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TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:
Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy

Clinical Trial Summary

The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.

Clinical Trial Description

The drug being tested is TAK-659. This study will evaluate overall response rate (ORR) in participants with relapsed or refractory DLBCL who take TAK-659. The study will enroll approximately 122 participants. Participants will be assigned to: • TAK-659 60 mg to 100 mg All participants will be asked to take the tablets of TAK-659 at the same time each day throughout the study in a 28-day cycle. This multi-center trial will be conducted in the United States, United Kingdom, Spain, Italy, France, Canada, Germany. The overall time to participate in this study is approximately 48 months. Participants will be assessed for disease response and progression during the PFS follow-up every 3 months after end of treatment (for participants who discontinue due to reasons other than disease progression) and OS follow-up every 3 months from the last dose of study drug until death or conclusion of the study, whichever occurs first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03123393
Study type Interventional
Source Calithera Biosciences, Inc
Contact
Status Terminated
Phase Phase 2
Start date October 10, 2017
Completion date December 17, 2019
View Details
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