Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL

• Status: Completed
• Trial end date: 2016-01-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Ono Pharmaceutical Co. Ltd

Criteria

Key Inclusion Criteria:

1. 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.

2. Age ≥ 18 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Key Exclusion Criteria:

1. Central nervous system (CNS) lymphoma.

2. Women who are pregnant or lactating.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.