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ACTIVE NOT RECRUITING
NCT02732275
PHASE1

DS-3201b in Participants With Lymphomas

Sponsor: Daiichi Sankyo Co., Ltd.

View on ClinicalTrials.gov

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

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.

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