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Spots Global Cancer Trial Database for DS-3201b in Participants With Lymphomas

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Trial Identification

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

Interventions

DS-3201b

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Global Clinical Leader, MD

Affiliation: Daiichi Sankyo

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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