NCT02732275

DS-3201b in Participants With Lymphomas

A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2016-03-31
• Primary completion: 2022-12-31
• Completion: 2026-12-31
• First posted: 2016-04-08
• Last updated: 2025-02-07

Locations

20 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study