Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

Eligibility Criteria

Inclusion Criteria:

• Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung

• Positive for translocation or inversion events involving the ALK gene locus

• No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids

• Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.

• 18 years of age or older with the exception of India which has an upper age limit of 65 years old

Exclusion Criteria:

• Current treatment on another therapeutic clinical trial.

• Prior therapy directly targeting ALK.

• Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.

• Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.

• Pregnancy or breastfeeding.

• Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.

• Known HIV infection

• Known interstitial lung disease or interstitial fibrosis

• Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call Center

Study Director

Pfizer CT.gov Call Center

Ph: 1-800-718-1021

U.S.A.
California
	Loma Linda
	Loma Linda University Cancer Center-Schuman Pavilion
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
	Loma Linda University Medical Center Pharmacy
	Records Management Only- Loma Linda Cancer Center
Florida
	Orlando
	Cancer Institute of Florida
	Florida Hospital Cancer Institute at Florida Hospital Orlando
	Hematology and Oncology Consultants, PA
	Investigational Drug Services
Georgia
	Atlanta
	Georgia Cancer Specialists - Northside Office
	Decatur
	Georgia Cancer Specialists - Stemmer Building
	Macon
	Georgia Cancer Specialists
	Marietta
	Georgia Cancer Specialist - Marietta
	Sandy Springs
	Georgia Cancer Specialists
Illinois
	Chicago
	University of Chicago Cancer Research Center
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
	Methodist Hospital
Maine
	Biddeford
	Maine Center for Cancer Medicine
	Brunswick
	Maine Center for Cancer Medicine
	Sanford
	Maine Center for Cancer Medicine
	Scarborough
	Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
	Dana-Farber/Brigham and Women's Cancer Center
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
	Farmington Hills
	Karmanos Cancer Institute at Farmington Hills
Missouri
	Creve Coeur
	Siteman Cancer Center - West County
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
	St. Peters
	Siteman Cancer Center
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
New Mexico
	Albuquerque
	University of New Mexico Cancer Center
	UNM Eye Clinic
	Las Cruces
	Memorial Medical Center
New York
	Lake Success
	NSLIJ Health System/Monter Cancer Center
	Manhasset
	Don Monti Comprehensive Cancer Center at North Shore University Hospital
	New Hyde Park
	Long Island Jewish Medical Center
	Oneida
	Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
	Oswego
	Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
	Syracuse
	Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
	SUNY Upstate Medical University Hospital
Oregon
	Beaverton
	OHSU Knight Cancer Institute
	Gresham
	OHSU Knight Cancer Institute
	Portland
	Knight Cancer Institute at Oregon Health and Science University
	Tualatin
	OHSU Knight Cancer Institute
Tennessee
	Nashville
	Henry-Joyce Cancer Clinic
	Vanderbilt Oncology Pharmacy
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
	UT Southwestern University Hospital - Zale Lipshy
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Australia
New South Wales
	Camperdown
	Sydney Cancer Centre at Royal Prince Alfred Hospital
	St. Leonards
	Department of Medical Oncology
Queensland
	Chermside
	The Prince Charles Hospital
	Townsville
	Townsville Hospital
South Australia
	Adelaide
	Royal Adelaide Hospital Cancer Centre
Victoria
	East Melbourne
	Peter MacCallum Cancer Centre
	Frankston
	Peninsula Oncology Centre
Austria
	Salzburg
	St. Johanns-Spital
	Wels
	KH der Kreuzschwestern Wels-Grieskirchen
Belgium
	Brussel
	Universitair Ziekenhuis Brussel / Medische Oncologie
	Brussels
	Cliniques Universitaires Saint-Luc
	Bruxelles
	Institut Jules Bordet
	Charleroi
	Centre Hospitalier Notre Dame et Reine Fabiola, Service d'Oncologie
	Edegem
	Universitair Ziekenhuis Antwerpen
	Gent
	Universitair Ziekenhuis Gent
	Liege
	CHU Liege
	Roeselare
	Heilig Hart Ziekenhuis Roeselare-Menen
Brazil
	Ijui
	Associacao Hospital de Caridade de Ijui
	Porto Alegre
	Hospital Sao Lucas da PUCRS
	Rio de Janeiro
	Instituto Nacional de C?er - INCA
	Instituto Nacional do Cancer - INCA
Sao Paulo
	Barretos
	Fundacao Pio XII Hospital de Cancer de Barretos
	Sao Paulo
	Instituto do C?er do Estado de S?Paulo Octavio Frias de Oliveira - ICESP
Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
Nova Scotia
	Halifax
	Nova Scotia Cancer Centre
	QEII Health Sciences Centre
Ontario
	Oshawa
	R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
Quebec
	Montreal
	Jewish General Hospital - Montreal
	Montreal General Hospital
	Royal Victoria Hospital - Montreal
	St. Mary's Hospital Centre
	Ste-Foy
	Hopital Laval
China
	Beijing
	307 Hospital of PLA
	Cancer Institute Hospital, Chinese Academy of Medical Sciences
	Chengdu
	West China Hospital at Sichuan University
	Guangzhou
	Guangdong Provincial People's Hospital
	Nanjing
	Nanjing Bayi Hospital
	No.81 Hospital of the PLA
	Shanghai
	Shanghai Chest Hospital
	Shanghai Pulmonary Hospital/Dept. of Oncology
	Wuhan
	Tongji Medical University
Finland
	Helsinki
	Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka
	Pori
	Satakunnan keskussairaala/Keuhkosairauksien osasto A4
	Tampere
	Tampereen yliopistollinen sairaala
France
	Bobigny Cedex
	Hopital Avicenne
	Caen Cedex
	CHU de la C?de Nacre
	Grenoble Cedex
	CHU Grenoble
	Lille
	Centre Oscar Lambret
	Lyon Cedex 08
	Centre Leon Berard
	Marseille Cedex 20
	APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Th?peutiques
	Montpellier
	Hopital Arnaud de Villeneuve
	Paris cedex 20
	Hopital Tenon
	Strasbourg
	Nouvel Hopital Civil - HSU - P?de Pathologie Thoracique - Service de Pneumologie
Germany
	Bad Berka
	Zentralklinik Bad Berka
	Berlin
	Charite - Campus Charite Mitte
	Heidelberg
	Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren
	Mainz
	Universitaetsklinik Mainz III. Med. Klinik, Abt. Pneumologie
	Moenchengladbach
	Kliniken Maria Hilf GmbH
	Oldenburg
	Pius Hospital - Oldenburg
	Wiesbaden
	Dr. Horst-Schmidt-Kliniken
Hong Kong
	Kowloon
	Queen Elizabeth Hospital
	Shatin
	Prince of Wales Hospital
India
	Ahmedabad,
	The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),
Ireland
	Dublin
	Department of Medical Oncology
	Dublin 8
	Aseptic Compounding Unit
Italy
	Aviano (PN)
	Centro di Riferimento Oncologico - Aviano
	Bari
	Istituto dei tumori Giovanni Paolo II
	Bologna
	Ospedale Maggiore Bellaria
	Catanzaro
	Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella, Unit?perativa di Oncologia
	Livorno
	UO di Oncologia, Ospedale Civile, Azienda USL 6 di Livorno
	Milano
	Dipartimento di Medicina,Unita' di Farmacologia Clinica Nuovi Farmaci,
	Fondazione Istituto Nazionale dei Tumori
	Ospedale Niguarda Ca'Granda
	Napoli
	A.O.R.N. Dei Colli Plesso Monaldi
	Orbassano (TO)
	Azienda Ospedale S. Luigi at University of Torino
	Parma
	Azienda Ospedaliera Di Parma
	Reggio Emilia
	Arcispedale S. Maria Nuova
	Roma
	Istituto Regina Elena
	Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
	UO Oncologia Toracica 1, Dipartimento di Malattie Polmonari, Padiglione Maroncelli
Luxembourg
	Luxembourg
	Centre Hospitalier de Luxembourg
Mexico
	Mexico
	Instituto Nacional de Cancerologia
Netherlands
	Amsterdam
	Vrije Universiteit Medisch Centrum
	Maastricht
	Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose
	's Hertogenbosch
	Jeroen Bosch Ziekenhuis
	s-Hertogenbosch
	Jeroen Bosch Ziekenhuis, locatie Groot Ziekengasthuis
Norway
	Oslo
	Oslo universitetssykehus HF - Radiumhospitalet
Peru
	San Isidro
	Clinica Anglo Americana/Centro de Investigacion Oncologia CAA
Portugal
	Coimbra
	Hospitais da Universidade de Coimbra (HUC)
	Lisboa
	Centro Hospitalar Lisboa Norte, EPE.
	Instituto Portugu?de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.
	Vila Nova de Gaia
	Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Republic of Korea
	Seoul
	Asan Medical Center - University of Ulsan College of Medicine
	Samsung Medical Center
	Seoul National University Hospital
Republic of Singapore
	Singapore
	Cancer Institute at National University Hospital
	National Cancer Centre - Singapore
	Parkway Cancer Centre at Gleneagles Hospital
Republic of South Africa
	Parktown
	University of Witwatersrand Faculty of Health Sciences
Russia
	Moscow
	Russian Academy of Medical Sciences Cancer Research Center
	Saint-Petersburg
	Pavlov State Medical University
	Research Institute of Pulmonology
	Russian Scientific Center of Radiology and Surgery Technologies
	St. Petersburg City Oncological Dispensary
Spain
	Barcelona
	Hospital Clinic de Barcelona
	Vall d'Hebron University Hospital
	Elche
	Hospital Universitario de Elche
	Las Palmas de Gran Canaria
	Hospital Universitario Insular de Gran Canaria
	Madrid
	Hospital Ramon y Cajal
	Hospital Universitario 12 de Octubre
	Malaga
	Hospital Universitario Virgen de la Victoria
	Sevilla
	Hospital Universitario Virgen Macarena
	Zaragoza
	Hospital Clinico Universitario Lozano Blesa
Switzerland
	Basel
	Universitaetsspital-Basel
	Luzern
	Luzerner Kantonsspital
	Winterthur
	Kantonsspital Winterthur
Taiwan
	Kaohsiung Hsien
	Chang Gung Memorial Hospital - Kaohsiung
	Taichung
	China Medical University Hospital
	Taichung Veterans General Hospital, Comprehensive Cancer Center
	Taoyuan
	Chang-Gung Memorial Hospital - Linkou
Ukraine
	Dnipropetrovsk
	Department of Oncology and Medical Radiology of Dnipropetrovsk State Medical Academy
	Department of Oncology and Medical Radiology of SI "Dnipropetrovsk State Medical Academy of
	Kyiv
	Kyiv City Clinical Oncologic Center/Department of Chemotherapy
	Lviv
	Lviv State Medical University Regional Oncology Centre
United Kingdom
	Aberdeen
	Aberdeen Royal Infirmary
	Cambridge
	Addenbrooke's Hospital
	Glasgow
	Beatson West of Scotland Cancer Centre
	Hertfordshire
	Queen Elizabeth II Hospital
	Manchester
	Christie Hospital
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
	Stevenage
	Lister Hospital

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01154140
Information obtained from ClinicalTrials.gov on May 06, 2013

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