c-MET Positive Gastric CancerPhase 2NCT02435108
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
A Phase 2 study testing crizotinib in people with c-MET Positive Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- c-MET Positive Gastric Cancer
- What is being tested?
- crizotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2014to 15 Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.
- Conditions
- c-MET Positive Gastric Cancer
- Being tested
- crizotinib
- Keywords
- MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizotinibDrug
crizotinib 250mg bid daily
| Study group | Role | What they receive |
|---|---|---|
| crizotinib arm | Experimental | crizotinib medication Receives: Drug: crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: expected average of 24 weeks
Secondary outcomes (3)
overall response rate
Measured: up too 100 weeks
overall survival
Measured: up too 100 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up too 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start15 May 2014
- Primary completionJan 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for c-MET Positive Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435108
- Sponsor's protocol ID
- 2014-03-117-003
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2015
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
- ClinicalTrials.gov ID
- NCT02435108
- Acronym / sponsor ID
- 2014-03-117-003
- Conditions
- c-MET Positive Gastric Cancer
- Keywords
- MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 May 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| crizotinib arm | Experimental | Drug: crizotinibcrizotinib medication |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crizotinibcrizotinib 250mg bid daily | Drug | crizotinib arm |
Primary outcome
progression-free survival
Time frame: expected average of 24 weeks
3 secondary outcomes
overall response rate
Time frame: up too 100 weeks
overall survival
Time frame: up too 100 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up too 100 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
Related trials for c-MET Positive Gastric Cancer
RecruitingPhase 2
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Solid Tumors, Advanced Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeeyun Lee, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing crizotinib in people with c-MET Positive Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: expected average of 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.