A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014)

September 29, 2017 updated by: Pfizer

Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
      • Douglas, Queensland, Australia, 4814
        • The Townsville Hospital
      • Herston, Queensland, Australia, 4006
        • The Royal Brisbane & Womens Hospital
      • Hyde Park, Queensland, Australia, 4812
        • Parkhaven Medical Center
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Department of Medical Oncology
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology
      • Frankston, Victoria, Australia, 3199
        • Peninsula & South Eastern Haematology and Oncology Group
  • Austria
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • Belgium
      • Brussel, Belgium, 1090
        • Universitair Ziekenhuis Brussel / Medische Oncologie
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St Luc
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet, Centre des Tumeurs de l'ULB
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent (U.Z. Gent)
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege
      • Roeselare, Belgium, 8800
        • Department of Pulmonary Diseases AZ Delta
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • UZ Antwerpen-Pneumologie
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hopital de Charleroi -Site Notre Dame
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20231 -050
        • Instituto Nacional de Câncer - INCA
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Associacao Hospital de Caridade de Ijui
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
    • SP
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Fundação Pio XII Hospital de Câncer de Barretos
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Centre
      • Halifax, Nova Scotia, Canada, B2H 2Y9
        • QEII Health Sciences Centre
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • R.S. McLaughlin Durham Regional Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Chile
    • Cautin
      • Temuco, Cautin, Chile, 4810469
        • Instituto Clinico Oncologico del Sur
    • RM
      • Santiago, RM, Chile, 8380455
        • Instituto Nacional del Cancer
    • Santiago, Rm
      • Independencia, Santiago, Rm, Chile, 8380456
        • Hospital Clinico Universidad de Chile, Seccion de Oncologia
  • China
      • Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Shanghai, China, 200030
        • Shanghai Chest Hospital/Department of Pulmonary Medicine
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital/Dept. of Oncology
      • Shanghai, China, 200030
        • Zhongshan Hospital Fudan University
    • Beijing
      • Beijing, Beijing, China, 100071
        • 307 Hospital of PLA
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Oncology Center, Guangdong General Hospital
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • No.81 Hospital of the PLA
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Oncology Department, West China Hospital of Sichuan University
  • Finland
      • Helsinki, Finland, 00290
        • Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka
      • Pori, Finland, 28500
        • Satakunnan keskussairaala/Keuhkosairauksien osasto A4
      • Tampere, Finland, 33520
        • Tampereen yliopistollinen sairaala
  • France
      • Bobigny Cedex, France, 93009
        • Hopital Avicenne
      • Caen Cedex, France, 14033
        • CHU de Caen
      • Grenoble Cedex, France, 38043
        • CHU Grenoble
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon Cedex 08, France, 69373
        • Centre Leon Berard
      • Marseille Cedex 20, France, 13915
        • APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve / CHU de Montpellier
      • Paris cedex 20, France, 75970
        • Hopital Tenon, Service de pneumologie
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Berlin, Germany, 10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Heidelberg, Germany, 69126
        • Thoraxklinik am Universitaetsklinikum Heidelberg
      • Karlsruhe, Germany, 76137
        • St.Vincentius-Kliniken Karlsruhe
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Moenchengladbach, Germany, 41063
        • Kliniken Maria Hilf GmbH
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
      • Wiesbaden, Germany, 65199
        • HSK Dr.- Horst-Schmidt-Kliniken GmbH,
  • Hong Kong
      • Kowloon, Hong Kong
        • Department of Clinical Oncology, Queen Elizabeth Hospital
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • India
    • Gujarat
      • Ahmedabad,, Gujarat, India, 380 016
        • The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Centre, Tata Memorial Hospital,
  • Ireland
      • Dublin, Ireland, Dublin 8
        • Department of Medical Oncology
      • Dublin, Ireland, Dublin 8
        • Aseptic Compounding Unit
  • Italy
      • Aviano (PN), Italy, 33081
        • Farmacia
      • Bari, Italy, 70124
        • Istituto dei tumori Giovanni Paolo II
      • Bologna, Italy, 40100
        • Unità Operativa di Oncologia Medica Azienda USL Città di Bologna
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero-Universitaria "Mater Domini"
      • Catanzaro, Italy, 88100
        • Unità Operativa di Farmacia - Campus Salvatore venuta
      • Livorno, Italy, 57124
        • Ospedale Civile Azienda USL Toscana Nord Ovest
      • Livorno, Italy, 57124
        • Unità Operativa Farmacia Ospedaliera PO di Livorno
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1
      • Milano, Italy, 20141
        • Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia
      • Milano, Italy, 20162
        • Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck
      • Napoli, Italy, 80131
        • A.O.R.N. Ospedale Dei Colli - Monaldi
      • Napoli, Italy, 80131
        • Farmacia
      • Orbassano (TO), Italy, 10043
        • Azienda Ospedaliera Universitaria San Luigi Gonzaga
      • Orbassano (TO), Italy, 10043
        • S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga
      • Parma, Italy, 43126
        • Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma
      • Perugia, Italy, 06132
        • Farmacia Ospedaliera
      • Perugia, Italy, 06132
        • SC Oncologia Medica, Ospedale Santa Maria della Misericordia
      • Reggio Emilia, Italy, 42123
        • IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia
      • Roma, Italy, 00144
        • Istituto Regina Elena, Struttura Complessa Oncologia Medica A
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani
      • Roma, Italy, 00152
        • Farmacia Interna
      • Roma, Italy, 00168
        • Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital Respiratory Medicine
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi cancer center central hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Cancer Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Okayama
      • Okayama-city, Okayama, Japan, 700-8558
        • Okayama University Hospital
    • 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
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-0241
        • National Hospital Organization Yamaguchi-Ube Medical Center
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • Centre Hospitalier de Luxembourg
  • Mexico
    • D.f.
      • Mexico, D.f., Mexico, 14080
        • Instituto Nacional De Cancerologia
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VUMC
      • Maastricht, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose
    • NB
      • 's Hertogenbosch, NB, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
  • Norway
      • Oslo, Norway, 0424
        • Oslo universitetssykehus HF - Radiumhospitalet
  • Peru
    • Lima
      • San Isidro, Lima, Peru, 27
        • Clinica Anglo Americana/Centro de Investigacion Oncologia CAA
  • Portugal
      • Coimbra, Portugal, 3041-801
        • Centro Hospitalar e Universitario de Coimbra - Hospital Geral
      • Lisboa, Portugal, 1099-023
        • Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.
      • Lisboa, Portugal, 1769-001
        • Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Oncological Research Center N.N. Blokhin
      • Saint-Petersburg, Russian Federation, 197022
        • City Clinical Oncology Dispensary
      • Saint-Petersburg, Russian Federation, 198255
        • City Clinical Oncology Dispensary
      • Saint-Petersburg, Russian Federation, 197758
        • Russian Scientific Center of Radiology and Surgical Technologies
      • Saint-Petersburg, Russian Federation, 197022
        • First Saint-Petersburg State Medical University n.a. I.P. Pavlov
      • Saint-Petersburg, Russian Federation, 197101
        • First Saint-Petersburg State Medical University n.a. I.P.
      • Samara, Russian Federation, 443031
        • Samara Regional Clinical Oncology Dispensary
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Singapore, 258499
        • Oncocare Cancer Centre
      • Singapore, Singapore, 228510
        • Parkway Cancer Centre
  • South Africa
      • Cape Town, South Africa, 7700
        • Rondebosch Oncology Centre, Rondebosch Medical Centre
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • University of Witwatersrand Oncology
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Doce de Octubre
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
        • Hospital Universitario Virgen Macarena
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
  • Switzerland
      • Basel, Switzerland, CH-4031
        • Universitaetsspital Basel
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital (LUKS)
      • Winterthur, Switzerland, CH-8401
        • Kantonsspital Winterthur
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Medical Foundation, Kaohsiung Branch
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital, Comprehensive Cancer Center
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation, Linkou Branch
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • City Multiple-Discipline Clinical Hospital #4,
      • Dnipropetrovsk, Ukraine, 49102
        • City Multiple-Discipline Clinical Hospital #4
      • Dnipropetrovsk, Ukraine, 49102
        • Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncologic Center/Department of Chemotherapy
      • Lviv, Ukraine, 79031
        • Lviv State Oncologic Regional Treatment and Diagnostic Center
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Manchester, United Kingdom, M20 4BX
        • The Christie Hospital NHS Foundation Trust, Department of Medical Oncology
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital, Oncology Centre
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
        • Lister Hospital
      • Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
        • Queen Elizabeth II Hospital
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M16 8AJ
        • Spire Manchester Hospital
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital, Mount Vernon Cancer Centre
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,
      • Glasgow, Scotland, United Kingdom, G52 3NQ
        • Ross Hall Hospital
  • United States
    • California
      • Beverly Hills, California, United States, 90211-1850
        • Tower Cancer Research Foundation
      • Beverly Hills, California, United States, 90211-1850
        • Tower Hematology Oncology Medical Group
      • Fontana, California, United States, 92335
        • CCTAP
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, United States, 92350
        • Loma Linda University Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion
      • Los Angeles, California, United States, 90027
        • CCTAP
      • San Diego, California, United States, 92108
        • Kaiser Permanente Southern California
      • San Diego, California, United States, 92120
        • CCTAP
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital
      • Washington, D.C., District of Columbia, United States, 20007
        • Research Pharmacy, Georgetown University Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute Center for Hematology Oncology
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Orlando, Florida, United States, 32804
        • Cancer Institute Of Florida
      • Orlando, Florida, United States, 32804
        • Investigational Drug Services
    • Georgia
      • Athens, Georgia, United States, 30606
        • Georgia Cancer Specialists
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists
      • Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists
      • Macon, Georgia, United States, 31217
        • Georgia Cancer Specialists
      • Marietta, Georgia, United States, 30060
        • Georgia Cancer Specialists
      • Sandy Springs, Georgia, United States, 30342
        • Georgia Cancer Specialists
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Harvey, Illinois, United States, 60426
        • Monroe Medical Associates
      • Harvey, Illinois, United States, 60426
        • Al Fisher, Pharm D.
      • 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
        • Indiana University Hospital
      • Indianapolis, Indiana, United States, 46202
        • Lois and Eskenazi Hospital
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Munster, Indiana, United States, 46321
        • Monroe Medical Association
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maine
      • Biddeford, Maine, United States, 04005
        • Maine Center For Cancer Medicine
      • Brunswick, Maine, United States, 04011
        • Maine Center For Cancer Medicine
      • Sanford, Maine, United States, 04073
        • Maine Center For Cancer Medicine
      • Scarborough, Maine, United States, 04074
        • Maine Center For Cancer Medicine
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Kresge Eye Institute
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute at Farmington Hills
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center - West County
      • Saint Louis, Missouri, United States, 63110-1094
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University Center for Advanced Medicine Infusion Center Pharmacy
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Hematology-Oncology Associates of Northern New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87106
        • UNM Eye Clinic
      • Las Cruces, New Mexico, United States, 88011
        • Memorial Medical Center
    • 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
      • Syracuse, New York, United States, 13210
        • Suny Upstate Medical University
    • Oregon
      • Beaverton, Oregon, United States, 97006
        • OHSU Knight Cancer Institute
      • Gresham, Oregon, United States, 97030
        • OHSU Knight Cancer Institute
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97210
        • OHSU Knight Cancer Institute
      • Portland, Oregon, United States, 97216
        • OHSU Knight Cancer Institute
      • Tualatin, Oregon, United States, 97062
        • OHSU Knight Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Pharma Resource
      • East Providence, Rhode Island, United States, 02914
        • Vincent Armenio
    • 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
        • Sarah Cannon Research Institute
      • 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, 37232-5536
        • Henry-Joyce Cancer Clinic
      • Nashville, Tennessee, United States, 37232-7610
        • Vanderbilt Oncology Pharmacy
      • Smyrna, Tennessee, United States, 37167
        • Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75390
        • UT Southwestern University Hospital - Zale Lipshy
      • Dallas, Texas, United States, 75390
        • UT Southwestern University Hospital - William P. Clements, Jr.
      • Dallas, Texas, United States, 75390-9015
        • UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5666
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  • Positive for translocation or inversion events involving the ALK gene locus
  • No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  • Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
  • 18 years of age or older with the exception of India which has an upper age limit of 65 years old

Exclusion Criteria:

  • Current treatment on another therapeutic clinical trial.
  • Prior therapy directly targeting ALK.
  • Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  • Pregnancy or breastfeeding.
  • Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  • Known HIV infection
  • Known interstitial lung disease or interstitial fibrosis
  • Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice
Experimental: A
Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) Based on IRR
Time Frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to death or last date known alive for those not known to have died (up to 72 months)
OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.
From randomization to death or last date known alive for those not known to have died (up to 72 months)
Overall Survival Probability at Month 12 and 18
Time Frame: Month 12, 18
Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.
Month 12, 18
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
Time Frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Duration of Response (DR) Based on IRR
Time Frame: From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions, disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Tumor Response (TTR) Based on IRR
Time Frame: Randomization to first documentation of objective tumor response (up to 35 months)
TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
Randomization to first documentation of objective tumor response (up to 35 months)
Percentage of Participants With Disease Control at Week 12 Based on IRR
Time Frame: Week 12
Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
Week 12
Time to Progression (TTP) Based on IRR
Time Frame: Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - randomization date +1)/30.44.
Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Intracranial Progression (IC-TTP) Based on IRR
Time Frame: Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Extracranial Progression (EC-TTP) Based on IRR
Time Frame: Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to follow up period (up to 72 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Baseline up to follow up period (up to 72 months)
Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to follow up period (up to 72 months)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Baseline up to follow up period (up to 72 months)
Percentage of Participants With Adverse Events (AEs) According to Maximum Severity
Time Frame: Baseline up to follow up period (up to 72 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.
Baseline up to follow up period (up to 72 months)
Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182
Time Frame: Predose at Day 1 of Cycle 2, 3 and 5
Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.
Predose at Day 1 of Cycle 2, 3 and 5
Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants
Time Frame: 28 days prior to day 1 of study treatment
The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.
28 days prior to day 1 of study treatment
Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR
Time Frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
The Response Genetics, Inc. EML4 ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants with confirmed CR or PR according to RECIST v1.1 determined by IRR, by type of ALK gene fusion variant were reported in this outcome measure. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough
Time Frame: From randomization of treatment up to deterioration while on study treatment (up to 35 months)
TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.
From randomization of treatment up to deterioration while on study treatment (up to 35 months)
Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)
Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)
Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)
Time Frame: Baseline up to follow up period (up to 72 months)
Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization and date of discharge.
Baseline up to follow up period (up to 72 months)
Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities
Time Frame: Baseline up to follow up period (up to 72 months)
Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.
Baseline up to follow up period (up to 72 months)
Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities
Time Frame: Baseline up to follow up period (up to 72 months)
ALT/AST (Grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Alkaline Phosphatase (g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160-250,g3:>250-500,g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40,g3:<40-30,g4:<30mg/dL);hyperkalemia (g1:>ULN-5.5,g2:>5.5-6,g3:>6-7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3-2.5,g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3-8,g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7,g3:<7-6,g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5,g3:>12.5-13.5,g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7,g4:<0.7mg/dL);hyponatremia (g1:<LLN-130,g3:<130-120,g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2,g3:<2,g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL). Participant>=1 abnormality given.
Baseline up to follow up period (up to 72 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2011

Primary Completion (Actual)

November 30, 2013

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (Estimate)

June 30, 2010

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8081014
  • 2010-021336-33 (EudraCT Number)
  • XALCORI (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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