Clinical trial NCT00932451: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Official title: Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung Neoplasms ALK gene Crizotinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 1069
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically proven diagnosis of non-small cell lung cancer
* positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
* may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
* Tumors can be measurable or non measurable

Exclusion Criteria:

* prior treatment with PF-02341066
* received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
* current enrollment in another therapeutic clinical trial

Primary outcomes:
measure: Objective Response Rate
timeFrame: 6 years
measure: Percentage of Participants With Adverse Events
timeFrame: 6 years
Secondary outcomes:
measure: Duration of Response (DR)
timeFrame: 6 years
measure: Time to Tumor Response (TTR)
timeFrame: 6 years
measure: Disease Control Rate (DCR)
timeFrame: 6 years
measure: Progression Free Survival (PFS)
timeFrame: 6 years
measure: Overall Survival (OS)
timeFrame: 6 years
measure: Probability of Survival
timeFrame: 6 years
measure: Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182
timeFrame: 6 years
measure: Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)
timeFrame: 6 years
measure: Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)
timeFrame: 6 years
measure: QTc Prolongation in Participants
timeFrame: 6 years
measure: Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.
timeFrame: 6 years
measure: Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores
timeFrame: 6 years
measure: Mean Change From Baseline of QLQ-LC13 Scale Scores
timeFrame: 6 years
measure: Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)
timeFrame: 6 years
measure: Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale
timeFrame: 6 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center - La Jolla
state: California
city: Los Angeles
country: United States
facility: Drug Shipping Address: Ronald Reagen University of California-Los Angeles
state: California
city: Los Angeles
country: United States
facility: Ronald Reagen University of California-Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Opthalmic Oncology Center
state: California
city: Los Angeles
country: United States
facility: University of California-Los Angeles
state: California
city: Orange
country: United States
facility: University of California, Irvine-Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine-Pharmacy
state: California
city: Palo Alto
country: United States
facility: Stanford University-Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest
state: California
city: Santa Monica
country: United States
facility: Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology-Santa Monica
state: California
city: Santa Monica
country: United States
facility: University of California-Los Angeles
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group Inc
state: California
city: Aurora
country: United States
facility: DRUG SHIPMENT: University of Colorado Cancer Center
state: Colorado
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Colorado - Franklin
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente Colorado - Rock Creek
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Center at Yale New Haven, Oncology Pharmacy
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Michael and Dianne Bienes Cancer Center, Holy Cross Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute
state: Florida
city: Lake Worth
country: United States
facility: Cancer Center of South Florida Foundation, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Center (West)
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institution
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists - Administrative Annex
state: Georgia
city: Augusta
country: United States
facility: MCG Health Cancer Center Pharmacy
state: Georgia
city: Augusta
country: United States
facility: MCG Health System Pharmacy (Drug Shipment Only)
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Decatur
country: United States
facility: Georgia Cancer Specialists-Stemmer
state: Georgia
city: Macon
country: United States
facility: Georgia Cancer Specialists-Macon
state: Georgia
city: Marietta
country: United States
facility: Georgia Cancer Specialists-Kennestone
state: Georgia
city: Sandy Springs
country: United States
facility: Georgia Cancer Specialists-Northside
state: Georgia
city: Honolulu
country: United States
facility: OnCare Hawaii, Inc.
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii - Cancer Research Center of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Medical Center East
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center (Attn: J Pi PharmD / A. Patel Pharm D)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital (Drug Shipment Only)
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Harvey
country: United States
facility: Monroe Medical Associates
state: Illinois
city: Tinley Park
country: United States
facility: Monroe Medical Associates
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital Clarian Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Ship drug to: Investigational Drug Services
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Memorial Hospital
state: Indiana
city: Indianopolis
country: United States
facility: Springmill Medical Clinic
state: Indiana
city: Munster
country: United States
facility: Monroe Medical Associates
state: Indiana
city: Munster
country: United States
facility: The Community Hospital
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: The Harry and Jeanette Cancer Research Building
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health National Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Massachusette General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachussetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center, Pharmacy FD B18
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute/Pharmacy
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer lnstitute at Farmington Hllls
state: Michigan
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: St. Peters
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Eye Clinic
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Lake Success
country: United States
facility: NSLIJ Health System/Monter Cancer Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: IP Shipment: CUMC Research Pharmacy
state: New York
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: Oneida
country: United States
facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
state: New York
city: Oswego
country: United States
facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University, Regional Oncology Center
state: New York
city: Syracuse
country: United States
facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
state: New York
city: Chapel Hill
country: United States
facility: UNC Health Care
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals, The University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital Cancer Center
state: North Carolina
city: Huntersville
country: United States
facility: Presbyterian Hospital Huntersville
state: North Carolina
city: Huntersville
country: United States
facility: Southern Oncology Specialists
state: North Carolina
city: Matthews
country: United States
facility: Presbyterian Hospital Matthews
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Hospital East
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Investigational Drug Services
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University James Cancer Hospital and Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: James Care in Kenny
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: East Providence
country: United States
facility: Vincent Armenio, MD
state: Rhode Island
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina - Hollings Cancer Center
state: South Carolina
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (Administration)
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (Pharmacy)
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: The Vanderbilt Chemo Clinic
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern University Hospital - Zale Lipshy
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital - William P. Clements, Jr
state: Texas
city: Houston
