At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 29 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 Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects With Relapsed/Refractory B-cell Malignancies
In Brief
A Phase 1 clinical trial evaluating Tirabrutinib for Relapsed/Refractory B-cell Malignancies. Completed, enrolled 29 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/Refractory B-cell Malignancies
CountriesFrance, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartSep 2015
Primary CompletionDec 2020
TodayJul 2026
First PostedMay 29, 2015
Enrollment StartSep 10, 2015
Primary CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 11.1 years ago
Interventions
Tirabrutinibdrug
Tablets or capsules administered orally