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
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
2 other identifiers
interventional
347
22 countries
264
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2009
Longer than P75 for phase_3
264 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedResults Posted
Study results publicly available
June 6, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 2, 2017
October 1, 2016
2.5 years
June 30, 2009
March 13, 2013
October 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
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 (14)
Overall Survival (OS)
Randomization until death (up to 4.5 years)
Overall Survival Probability at Months 6 and 12
Month 6, 12
Percentage of Participants With Objective Response (OR)
Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
Percentage of Participants With Disease Control at Week 6
Week 6
Percentage of Participants With Disease Control at Week 12
Week 12
- +9 more secondary outcomes
Study Arms (2)
PF-02341066
EXPERIMENTALPemetrexed or Docetaxel
ACTIVE COMPARATORInvestigator selection of either pemetrexed or docetaxel as the active comparator
Interventions
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prior treatment with PF-02341066
- current treatment in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (264)
University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute
Little Rock, Arkansas, 72205, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
UCSD Medical Center -La Jolla
La Jolla, California, 92037, United States
Moores UC San Diego Cancer Center
La Jolla, California, 92093-0698, United States
Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA
Los Angeles, California, 90095-6984, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Hematology Oncology
Los Angeles, California, 90095, United States
UCLA Ophthalmic Oncology Center
Los Angeles, California, 90095, United States
University of California-Los Angeles
Los Angeles, California, 90095, United States
Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy
Orange, California, 92868-3298, United States
University of California, Irvine-Medical Center
Orange, California, 92868-3298, United States
Stanford University-Cancer Center
Palo Alto, California, 94305, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
UCSD Medical Center- Hillcrest
San Diego, California, 92103, United States
Santa Monica-UCLA Medical Center and Orthopaedic Hospital
Santa Monica, California, 90404, United States
University of California, Los Angeles
Santa Monica, California, 90404, United States
Redwood Regional Medical Group, Inc.
Santa Rosa, California, 95403, United States
Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Denver (CTRC)
Aurora, Colorado, 80045, United States
Unviersity of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion
Aurora, Colorado, 80045, United States
Kaiser Permanente
Denver, Colorado, 80205, United States
Kaiser Permanente
Lafayette, Colorado, 80026, United States
Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Clinical Trial Office
New Haven, Connecticut, 06519, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Cancer Center of South Florida Foundation, Inc.
Lake Worth, Florida, 33461, United States
Memorial Cancer Institute (West)
Pembroke Pines, Florida, 33028, United States
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Clinic
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Winship Cancer Institution
Atlanta, Georgia, 30322, United States
Georgia Cancer Specialists-Administrative Annex
Atlanta, Georgia, 30341, United States
Georgia Cancer Specialists - Stemmer
Decatur, Georgia, 30033, United States
Georgia Cancer Specialists-Macon
Macon, Georgia, 31217, United States
Georgia Cancer Specialists-Kennestone
Marietta, Georgia, 30060, United States
Georgia Cancer Specialists
Sandy Springs, Georgia, 30342, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center East
Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Inc.
Honolulu, Hawaii, 96813, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Ingalls Memorial Hospital (Drug Shipment Only)
Harvey, Illinois, 60426, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Monroe Medical Associates
Harvey, Illinois, 60426, United States
Monroe Medical Associates
Tinley Park, Illinois, 60477, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Ship Drug to: Investigational Drug Services
Indianapolis, Indiana, 46202, United States
Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Springmill Medical Clinic
Indianapolis, Indiana, 46290, United States
Monroe Medical Associates
Munster, Indiana, 46321, United States
The Community Hospital
Munster, Indiana, 46321, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
Massachusette General Hospital
Boston, Massachusetts, 02114, United States
Massachussetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
DFCI/Pharmacy (Drug Shipment Only)
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Siteman Cancer Center
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center- West County
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1094, United States
Washington University, School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
NSLIJ Health System/Monter Cancer Center
Lake Success, New York, 11042, United States
Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion
New York, New York, 10022, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Oneida, New York, 13421, United States
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Oswego, New York, 13126, United States
SUNY Upstate Medical University
Syracuse, New York, 13210-2306, United States
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Syracuse, New York, 13210, United States
Investigational Drug Service, Pharmacy Department, UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals
Chapel Hill, North Carolina, 27599-7600, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Hospital East
Columbus, Ohio, 43205, United States
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
James Care in Kenny
Columbus, Ohio, 43221, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033-0850, United States
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center-Shadyside
Pittsburgh, Pennsylvania, 15232, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Vincent Armenio, MD
East Providence, Rhode Island, 02914, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37130, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203 (Pharmacy), United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
The Vanderbilt Cancer Clinic
Nashville, Tennessee, 37232-5536, United States
The Vanderbilt Chemo Pharmacy
Nashville, Tennessee, 37232-7610, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
The University of Texas
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Investigational Drug Service
Seattle, Washington, 98122, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Sydney Cancer Centre
Camperdown, New South Wales, 2050, Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
East Melbourne, Victoria, 3002, Australia
Department of Medical Oncology
Nedlands, Western Australia, 6009, Australia
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil
Associacao Hospital de Caridade de Ijui
IjuĂ, Rio Grande do Sul, 98700-000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, SĂŁo Paulo, 14784-400, Brazil
Fundacao Hospital Amaral Carvalho
JaĂş, SĂŁo Paulo, 17210-120, Brazil
Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP
SĂŁo Paulo, SĂŁo Paulo, 01246-000, Brazil
Fundacao Antonio Prudente
SĂŁo Paulo, SĂŁo Paulo, 01509-900, Brazil
UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya
Sofia, Bulgaria, 1527, Bulgaria
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
Sofia, Bulgaria, 1756, Bulgaria
MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie
Plovdiv, 4004, Bulgaria
MBAL Voennomeditsinska Academia, MMA HAT Sofia
Sofia, 1606, Bulgaria
MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
Varna, 9002, Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Alberta Health Services, Holy Cross Site
Calgary, Alberta, T2S 3C3, Canada
Office of Dr. John McWhae
Calgary, Alberta, T2V 2C4, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Dr. Georges-L. Dumont Regional Hospital
Moncton, New Brunswick, E1C 2Z3, Canada
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
RSM Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
Dr. Dana Blakolmer and Associates
Oshawa, Ontario, L1J 8N8, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5, Canada
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC
Beijing, 100021, China
307 Hospital of PLA
Beijing, 100071, China
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, 200030, China
Shanghai Chest Hospital
Shanghai, 200030, China
Zhongshan Hospital Fudan University / Respiratory Department
Shanghai, 200032, China
Shanghai Pulmonary Hospital/Dept. of Oncology
Shanghai, 200433, China
Centre Francois Baclesse
Caen, 14076, France
Centre Georges-François Leclerc
Dijon, 21079, France
Hopital Albert Michallon
Grenoble, 38043, France
Pr Fabrice BARLESI
Marseille, 13915, France
Centre Antoine Lacassagne
Nice, 06189, France
Groupe Hospitalier Cochin
Paris, 75679, France
Hopital Tenon / Service de Pneumologie
Paris, 75970, France
Centre Rene Gauducheau / Service d'Oncologie Medicale
Saint-Herblain, 44805, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
Cologne, 50937, Germany
Universitaetsklinik Carl-Gustav-Carus Dresden
Dresden, 01307, Germany
Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung
Essen, 45122, Germany
Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie
GroĂźhansdorf, 22927, Germany
MVZ Prof. Mathey, Pfrof. Schofer GmbH
Hamburg, 22527, Germany
Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren
Heidelberg, 69126, Germany
Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie
