Date: 2017-03-09
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: BeiGene (China)
Product: BGB-3111
Action
mechanism:
- kinase inhibitor/Bruton tyrosine kinase inhibitor. BGB-3111 is an investigational, oral, highly selective and potent inhibitor of Bruton tyrosine kinase (BTK). Bruton tyrosine kinase (BTK), a member of the TEC family of kinases, is a signaling molecule positioned within the B-cell receptor signaling cascade. BTK is predominantly expressed in B lymphocytes at various stages of development. Activation of BTK in B cells initiates a series of signaling events that leads to the expression of genes involved in proliferation and survival. Several BTK inhibitors have demonstrated sustained antitumor responses as a single agent in patients with B-cell malignancies.
- BGB-3111 is also currently being evaluated in a pivotal Phase II clinical trial in Chinese patients with relapsed or refractory mantle cell lymphoma (MCL) and a global Phase III clinical trial in comparison with ibrutinib for the treatment of patients with Waldenström’s macroglobulinemia.
Disease: relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Therapeutic
area: Cancer - Oncology
Country: China
Trial
details:
Latest
news:
- • On March 9, 2017, BeiGene announced the dosing of the first patient in a pivotal clinical trial of BGB-3111 in Chinese patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The Phase II single-arm, open-label, multi-center study is designed to investigate the efficacy and safety of BGB-3111 in patients with relapsed or refractory CLL/SLL. The trial’s primary endpoint is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug. Secondary endpoints include progression free survival, duration of response, time to response, safety, and tolerability. Professor Jianyong Li of the Jiangsu Province Hospital, the first Affiliated Hospital with Nanjing Medical University, is the lead principal investigator of the trial.
Is
general: Yes
