- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02435108
A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
February 16, 2017 updated by: Jeeyun Lee, Samsung Medical Center
This is a pilot study of crizotinib in patients with c-MET positive gastric adenocarcinoma.
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: crizotinib arm
crizotinib medication
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crizotinib 250mg bid daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: expected average of 24 weeks
|
expected average of 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate
Time Frame: up too 100 weeks
|
up too 100 weeks
|
overall survival
Time Frame: up too 100 weeks
|
up too 100 weeks
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up too 100 weeks
|
up too 100 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
July 15, 2016
Study Registration Dates
First Submitted
January 15, 2015
First Submitted That Met QC Criteria
April 30, 2015
First Posted (Estimate)
May 6, 2015
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-03-117-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on c-MET Positive Gastric Cancer
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Fujian Cosunter Pharmaceutical Co. LtdUnknownSolid Tumor | C-Met Mutation-Related TumorsChina
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Symphogen A/SCompletedNSCLC | Non Small Cell Lung Cancer | Oncology | MET Gene Mutation | MET Gene AmplificationUnited States, Korea, Republic of, Denmark, Hong Kong, Taiwan, Spain
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Armando Santoro, MDCompletedColorectal Cancer Metastatic | C-met OverexpressionItaly
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Triumvira Immunologics, Inc.Merck Sharp & Dohme LLCActive, not recruitingHER2 Positive Gastric Cancer | Metastatic HER2 Positive Gastroesophageal Junction CancerUnited States, Canada
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Novartis PharmaceuticalsTerminatedc-MET Inhibitor; PI3K Inhibitor, PTEN Mutations, Homozygous Del. of PTEN or PTEN Neg. by IHC, c-Met Ampli. by FISH, INC280, BKM120, Buparlisib; Recurrent GBMSpain, Switzerland, Germany, United States, Netherlands
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Amsterdam UMC, location VUmcAstraZenecaRecruitingBreast Cancer | Gastric Cancer | Metastatic Breast Cancer | HER2-positive Breast Cancer | HER2-positive Gastric Cancer | Metastatic Gastric CancerNetherlands
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Henan Cancer HospitalRongchang Biopharmaceutical; Zhengda Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHER2-positive Gastric Cancer | Advanced Gastric CarcinomaChina
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AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
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Turning Point Therapeutics, Inc.Active, not recruitingAdvanced Solid Tumor | Metastatic Solid Tumors | MET Gene AlterationsUnited States, France, Korea, Democratic People's Republic of, Korea, Republic of, Spain
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Peking UniversityNot yet recruitingHER2 Positive Gastric CancerChina
Clinical Trials on crizotinib
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...Not yet recruitingNon-Small Cell Lung CancerUnited States
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PfizerWithdrawnCarcinoma, Renal Cell | Glioblastoma | Carcinoma, Hepatocellular
-
PfizerCompletedRenal ImpairmentUnited States
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PfizerCompleted
-
European Organisation for Research and Treatment...PfizerCompletedLocally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma | Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor | Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1 | Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma | Locally Advanced... and other conditionsFrance, Belgium, Netherlands, Germany, United Kingdom, Italy, Norway, Poland, Slovakia, Slovenia
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PfizerCompleted
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PfizerCompletedHealthy VolunteerUnited States
-
Jun ZhuPeking University First Hospital; Peking University People's Hospital; Peking... and other collaboratorsWithdrawnSystemic Anaplastic Large-Cell LymphomaChina