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

NCT ID: NCT02435108

Last Updated: 2017-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-15

Study Completion Date

2016-07-15

Brief Summary

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

Detailed Description

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Conditions

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c-MET Positive Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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crizotinib arm

crizotinib medication

Group Type EXPERIMENTAL

crizotinib

Intervention Type DRUG

crizotinib 250mg bid daily

Interventions

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crizotinib

crizotinib 250mg bid daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeeyun Lee

MD, PhD, Division of hematology-oncology, Department of medicine,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeeyun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2014-03-117-003

Identifier Type: -

Identifier Source: org_study_id

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