The purpose of this study is to evaluate the effects of an investigational drug called tirabrutinib when given alone for the treatment of primary central nervous system lymphoma (PCNSL) in individuals who have already received at least one prior chemotherapy regimen. The study will look at the effectiveness and safety of the drug when given to adult participants with relapsed/refractory PCNSL. Relapsed or refractory means lack of response or disease progression on last prior therapy. Primary central nervous system lymphoma is an aggressive cancer that forms in the lymph tissue of the brain and/or the spinal cord. Tirabrutinib acts by blocking an enzyme called Bruton’s tyrosine kinase or BTK, which interferes with the growth of cancer cells. Researchers will also evaluate how tirabrutinib behaves inside the human body and how it is removed from the human body (pharmacokinetics) by measuring the amount of the drug in the patient’s blood.
What is the full name of this clinical trial?
ONO-4059-09: An Open-Label, Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma *