c-MET Positive Gastric Cancer
Conditions
Keywords
MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining
Brief summary
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.
Interventions
DRUGcrizotinib
crizotinib 250mg bid daily
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of fully informed consent prior to any study specific procedures. 2. Patients must be ≥20 years of age. 3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy. 4. c-MET positive gastric cancer 5. ECOG PS 0-2 6. At least one measurable disease 7. Proper organ function
Exclusion criteria
1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. History of documented congestive heart failure; angina pectoris requiring medication; evidence of tranasmural myocardial infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high risk of uncontrollable arrhythmia 4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid) 5. known history of hypersensitivity to study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | expected average of 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate | up too 100 weeks |
| overall survival | up too 100 weeks |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up too 100 weeks |
Countries
South Korea
Outcome results
None listed