Phase 1
Completed N=90
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
Source: ClinicalTrials.gov NCT01659255 ↗Enrolled (actual)
90
Serious AEs
44.4%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Participants Experiencing Dose-Limiting Toxicities — 0.0; 0.0; 0.0; 0.0 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Dose-Limiting Toxicities |
0.0; 0.0; 0.0; 0.0; 0.0; 33.3 | — |
| SECONDARY Overall Response Rate |
85.7; 0.0; 0.0; 33.3; 50.0; 31.4 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib |
73.4; 164.5; 241; 539.6; 1181.6; 826.5 | — |
| SECONDARY PK Parameter: AUCtau of Tirabrutinib |
306.4; 660.1; 762; 2681.8; 5664.8; 5259.5 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01659255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.