DS-3201b in Participants With Lymphomas
NCT02732275 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-04-28
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
Conditions
- Lymphoma, Malignant
- Non-hodgkin Lymphoma
Interventions
- DRUG
-
DS-3201b
DS-3201 to be administered orally once daily in each 28-day cycle.
- DRUG
-
DS-3201b
DS-3201 to be administered orally once daily in each 28-day cycle at the recommended dose for expansion.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Daiichi Sankyo Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Global Clinical Leader, MD · Daiichi Sankyo
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2022-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
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