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DS-3201b in Participants With Lymphomas
Sponsor: Daiichi Sankyo Co., Ltd.
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
Official title: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2016-03-31
Completion Date
2026-12-31
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (20)
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