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Last Updated: May 2, 2024

CLINICAL TRIALS PROFILE FOR TIRABRUTINIB

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Clinical Trials for Tirabrutinib

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01659255 ↗	Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL	Completed	Ono Pharmaceutical Co. Ltd	Phase 1	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).
NCT01659255 ↗	Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL	Completed	Gilead Sciences	Phase 1	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).
NCT02457559 ↗	Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies	Completed	Gilead Sciences	Phase 1	This study will determine the long-term safety, tolerability, and efficacy of tirabrutinib in adults in a prior tirabrutinib study and whose disease had not progressed on the parent study. The dosing regimen will be based on the prior dosing regimen from the parent study.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for Tirabrutinib

Condition Name

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Condition Name for
Intervention	Trials
Chronic Lymphocytic Leukemia	2
Relapsed/Refractory B-cell Malignancies	1
Rheumatoid Arthritis	1
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Condition MeSH

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Condition MeSH for
Intervention	Trials
Leukemia, Lymphoid	3
Leukemia, Lymphocytic, Chronic, B-Cell	3
Leukemia	3
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Clinical Trial Locations for Tirabrutinib

Trials by Country

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Trials by Country for
Location	Trials
United States	49
Germany	11
United Kingdom	5
France	4
Poland	1
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Trials by US State

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Trials by US State for
Location	Trials
Pennsylvania	4
Michigan	3
Kentucky	3
California	3
North Carolina	3
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Clinical Trial Progress for Tirabrutinib

Clinical Trial Phase

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Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	5
Phase 1	4
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Clinical Trial Status

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Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	6
Withdrawn	1
Active, not recruiting	1
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Clinical Trial Sponsors for Tirabrutinib

Sponsor Name

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Sponsor Name for
Sponsor	Trials
Gilead Sciences	8
Ono Pharmaceutical Co. Ltd	6
German CLL Study Group	2
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Sponsor Type

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Sponsor Type for
Sponsor	Trials
Industry	15
Other	2
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