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

c-MET Positive Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435108
• Other study ID #: 2014-03-117-003
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2015
• Last updated: February 16, 2017
• Start date: May 15, 2014
• Est. completion date: July 15, 2016

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 15, 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• c-MET Positive Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• crizotinib
crizotinib 250mg bid daily

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		expected average of 24 weeks
Secondary	overall response rate		up too 100 weeks
Secondary	overall survival		up too 100 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		up too 100 weeks