A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
NCT ID: NCT02435108
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
2 participants
INTERVENTIONAL
2014-05-15
2016-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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crizotinib arm
crizotinib medication
crizotinib
crizotinib 250mg bid daily
Interventions
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crizotinib
crizotinib 250mg bid daily
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Jeeyun Lee
MD, PhD, Division of hematology-oncology, Department of medicine,
Principal Investigators
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Jeeyun Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical center
Seoul, , South Korea
Countries
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Other Identifiers
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2014-03-117-003
Identifier Type: -
Identifier Source: org_study_id
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