NCT02457559

Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies

An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects With Relapsed/Refractory B-cell Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the prior dosing regimen from the parent study.

Conditions

• Relapsed/Refractory B-cell Malignancies

Interventions

Type	Name	Description
DRUG	Tirabrutinib	Tablets or capsules administered orally

Timeline

• Start date: 2015-09-10
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2015-05-29
• Last updated: 2022-03-24
• Results posted: 2022-03-24

Locations

6 sites across 2 countries: France, United Kingdom

Regulatory

• FDA-regulated drug study