle

  • DDI cohort only: Time of maximum concentration (Tmax) of DS-3201, midazolam, digoxin

    Categories: Day -4, Day 0 (for alternate schedule), Cycle 1 Day 1, Cycle 1 Day 15

    within the first 28-day cycle

  • DDI cohort only: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201,midazolam,digoxin

    Categories: Day -4, Day 0 (for alternate schedule), Cycle 1 Day 1, Cycle 1 Day 15

    within the first 28-day cycle

  • DDI cohort only: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201, midazolam, digoxin

    Cycle 1 Day 1, Cycle 1 Day 15

    within the first 28-day cycle

  • Number of participants with treatment-emergent adverse events (TEAEs)

    TEAEs are systematically collected from lab values, physical exams, and other investigations

    through the end of the study (within approximately 5 years)

Secondary Outcomes (6)

  • Best overall response, based on international consensus criteria

    from the start of study treatment to the end of follow-up visit (within 5 years)

  • Objective response rate (ORR)

    within 5 years

  • Disease control rate (DCR)

    within 5 years

  • Duration of response (DOR)

    within 5 years

  • Progression-free survival (PFS)

    witihn 5 years

  • +1 more secondary outcomes

Study Arms (2)

Dose Escalation - DS-3201b

EXPERIMENTAL

Dose escalation is to identify the recommended phase 2 dose of DS-3201b guided by the modified continuous reassessment method using a Bayesian logistic regression model following escalation.

Drug: DS-3201b

Dose Expansion - DS-3201b

EXPERIMENTAL

Part 2 is a dose expansion to examine the safety and efficacy of DS-3201b.

Drug: DS-3201b

Interventions

DS-3201bDRUG

DS-3201 to be administered orally once daily in each 28-day cycle.

Dose Escalation - DS-3201b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline
  • \[US only\] 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

City of Hope National Medical center

Duarte, California, 91010, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Ohio State University Wexner Medical Center and James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

National Cancer Center Hospital East

Kahiwa-shi, Chiba, 277-8577, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Imamura General Hospital

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Kumamoto University Hosipital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, Okinawa, 903-0215, Japan

Location

The Institute of Medical Science, The University of Tokyo

Minato-ku, Tokyo, 108-8639, Japan

Location

National Cancer Center Hospital

Chūōku, Toyko, 104-0045, Japan

Location

Related Publications (1)

  • Maruyama D, Jacobsen E, Porcu P, Allen P, Ishitsuka K, Kusumoto S, Narita T, Tobinai K, Foss F, Tsukasaki K, Feldman T, Imaizumi Y, Izutsu K, Morishima S, Yamauchi N, Yuda J, Brammer JE, Kawamata T, Ruan J, Nosaka K, Utsunomiya A, Wang J, Zain J, Kakurai Y, Yamauchi H, Hizukuri Y, Biserna N, Tachibana M, Inoue A, Horwitz SM. Valemetostat monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma: a first-in-human, multicentre, open-label, single-arm, phase 1 study. Lancet Oncol. 2024 Dec;25(12):1589-1601. doi: 10.1016/S1470-2045(24)00502-3. Epub 2024 Oct 29.

    PMID: 39486432DERIVED

MeSH Terms

Conditions

LymphomaLymphoma, Non-HodgkinLeukemia-Lymphoma, Adult T-CellLymphoma, T-Cell, PeripheralLymphoma, T-Cell, CutaneousLymphoma, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, T-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-Cell

Study Officials

  • Global Clinical Leader, MD

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

March 31, 2016

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

JP(10)US(10)