country: United States
facility: The University of Texas
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: Lisa Nakatsu, RPh (Drug Shipment Address)
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, Department of Medical Oncology
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
state: Victoria
city: Nedlands
country: Australia
facility: Department of Medical Oncology
state: Western Australia
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
state: Bahia
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Câncer - INCA
state: RJ
city: Ijui
country: Brazil
facility: Associacao Hospital de Caridade de Ijui
state: RS
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Jau
country: Brazil
facility: Fundacao Hospital Amaral Carvalho
state: Sao Paulo
city: Barretos
country: Brazil
facility: Fundacao Pio XII Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente
state: SP
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL
city: Sofia
country: Bulgaria
facility: MBAL Voennomeditsinska Academia, MMA HAT Sofia
city: Sofia
country: Bulgaria
facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
city: Varna
country: Bulgaria
facility: MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Calgary
country: Canada
facility: Alberta Health Services, Holy Cross Site
state: Alberta
city: Calgary
country: Canada
facility: Office of Dr. John McWhae
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Moncton
country: Canada
facility: Dr. Georges-L. Dumont Regional Hospital
state: New Brunswick
city: Moncton
country: Canada
facility: Dr. Leon Richard Oncology Centre
state: New Brunswick
city: Oshawa
country: Canada
facility: RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
state: Ontario
city: Oshawa
country: Canada
facility: Dr. Dana Blakolmer and Associates
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospsital
state: Quebec
city: Montreal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
city: Guangzhou
country: China
facility: SUN Yat-Sen University Cancer Center
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Bayi Hospital
state: Jiangsu
city: Beijing
country: China
facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department
city: Beijing
country: China
facility: 307 Hospital of PLA
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital/Department of Pulmonary Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University / Respiratory Department
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Grenoble Cedex 09
country: France
facility: Hopital Albert Michallon
city: Marseille Cedex 20
country: France
facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
city: NICE Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris cedex 20
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Hospital Cochin
city: St Herblain Cedex
country: France
facility: Centre Rene Gauducheau / Service d'Oncologie Medicale
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl-Gustav-Carus Dresden
city: Essen
country: Germany
facility: Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung
city: Grosshansdorf
country: Germany
facility: Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie
city: Hamburg
country: Germany
facility: Ambulantes Krebszentrum Hamburg
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Koeln
country: Germany
facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Wiesbaden
country: Germany
facility: HSK Dr.- Horst-Schmidt-Kliniken
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion/ Department of Clinical Oncology
state: Crete
city: Exohi
country: Greece
facility: General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department
state: Thessaloniki
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens "Sotiria"
city: Pokfulam
country: Hong Kong
facility: Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
city: Tuen Mun, New Territories
country: Hong Kong
facility: Tuen Mun Hospital, Department of Clinical Oncology
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Pulmonologia Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly
city: Torokbalint
country: Hungary
facility: Pest Megyei Tudogyogyintezet, III. Osztaly
city: Dublin
country: Ireland
facility: Aseptic Compounding Unit
city: Dublin
country: Ireland
facility: Department of Medical Oncology
city: Galway
country: Ireland
facility: Department of Medical Oncology
city: Galway
country: Ireland
facility: Merlin Park Imaging Centre
city: Galway
country: Ireland
facility: Pharmacy Aseptic Services Unit
city: Avellino
country: Italy
facility: Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera
city: Firenze
country: Italy
facility: S.C. Oncologia Medica
city: Genova
country: Italy
facility: Oncologia Medica A
city: Lido di Camaiore (LU)
country: Italy
facility: Ospedale Versilia, Oncologia Medica
city: Lucca
country: Italy
facility: Ospedale San Luca
city: Milano
country: Italy
facility: Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
city: Milano
country: Italy
facility: Farmacia Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk
city: Monza
country: Italy
facility: Nuovo Ospedale San Gerardo
city: Orbassano (TO)
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga
city: Perugia
country: Italy
facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
city: Roma
country: Italy
facility: Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani
city: Torino
country: Italy
facility: Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital
state: Aichi
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Osakasayama-shi
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center/Department of Thoracic Oncology
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center, Center for Lung Cancer
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan Univ School of Medicine
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Olsztyn
country: Poland
facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
city: Olsztyn
country: Poland
facility: Ars Medica
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej
city: Poznan
country: Poland
facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
city: Poznan
country: Poland
facility: Zaklad Diagnostyki Obrazowej
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic
city: Moscow
country: Russian Federation
facility: State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
city: Saint-Petersburg
country: Russian Federation
facility: Research Institute of Pulmonology
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Barcelona
city: L'hospitalet de Llobregat
country: Spain
facility: Institut Catala D'Oncologia - Hospital Duran I Reynals
state: Barcelona
city: Sabadell
country: Spain
facility: Consorcio Hospitalario Parc Tauli
state: Barcelona
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
state: Galicia
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D´Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Onkologiska kliniken
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Department of Internal Medicine
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Chest Department
city: Headington
country: United Kingdom
facility: Cancer and Haematology Centre,
state: Oxford
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Eastleigh
country: United Kingdom
facility: Nuffield Health Wessex Hospital
city: London
country: United Kingdom
facility: Department of Oncology
city: London
country: United Kingdom
facility: Kings College London at Guy's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust, Department of Medical Oncology
city: Southampton
country: United Kingdom
facility: Somers Cancer Research Building, M824
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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citation: Blackhall F, Ross Camidge D, Shaw AT, Soria JC, Solomon BJ, Mok T, Hirsh V, Janne PA, Shi Y, Yang PC, Pas T, Hida T, Carpeno JC, Lanzalone S, Polli A, Iyer S, Reisman A, Wilner KD, Kim DW. Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer. ESMO Open. 2017 Aug 17;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. eCollection 2017.
citation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.
citation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.
citation: Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crino L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.
citation: Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.
citation: Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.