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

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ClinicalTrials.gov Identifier: NCT02435108
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
c-MET Positive Gastric Cancer Drug: crizotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Crizotinib in Patients With c-MET Positive Gastric Adenocarcinoma as a Third-line Chemotherapy
Actual Study Start Date : May 15, 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Arm Intervention/treatment
Experimental: crizotinib arm
crizotinib medication
Drug: crizotinib
crizotinib 250mg bid daily




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: expected average of 24 weeks ]

Secondary Outcome Measures :
  1. overall response rate [ Time Frame: up too 100 weeks ]
  2. overall survival [ Time Frame: up too 100 weeks ]
  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up too 100 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435108


Locations
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Korea, Republic of
Samsung Medical center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jeeyun Lee, MD, PhD Samsung Medical Center

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Responsible Party: Jeeyun Lee, MD, PhD, Division of hematology-oncology, Department of medicine,, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02435108     History of Changes
Other Study ID Numbers: 2014-03-117-003
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Jeeyun Lee, Samsung Medical Center:
MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining

Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action