Date: 2018-07-24
Type of
information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: BeiGene (China)
Product: pamiparib (BGB-290)
Action
mechanism:
- PARP inhibitor . Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models. Pamiparib is being evaluated in a pivotal clinical trial in China. It is currently in global clinical development as a monotherapy, and in combination with other agents, including BeiGene’s investigational anti-PD1 antibody, tislelizumab (BGB-A317), for a variety of solid tumor malignancies.
Disease: advanced gastric cancer
Therapeutic
area: Cancer - Oncology
Country: China, France, Hungary, Spain, USA
Trial
details:
Latest
news:
- • On July 24, 2018, BeiGene announced that the first patient was dosed in a global Phase 3 clinical trial of pamiparib, an investigational PARP inhibitor, as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer who responded to platinum-based first-line chemotherapy.
- The global Phase 3, randomized, double-blind, placebo-controlled trial in China, the U.S., Europe, Japan, Australia, and Singapore, is designed to compare the efficacy and safety of pamiparib to placebo as maintenance therapy in approximately 540 patients with advanced gastric cancer who have responded to first-line platinum-based chemotherapy. The primary endpoint of the trial is progression-free survival (PFS) by blinded independent review committee assessment. Overall survival (OS) is a key secondary endpoint as are progression after the next line of therapy (PFS2) and safety and tolerability
Is
general: Yes
