Conditions: Non Hodgkins Lymphoma Chronic Lymphocytic Leukaemia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily. arm 2: Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily. arm 3: Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. arm 4: Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. arm 5: Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. arm 6: Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. arm 7: Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. arm 8: Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. arm 9: Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. arm 10: Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily. arm 11: Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. arm 12: Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. arm 13: Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. arm 14: Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. arm 15: Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. arm 16: Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. arm 17: Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.

Interventions: intervention 1: Tirabrutinib
Intervention descriptions: intervention 1: Capsules administered orally

Protocol document: