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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: PF-02341066

• Study Type: Interventional
• Enrollment (Actual): 1069
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital, Department of Medical Oncology
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Department of Medical Oncology
• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40170-110
      • Nucleo de Oncologia da Bahia
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20231-050
      • Instituto Nacional do Cancer - INCA
  • RS
    • Ijui, RS, Brazil, 98700-000
      • Associacao Hospital de Caridade de Ijui
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
    • Porto Alegre, RS, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • SP
    • Barretos, SP, Brazil, 14784-400
      • Fundacao Pio Xii Hospital de Cancer de Barretos
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
    • Sao Paulo, SP, Brazil, 01509-900
      • Fundacao Antonio Prudente
  • Sao Paulo
    • Jau, Sao Paulo, Brazil, 17210-120
      • Fundacao Hospital Amaral Carvalho
• Bulgaria
  • Sofia, Bulgaria, 1606
    • MBAL Voennomeditsinska Academia, MMA HAT Sofia
  • Sofia, Bulgaria, 1756
    • Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Yoanna - ISUL
  • Varna, Bulgaria, 9002
    • MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
    • Calgary, Alberta, Canada, T2S 3C3
      • Alberta Health Services, Holy Cross Site
    • Calgary, Alberta, Canada, T2V 2C4
      • Office of Dr. John McWhae
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Dr. Leon Richard Oncology Centre
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr. Georges-L. Dumont Regional Hospital
  • Ontario
    • Oshawa, Ontario, Canada, L1J 8N8
      • Dr. Dana Blakolmer and Associates
    • Oshawa, Ontario, Canada, L1G 2B9
      • RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
    • Montreal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Center
    • Montreal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospsital
• China
  • Beijing, China, 100071
    • 307 Hospital of PLA
  • Beijing, China, 100021
    • Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department
  • Guangzhou, China, 510080
    • Guangdong General Hospital
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital
  • Shanghai, China, 200030
    • Shanghai Chest Hospital/Department of Pulmonary Medicine
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University / Respiratory Department
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing Bayi Hospital
• France
  • Caen Cedex 05, France, 14076
    • Centre François Baclesse
  • Dijon, France, 21079
    • Centre Georges-François Leclerc
  • Grenoble Cedex 09, France, 38043
    • Hôpital Albert Michallon
  • Marseille Cedex 20, France, 13915
    • APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
  • NICE Cedex 2, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75014
    • Hospital Cochin
  • Paris cedex 20, France, 75970
    • Hôpital Tenon
  • St Herblain Cedex, France, 44805
    • Centre Rene Gauducheau / Service d'Oncologie Medicale
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl-Gustav-Carus Dresden
  • Essen, Germany, 45122
    • Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung
  • Grosshansdorf, Germany, 22927
    • Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie
  • Hamburg, Germany, 22527
    • Ambulantes Krebszentrum Hamburg
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Koeln, Germany, 50937
    • Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
  • Muenchen, Germany, 80336
    • Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
  • Wiesbaden, Germany, 65199
    • HSK Dr.- Horst-Schmidt-Kliniken
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens "Sotiria"
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion/ Department of Clinical Oncology
  • Thessaloniki
    • Exohi, Thessaloniki, Greece, 57010
      • General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department
• Hong Kong
  • Pokfulam, Hong Kong
    • Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital
  • Shatin, New Territories, Hong Kong
    • Department of Clinical Oncology, Prince of Wales Hospital
  • Tuen Mun, New Territories, Hong Kong
    • Tuen Mun Hospital, Department of Clinical Oncology
• Hungary
  • Budapest, Hungary, 1121
    • Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem Pulmonologia Intezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Onkormanyzat Tudogyogyintezete
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly
  • Torokbalint, Hungary, 2045
    • Pest Megyei Tudogyogyintezet, III. Osztaly
• Ireland
  • Dublin, Ireland, 8
    • Aseptic Compounding Unit
  • Dublin, Ireland, Dublin 8
    • Department of Medical Oncology
  • Galway, Ireland
    • Department of Medical Oncology
  • Galway, Ireland
    • Merlin Park Imaging Centre
  • Galway, Ireland
    • Pharmacy Aseptic Services Unit
• Italy
  • Avellino, Italy, 83100
    • Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera
  • Firenze, Italy, 50134
    • S.C. Oncologia Medica
  • Genova, Italy, 16132
    • Oncologia Medica A
  • Lido di Camaiore (LU), Italy, 55043
    • Ospedale Versilia, Oncologia Medica
  • Lucca, Italy, 55100
    • Ospedale San Luca
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia
  • Milano, Italy, 20132
    • Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
  • Milano, Italy, 20162
    • Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk
  • Milano, Italy, 20141
    • Farmacia Istituto Europeo di Oncologia
  • Monza, Italy, 20900
    • Nuovo Ospedale San Gerardo
  • Orbassano (TO), Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Perugia, Italy, 06156
    • SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
  • Roma, Italy, 00152
    • Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani
  • Torino, Italy, 10126
    • Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette
• Japan
  • Fukuoka, Japan, 811-1395
    • National Kyushu Cancer Center/Department of Thoracic Oncology
  • Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi cancer center central hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kinki University Hospital
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 410-769
    • National Cancer Center, Center for Lung Cancer
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital / Department of Internal Medicine
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center, Sungkyunkwan Univ School of Medicine
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Olsztyn, Poland, 10-357
    • Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc
  • Olsztyn, Poland, 10-344
    • Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
  • Olsztyn, Poland, 10-357
    • ARS Médica
  • Olsztyn, Poland, 10-561
    • Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej
  • Poznan, Poland, 60-569
    • Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
  • Poznan, Poland, 60-569
    • Zaklad Diagnostyki Obrazowej
• Russian Federation
  • Kazan, Russian Federation, 420029
    • Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic
  • Moscow, Russian Federation, 115478
    • State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"
  • Saint-Petersburg, Russian Federation, 197022
    • Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
  • Saint-Petersburg, Russian Federation, 198255
    • City Clinical Oncology Dispensary
  • Saint-Petersburg, Russian Federation, 197089
    • Research Institute of Pulmonology
  • St. Petersburg, Russian Federation, 197022
    • City Clinical Oncology Dispensary
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Hospital General Universitari Vall D´Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Pamplona, Spain, 31008
    • Hospital De Navarra
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
    • L'hospitalet de Llobregat, Barcelona, Spain, 08907
      • Institut Català d'Oncologia - Hospital Duran i Reynals
    • Sabadell, Barcelona, Spain, 08208
      • Consorcio Hospitalario Parc Tauli
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complexo Hospitalario Universitario A Coruña
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Onkologiska kliniken
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital, Department of Internal Medicine
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital, Chest Department
• United Kingdom
  • Eastleigh, United Kingdom, SO53 2DW
    • Nuffield Health Wessex Hospital
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • London, United Kingdom, SE1 9RT
    • Kings College London at Guy's Hospital
  • London, United Kingdom, NW3 2QG
    • Department of Oncology
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital NHS Trust, Department of Medical Oncology
  • Southampton, United Kingdom, SO16 6YD
    • Somers Cancer Research Building, M824
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LJ
      • Cancer and Haematology Centre,
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • Beverly Hills, California, United States, 90211-1850
      • Tower Cancer Research Foundation
    • Beverly Hills, California, United States, 90211-1850
      • Tower Hematology Oncology Medical Group
    • La Jolla, California, United States, 92037
      • Moores UCSD Cancer Center
    • La Jolla, California, United States, 92093-0698
      • UCSD Medical Center - La Jolla
    • Los Angeles, California, United States, 90095
      • University of California-Los Angeles
    • Los Angeles, California, United States, 90095-6984
      • Drug Shipping Address: Ronald Reagen University of California-Los Angeles
    • Los Angeles, California, United States, 90095
      • Ronald Reagen University of California-Los Angeles Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Opthalmic Oncology Center
    • Orange, California, United States, 92868-3298
      • University of California, Irvine-Medical Center
    • Orange, California, United States, 92868-3298
      • University of California, Irvine-Pharmacy
    • Palo Alto, California, United States, 94305
      • Stanford University-Cancer Center
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Cancer Center
    • San Diego, California, United States, 92103
      • UCSD Medical Center - Hillcrest
    • Santa Monica, California, United States, 90404
      • UCLA Hematology Oncology-Santa Monica
    • Santa Monica, California, United States, 90404
      • University of California-Los Angeles
    • Santa Monica, California, United States, 90404
      • Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory
    • Santa Rosa, California, United States, 95403
      • Redwood Regional Medical Group Inc
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Lions Eye Institute
    • Aurora, Colorado, United States, 80045
      • DRUG SHIPMENT: University of Colorado Cancer Center
    • Denver, Colorado, United States, 80205
      • Kaiser Permanente Colorado - Franklin
    • Lafayette, Colorado, United States, 80026
      • Kaiser Permanente Colorado - Rock Creek
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale New Haven
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Center at Yale New Haven, Oncology Pharmacy
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Michael and Dianne Bienes Cancer Center, Holy Cross Hospital
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute
    • Lake Worth, Florida, United States, 33461
      • Cancer Center of South Florida Foundation, Inc.
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Center (West)
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center & Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Emory University Clinic
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institution
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialists - Administrative Annex
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Augusta, Georgia, United States, 30912
      • MCG Health Cancer Center Pharmacy
    • Augusta, Georgia, United States, 30912
      • MCG Health System Pharmacy (Drug Shipment Only)
    • Decatur, Georgia, United States, 30033
      • Georgia Cancer Specialists-Stemmer
    • Macon, Georgia, United States, 31217
      • Georgia Cancer Specialists-Macon
    • Marietta, Georgia, United States, 30060
      • Georgia Cancer Specialists-Kennestone
    • Sandy Springs, Georgia, United States, 30342
      • Georgia Cancer Specialists-Northside
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • OnCare Hawaii, Inc.
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Medical Center East
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii - Cancer Research Center of Hawaii
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center (Attn: J Pi PharmD / A. Patel Pharm D)
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital (Drug Shipment Only)
    • Harvey, Illinois, United States, 60426
      • Monroe Medical Associates
    • Tinley Park, Illinois, United States, 60477
      • Monroe Medical Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Ship drug to: Investigational Drug Services
    • Indianapolis, Indiana, United States, 46202
      • Wishard Memorial Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital Clarian Health
    • Indianopolis, Indiana, United States, 46290
      • Springmill Medical Clinic
    • Munster, Indiana, United States, 46321
      • The Community Hospital
    • Munster, Indiana, United States, 46321
      • Monroe Medical Associates
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Baltimore, Maryland, United States, 21231
      • The Harry and Jeanette Cancer Research Building
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health National Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute/Pharmacy
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Beth Isreal Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachussetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusette General Hospital
    • Boston, Massachusetts, United States, 02115
      • Beth Isreal Deaconess Medical Center, Pharmacy FD B18
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer lnstitute at Farmington Hllls
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St. Louis, Missouri, United States, 63110-1094
      • Barnes-Jewish Hospital
    • St. Peters, Missouri, United States, 63376
      • Siteman Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • University of Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
      • Dartmouth Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Cancer Center
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Eye Clinic
  • New York
    • Lake Success, New York, United States, 11042
      • NSLIJ Health System/Monter Cancer Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10022
      • Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion
    • New York, New York, United States, 10032
      • IP Shipment: CUMC Research Pharmacy
    • New York, New York, United States, 10065
      • Memorial Sloan - Kettering Cancer Center
    • Oneida, New York, United States, 13421
      • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
    • Oswego, New York, United States, 13126
      • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
    • Syracuse, New York, United States, 13210
      • Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
    • Syracuse, New York, United States, 13210-2306
      • SUNY Upstate Medical University, Regional Oncology Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Health Care
    • Chapel Hill, North Carolina, United States, 27599-7600
      • UNC Hospitals, The University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital Cancer Center
    • Huntersville, North Carolina, United States, 28078
      • Southern Oncology Specialists
    • Huntersville, North Carolina, United States, 28078
      • Presbyterian Hospital Huntersville
    • Matthews, North Carolina, United States, 28105
      • Presbyterian Hospital Matthews
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Investigational Drug Services
    • Columbus, Ohio, United States, 43205
      • The Ohio State University Hospital East
    • Columbus, Ohio, United States, 43210
      • The Ohio State University James Cancer Hospital and Solove Research Institute
    • Columbus, Ohio, United States, 43221
      • James Care in Kenny
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Pharma Resource
    • East Providence, Rhode Island, United States, 02914
      • Vincent Armenio, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina - Hollings Cancer Center
  • Tennessee
    • Dickson, Tennessee, United States, 37055
      • Tennessee Oncology, PLLC
    • Franklin, Tennessee, United States, 37067
      • Tennessee Oncology, PLLC
    • Gallatin, Tennessee, United States, 37066
      • Tennessee Oncology, PLLC
    • Hermitage, Tennessee, United States, 37076
      • Tennessee Oncology, PLLC
    • Lebanon, Tennessee, United States, 37087
      • Tennessee Oncology, PLLC
    • Murfreesboro, Tennessee, United States, 37130
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37205
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37207
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37211
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute (Pharmacy)
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute (Administration)
    • Nashville, Tennessee, United States, 37232-5536
      • Vanderbilt Cancer Clinic
    • Nashville, Tennessee, United States, 37232-7610
      • The Vanderbilt Chemo Clinic
    • Smyrna, Tennessee, United States, 37167
      • Tennessee Oncology, PLLC
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center at Dallas
    • Dallas, Texas, United States, 75390-9015
      • UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern University Hospital - Zale Lipshy
    • Dallas, Texas, United States, 75390
      • UT Southwestern University Hospital - William P. Clements, Jr
    • Houston, Texas, United States, 77030
      • The University of Texas
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Seattle, Washington, United States, 98122
      • Lisa Nakatsu, RPh (Drug Shipment Address)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-0231066	Drug: PF-02341066; PF-02341066, 250 mg BID, will be administered orally on a continuous schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.	6 years
Percentage of Participants With Adverse Events	Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DR)	DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4.	6 years
Time to Tumor Response (TTR)	TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.	6 years
Disease Control Rate (DCR)	DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.	6 years
Progression Free Survival (PFS)	PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.	6 years
Overall Survival (OS)	OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4.	6 years
Probability of Survival	Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.	6 years
Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182	Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.	6 years
Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)	Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.	6 years
Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)	The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.	6 years
QTc Prolongation in Participants	The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.	6 years
Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.	The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.	6 years
Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores	The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.	6 years
Mean Change From Baseline of QLQ-LC13 Scale Scores	The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.	6 years
Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)	The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.	6 years
Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale	The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.	6 years

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 30, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Lung Neoplasms ALK gene Crizotinib
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Crizotinib
• Other Study ID Numbers: A8081005; 2009-012504-13 (EudraCT Number)