Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2016-03-31
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation - DS-3201b
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.
DS-3201b
DS-3201 to be administered orally once daily in each 28-day cycle.
Dose Expansion - DS-3201b
Part 2 is a dose expansion to examine the safety and efficacy of DS-3201b.
DS-3201b
DS-3201 to be administered orally once daily in each 28-day cycle at the recommended dose for expansion.
Interventions
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DS-3201b
DS-3201 to be administered orally once daily in each 28-day cycle.
DS-3201b
DS-3201 to be administered orally once daily in each 28-day cycle at the recommended dose for expansion.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader, MD
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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City of Hope National Medical center
Duarte, California, United States
Yale University
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medicine
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center and James Cancer Hospital
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kahiwa-shi, Chiba, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Imamura General Hospital
Kagoshima, Kagoshima-ken, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Kumamoto University Hosipital
Kumamoto, Kumamoto, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
University of the Ryukyus Hospital
Nakagami-gun, Okinawa, Japan
The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, Japan
National Cancer Center Hospital
Chūōku, Toyko, Japan
Countries
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References
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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.
Other Identifiers
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163173
Identifier Type: REGISTRY
Identifier Source: secondary_id
DS3201-A-J101
Identifier Type: -
Identifier Source: org_study_id
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