Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
Status and phase
Completed
Phase 1
Conditions
Chronic Lymphocytic Leukaemia
Non Hodgkins Lymphoma
Treatments
Drug: Tirabrutinib
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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).
Enrollment
90 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Key Exclusion Criteria:
- Central nervous system (CNS) lymphoma.
- Women who are pregnant or lactating.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
90 participants in 17 patient groups
Tirabrutinib 20 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 40 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 80 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 160 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 320 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 400 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 500 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 600 mg Once Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 300 mg Twice Daily (CLL)
Experimental group
Description:
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 20 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 40 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 80 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 160 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 320 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 480 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 600 mg Once Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
Treatment:
Drug: Tirabrutinib
Tirabrutinib 240 mg Twice Daily (NHL)
Experimental group
Description:
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
Treatment:
Drug: Tirabrutinib
Trial contacts and locations
6
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Data sourced from clinicaltrials.gov
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