Back to resultsA Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
Primary Purpose
c-MET Positive Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
crizotinib
Sponsored by
About this trial
This is an interventional treatment trial for c-MET Positive Gastric Cancer focused on measuring MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining
Eligibility Criteria
Inclusion Criteria:
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy.
- c-MET positive gastric cancer
- ECOG PS 0-2
- At least one measurable disease
- Proper organ function
Exclusion Criteria:
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- 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
- 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)
- known history of hypersensitivity to study drugs
Sites / Locations
- Samsung Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
crizotinib arm
Arm Description
crizotinib medication
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
overall response rate
overall survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT02435108
First Posted
January 15, 2015
Last Updated
February 16, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02435108
Brief Title
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
Official Title
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
c-MET Positive Gastric Cancer
Keywords
MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
crizotinib arm
Arm Type
Experimental
Arm Description
crizotinib medication
Intervention Type
Drug
Intervention Name(s)
crizotinib
Intervention Description
crizotinib 250mg bid daily
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
expected average of 24 weeks
Secondary Outcome Measure Information:
Title
overall response rate
Time Frame
up too 100 weeks
Title
overall survival
Time Frame
up too 100 weeks
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
up too 100 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of fully informed consent prior to any study specific procedures.
Patients must be ≥20 years of age.
Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second line therapy.
c-MET positive gastric cancer
ECOG PS 0-2
At least one measurable disease
Proper organ function
Exclusion Criteria:
severe co-morbid illness and/or active infections
pregnant or lactating women
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
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)
known history of hypersensitivity to study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeeyun Lee, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
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