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

NCT02435108 | Completed Phase 2

• 1 other identifier: 2014-03-117-003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

c-MET Positive Gastric Cancer

Keywords

MET poisitivity is defined as at least half of tumor cells show weak, moderate or high staining

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  expected average of 24 weeks

Secondary Outcomes (3)

• overall response rate

  up too 100 weeks

• overall survival

  up too 100 weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  up too 100 weeks

Study Arms (1)

crizotinib arm

EXPERIMENTAL

crizotinib medication

Drug: crizotinib

Interventions

crizotinib DRUG

crizotinib 250mg bid daily

crizotinib arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Jeeyun Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Division of hematology-oncology, Department of medicine,

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: May 6, 2015
• Study Start: May 15, 2014
• Primary Completion: January 1, 2016
• Study Completion: July 15, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

KR (1)