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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.
Full 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.
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Inclusion criteria
Provision of fully informed consent prior to any study specific procedures.
Patients must be ≥20 years of age.
Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after first-line therapy.
Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
Provision or availability of biopsy sample for analysis; e.g mandatory pre-treatment biopsy, or available diagnostic biopsy of sufficient quantity/quality
Patients with MET overexpression
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
ECOG performance status 0-1.
Patients must have a life expectancy ≥ 3 months from proposed first dose date.
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. for women of childbearing potential.
Provision of consent for mandatory biopsy at progression
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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