At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 90 enrolled
Drug / intervention
Tirabrutinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Tirabrutinib for Non Hodgkins Lymphoma and Chronic Lymphocytic Leukaemia. Completed, enrolled 90 participants across 6 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United Kingdom
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartAug 2012
Primary CompletionFeb 2015
Study CompletionJan 2016
TodayJul 2026
First PostedAug 7, 2012
Enrollment StartAug 17, 2012
Primary CompletionFeb 23, 2015
Study CompletionJan 11, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.9 years ago
Interventions
Tirabrutinibdrug
Capsules administered orally