NCT02447380

Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Advanced Gastric Adenocarcinoma Patients With MET Overexpression as a Second-line Treatment

SAMSUNG MEDICAL CENTER

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Phase II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced gastric adenocarcinoma patients with MET overexpression as a second-line treatment. Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor. Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days as one cycle. Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks. To investigate the efficacy of volitinib when given in combination with docetaxel in patients with advanced gastric adenocarcinoma harboring MET overexpression.

Detailed description

In a xenograft model Hs746T with c-Met gene amplification, suboptimal doses 0.6 mg/kg volitinib and 3 mg/kg docetaxel induced TGI of 55.8% and 80.8%, respectively, whereas combination resulted in a TGI by 101.1%, and statistical significance was seen between combination group and either of mono-therapy group. Plasma exposures of volitinib and docetaxel were determined after last dose at the end of study, and there was no significant difference between combination and single agent on exposures of either volitinib or docetaxel. More importantly, combination was well tolerant and no body weight loss was found in the animals. These results suggested that it would be worthwhile to study the combination use of volitinib and docetaxel in clinic.

Conditions

• Advanced Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AZD6094	AZD6094 600MG qd
DRUG	Docetaxel	Docetaxel 60 mg/m2

Timeline

• Start date: 2017-07-10
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2015-05-18
• Last updated: 2019-12-30

Locations

1 site across 1 country: South Korea