Clinical trial NCT00932893: An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Official title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung Neoplasms ALK gene crizotinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically proven diagnosis of non-small cell lung cancer
* positive for the ALK fusion gene (test provided by a central laboratory)
* must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
* tumors must be measurable

Exclusion Criteria:

* prior treatment with PF-02341066
* current treatment in another clinical trial

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization until death (up to 4.5 years)
measure: Overall Survival Probability at Months 6 and 12
timeFrame: Month 6, 12
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
measure: Percentage of Participants With Disease Control at Week 6
timeFrame: Week 6
measure: Percentage of Participants With Disease Control at Week 12
timeFrame: Week 12
measure: Duration of Response (DR)
timeFrame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
measure: Time to Tumor Response (TTR)
timeFrame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
measure: Plasma Concentration of Crizotinib
timeFrame: Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5
measure: Number of Participants With Categorical Maximum QTcF for Crizotinib
timeFrame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2
measure: Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins
timeFrame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)
measure: Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough
timeFrame: Baseline up to end of treatment (up to 112 weeks)
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)
timeFrame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
measure: European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute
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: UCSD Medical Center -La Jolla
state: California
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: Los Angeles
country: United States
facility: Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA Ophthalmic Oncology Center
state: California
city: Los Angeles
country: United States
facility: University of California-Los Angeles
state: California
city: Orange
country: United States
facility: Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy
state: California
city: Orange
country: United States
facility: University of California, Irvine-Medical Center
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 and Orthopaedic Hospital
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, Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver (CTRC)
state: Colorado
city: Aurora
country: United States
facility: Unviersity of Colorado Hospital, Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente
state: Colorado
city: New Haven
country: United States
facility: Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP
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: Clinical Trial Office
state: Connecticut
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
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 Institute (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: 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
state: Georgia
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Medical Center East
state: Hawaii
city: Honolulu
country: United States
facility: OnCare Hawaii, Inc.
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
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
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: Indianapolis
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: 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: 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
state: Massachusetts
city: Boston
country: United States
facility: DFCI/Pharmacy (Drug Shipment Only)
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Lawrence and Idell Weisberg Cancer Treatment Center
state: Michigan
city: Creve Coeur
country: United States
facility: Siteman Cancer Center- West County
state: Missouri
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: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Lake Success
country: United States
facility: NSLIJ Health System/Monter Cancer 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: 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
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: Investigational Drug Service, Pharmacy Department, UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals
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 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 at Perelman Center for Advanced Medicine
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-Shadyside
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: 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
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
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: The Vanderbilt Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: The Vanderbilt Chemo Pharmacy
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
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: Investigational Drug Service
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: Sydney Cancer Centre
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: BA
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de 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 de São Paulo "Octavio Frias de Oliveira" - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente
state: SP
city: Plovdiv
country: Bulgaria
facility: MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie
city: Sofia
country: Bulgaria
facility: UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya
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
state: Ontario
city: Oshawa
country: Canada
facility: Dr. Dana Blakolmer and Associates
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
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 Hospital
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: Guangzhou
country: China
facility: Guangdong General Hospital
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
city: Beijing
country: China
facility: 307 Hospital of PLA
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/Dept. of Oncology
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse
city: DIJON Cedex
country: France
facility: Centre Georges-François Leclerc
city: Grenoble Cedex 09
country: France
facility: Hopital Albert Michallon
city: Marseille Cedex 20
country: France
facility: Pr Fabrice BARLESI
city: NICE Cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris Cedex 14
country: France
facility: Groupe Hospitalier Cochin
city: Paris cedex 20
country: France
facility: Hopital Tenon / Service de Pneumologie
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: Universitaetsklinik 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: MVZ Prof. Mathey, Pfrof. Schofer GmbH
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren
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, Innere Medizin III Haematologie, Onkologie, Palliativmedizin
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: Tuen Mun
country: Hong Kong
facility: Tuen Mun Hospital, Department of Clinical Oncology
state: New Territories
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: Budapest
country: Hungary
facility: Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Pulmonologia Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi 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 8
country: Ireland
facility: Aseptic Compounding Unit
city: Dublin 8
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 Service Unit
city: Avellino
country: Italy
facility: A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
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: Istituto Europeo di Oncologia IRCCS
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: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Okayama-city
country: Japan
facility: Okayama University Hospital
state: Okayama
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
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Center for Lung Cancer
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Olsztyn
country: Poland
facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
state: NAP
city: Olsztyn
country: Poland
facility: Centrum Medyczne Ars Medica
state: NAP
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
state: NAP
city: Gdansk
country: Poland
facility: Klinika Onkologii i Radioterapii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
city: Otwock
country: Poland
facility: Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Otwock
country: Poland
facility: Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.
city: Poznan
country: Poland
facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
city: Poznan
country: Poland
facility: Zaklad Diagnostyki Obrazowej
city: Warszawa
country: Poland
facility: Lux Med. Sp.z o.o
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-Peterburg
country: Russian Federation
facility: Research Institute of Pulmonology
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
city: Sochi
country: Russian Federation
facility: State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region
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 Doncologia - Hospital Duran I Reynals
state: Barcelona
city: Sabadell
country: Spain
facility: Consorcio Hospitalario Parc Tauli
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)
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: 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: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Cheshire
country: United Kingdom
facility: The Alexandra Hospital
city: Eastleigh
country: United Kingdom
facility: Nuffield Health Wessex Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
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: Oxford
country: United Kingdom
facility: Cancer and Haematology Centre,
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.
citation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.
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: Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Janne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1.
citation: Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19. No abstract available.