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

Phase 2

Completed

• Conditions: c-MET Positive Gastric Cancer
• Interventions: Drug: crizotinib

• Registration Number: NCT02435108
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-15
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-06
• Primary Completion: 2016-01
• Study Completion: 2016-07-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
crizotinib arm	crizotinib	crizotinib medication

Primary Outcome Measures

Name	Time	Method
progression-free survival	expected average of 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical center; 🇰🇷 Seoul, Korea, Republic of