MĂĽnchen, 80336, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin
Wiesbaden, 65199, Germany
University General Hospital of Heraklion/ Department of Clinical Oncology
Heraklion, Crete, 71110, Greece
General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department
Eksochi, Thessaloniki, 57010, Greece
General Hospital of Chest Diseases of Athens "Sotiria"
Athens, 11527, Greece
Tuen Mun Hospital, Department of Clinical Oncology
Tuenmen, New Territories, Hong Kong
Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital
Pokfulam, Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Orszagos Koranyi TBC Ă©s Pulmonologiai Intezet, VI. Bronchologia
Budapest, 1121, Hungary
Semmelweis Egyetem Pulmonologia Intezet
Budapest, 1125, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika
Debrecen, 4032, Hungary
Veszprem Megyei Onkormanyzat Tudogyogyintezete
Farkasgyepű, 8582, Hungary
Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly
Székesfehérvár, 8000, Hungary
Pest Megyei Tudogyogyintezet, III. Osztaly
Törökbálint, 2045, Hungary
Aseptic Compounding Unit
Dublin, Ireland
Department of Medical Oncology
Dublin, Ireland
Department of Medical Oncology
Galway, Ireland
Merlin Park Imaging Centre
Galway, Ireland
Pharmacy Aseptic Service Unit
Galway, Ireland
A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati
Avellino, 83100, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
Oncologia Medica A
Genova, 16132, Italy
Ospedale Versilia, Oncologia Medica
Lido Di Camaiore (LU), 55043, Italy
Ospedale San Luca
Lucca, 55100, Italy
Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
Milan, 20132, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk
Milan, 20162, Italy
Nuovo Ospedale San Gerardo
Monza, 20052, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), 10043, Italy
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
Perugia, 06132, Italy
Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani
Roma, 00152, Italy
Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette
Torino, 10126, Italy
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Akashi, HyĹŤgo, 673-8558, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kinki University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
Olsztyn, NAP, 10-344, Poland
Centrum Medyczne Ars Medica
Olsztyn, NAP, 10-357, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, NAP, 10-561, Poland
Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.
Otwock, Poland, 05-400, Poland
Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, 10-357, Poland
Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, 05-400, Poland
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, 60-569, Poland
Zaklad Diagnostyki Obrazowej
Poznan, 60-569, Poland
Lux Med. Sp.z o.o
Warsaw, 02-676, Poland
Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic
Kazan', 420029, Russia
State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"
Moscow, 115478, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
Saint Petersburg, 197022, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Research Institute of Pulmonology
Saint-Peterburg, 197089, Russia
State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region
Sochi, 354057, Russia
National Cancer Center, Center for Lung Cancer
Goyang-si, Gyeonggi-do, 410-769, South Korea
Seoul National University Hospital / Department of Internal Medicine
Seoul, 110-744, South Korea
Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
Seoul, 135-710, South Korea
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)
A Coruña, A Coruña, 15006, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Hospital Del Mar
Barcelona, Barcelona, 08003, Spain
Hospital General Universitari Vall D´Hebron
Barcelona, Barcelona, 08035, Spain
Institut Catala Doncologia - Hospital Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Consorcio Hospitalario Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Universitario Virgen Del Rocio
Seville, Sevilla, 41013, Spain
Karolinska Universitetssjukhuset, Onkologiska kliniken
Stockholm, 171 76, Sweden
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital, Department of Internal Medicine
Taipei, 100, Taiwan
Taipei Veterans General Hospital, Chest Department
Taipei, 112, Taiwan
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
The Alexandra Hospital
Cheshire, SK8 2PX, United Kingdom
Nuffield Health Wessex Hospital
Eastleigh, SO53 2DW, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Kings College London at Guy's Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Christie Hospital NHS Trust, Department of Medical Oncology
Manchester, M20 4BX, United Kingdom
Cancer and Haematology Centre,
Oxford, OX3 7LJ, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD, United Kingdom
Related Publications (8)
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.
PMID: 30822515DERIVEDWilner 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.
PMID: 30652510DERIVEDYoneda 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.
PMID: 28373069DERIVEDLin 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.
PMID: 27130468DERIVEDCosta 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.
PMID: 25624436DERIVEDLin 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.
PMID: 25436806DERIVEDShaw 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.
PMID: 23724913DERIVEDTamiya 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.
PMID: 23169500DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No analyses of ALK fusion variants or protein expression were done due to limited slide stability of unstained tissue sections required for immunohistochemistry and no nucleic acid based assay was available to identify specific ALK gene fusion.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 3, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2012
Study Completion
January 1, 2016
Last Updated
January 2, 2017
Results First Posted
June 6, 2013
Record last verified: 2016-10