NCT03123393

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	TAK-659	TAK-659 Tablets

Timeline

• Start date: 2017-10-10
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2017-04-21
• Last updated: 2023-02-08
• Results posted: 2020-09-16

Locations

41 sites across 6 countries: United States, Canada, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study