NCT01659255

Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL

An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Conditions

• Non Hodgkins Lymphoma
• Chronic Lymphocytic Leukaemia

Interventions

Type	Name	Description
DRUG	Tirabrutinib	Capsules administered orally

Timeline

• Start date: 2012-08-17
• Primary completion: 2015-02-23
• Completion: 2016-01-11
• First posted: 2012-08-07
• Last updated: 2021-03-16
• Results posted: 2021-01-28

Locations

6 sites across 2 countries: France, United Kingdom