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Completed

NCT Number: NCT02435108

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

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

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Key information

Conditions

c-MET Positive Gastric Cancer Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crizotinib

Drug

crizotinib 250mg bid daily

Primary outcomes

  1. progression-free survival

    Time frame: expected average of 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 6, 2015
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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