A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: c-MET Positive Gastric Cancer

Treatments: Drug: crizotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02435108

2014-03-117-003

Details and patient eligibility

About

This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.

Enrollment: 2 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

crizotinib arm

Experimental group

Description:

crizotinib medication

Treatment:

Drug: crizotinib