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Brief Title: DS-3201b in Participants With Lymphomas
Official Title: A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas
Study ID: NCT02732275
Brief Summary: 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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-shi, Aichi, Japan
National Cancer Center Hospital East, Kahiwa-shi, Chiba, Japan
Iwate Medical University Hospital, Morioka-shi, Iwate, Japan
Imamura General Hospital, Kagoshima-shi, Kagoshima, Japan
Kagoshima University Hospital, Kagoshima-shi, Kagoshima, Japan
Kumamoto University Hosipital, Kumamoto-shi, Kumamoto, Japan
Nagasaki University Hospital, Nagasaki-shi, 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, Chuo Ku, Toyko, Japan
Name: Global Clinical Leader, MD
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR