drugset / Trial / NCT02449551

Study of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment

NCT02449551

Phase 2 Completed 16 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

Summary

Volitinib is a potent and selective small molecule c-Met kinase inhibitor. Volitinib was found to inhibit c-Met kinase at the enzyme and cell levels with IC50s of 4 nM for both enzyme and Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, volitinib was found to inhibit cell growth in vitro against tumors with c-Met gene amplification in the absence of HGF stimulation with IC50s generally below 10 nM. It also potently inhibited HGF-stimulated cell proliferation against tumors with c-Met overexpression or carrying a HGF/c-Met autocrine loop. This study is a single-arm, phase II study of votilinib in patients with advanced gastric adenocarcinoma harboring MET amplification as a third line treatment Volitinib 800 mg will be administered orally once a day for 21 days as one cycle. To investigate the efficacy of volitinib in patients with advanced gastric adenocarcinoma harboring MET amplification.

Timeline

Start
2016-02-10
Primary completion
2020-12-30
Completion
2021-08-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Savolitinib Small molecule 800 mg Oral