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
2 other identifiers
interventional
1,069
22 countries
280
Brief Summary
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2010
Longer than P75 for phase_2
280 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
June 9, 2016
CompletedJanuary 13, 2017
November 1, 2016
5.2 years
June 30, 2009
March 14, 2016
November 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (15)
Duration of Response (DR)
6 years
Time to Tumor Response (TTR)
6 years
Disease Control Rate (DCR)
6 years
Progression Free Survival (PFS)
6 years
Overall Survival (OS)
6 years
- +10 more secondary outcomes
Study Arms (1)
PF-0231066
EXPERIMENTALInterventions
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
Eligibility Criteria
You may qualify if:
- histologically or cytologically proven diagnosis of non-small cell lung cancer
- positive for the ALK fusion gene (test provided by 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (280)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211-1850, United States
Moores UCSD Cancer Center
La Jolla, California, 92037, United States
UCSD Medical Center - La Jolla
La Jolla, California, 92093-0698, United States
Drug Shipping Address: Ronald Reagen University of California-Los Angeles
Los Angeles, California, 90095-6984, United States
Ronald Reagen University of California-Los Angeles Medical Center
Los Angeles, California, 90095, United States
UCLA Opthalmic Oncology Center
Los Angeles, California, 90095, United States
University of California-Los Angeles
Los Angeles, California, 90095, United States
University of California, Irvine-Medical Center
Orange, California, 92868-3298, United States
University of California, Irvine-Pharmacy
Orange, California, 92868-3298, United States
Stanford University-Cancer Center
Palo Alto, California, 94305, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
UCSD Medical Center - Hillcrest
San Diego, California, 92103, United States
Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory
Santa Monica, California, 90404, United States
UCLA Hematology Oncology-Santa Monica
Santa Monica, California, 90404, United States
University of California-Los Angeles
Santa Monica, California, 90404, United States
Redwood Regional Medical Group Inc
Santa Rosa, California, 95403, United States
DRUG SHIPMENT: University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Kaiser Permanente Colorado - Franklin
Denver, Colorado, 80205, United States
Kaiser Permanente Colorado - Rock Creek
Lafayette, Colorado, 80026, United States
Smilow Cancer Center at Yale New Haven, Oncology Pharmacy
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Michael and Dianne Bienes Cancer Center, Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Cancer Center of South Florida Foundation, Inc.
Lake Worth, Florida, 33461, United States
Memorial Cancer Center (West)
Pembroke Pines, Florida, 33028, United States
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Clinic
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Winship Cancer Institution
Atlanta, Georgia, 30322, United States
Georgia Cancer Specialists - Administrative Annex
Atlanta, Georgia, 30341, United States
MCG Health Cancer Center Pharmacy
Augusta, Georgia, 30912, United States
MCG Health System Pharmacy (Drug Shipment Only)
Augusta, Georgia, 30912, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Georgia Cancer Specialists-Stemmer
Decatur, Georgia, 30033, United States
Georgia Cancer Specialists-Macon
Macon, Georgia, 31217, United States
Georgia Cancer Specialists-Kennestone
Marietta, Georgia, 30060, United States
Georgia Cancer Specialists-Northside
Sandy Springs, Georgia, 30342, United States
OnCare Hawaii, Inc.
Honolulu, Hawaii, 96813, United States
University of Hawaii - Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center East
Honolulu, Hawaii, 96817, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center (Attn: J Pi PharmD / A. Patel Pharm D)
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Ingalls Memorial Hospital (Drug Shipment Only)
Harvey, Illinois, 60426, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Monroe Medical Associates
Harvey, Illinois, 60426, United States
Monroe Medical Associates
Tinley Park, Illinois, 60477, United States
Indiana University Hospital Clarian Health
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Ship drug to: Investigational Drug Services
Indianapolis, Indiana, 46202, United States
Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Springmill Medical Clinic
Indianopolis, Indiana, 46290, United States
Monroe Medical Associates
Munster, Indiana, 46321, United States
The Community Hospital
Munster, Indiana, 46321, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
The Harry and Jeanette Cancer Research Building
Baltimore, Maryland, 21231, United States
National Institutes of Health National Cancer Institute
Bethesda, Maryland, 20892, United States
Massachusette General Hospital
Boston, Massachusetts, 02114, United States
Massachussetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Isreal Deaconess Medical Center, Pharmacy FD B18
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute/Pharmacy
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer lnstitute at Farmington Hllls
Farmington Hills, Michigan, 48334, United States
Siteman Cancer Center
City of Saint Peters, Missouri, 63376, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1094, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Dartmouth Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 03756-0001, United States
University of New Mexico Eye Clinic
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131, United States
NSLIJ Health System/Monter Cancer Center
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion
New York, New York, 10022, United States
Columbia University Medical Center
New York, New York, 10032, United States
IP Shipment: CUMC Research Pharmacy
New York, New York, 10032, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, 10065, United States
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Oneida, New York, 13421, United States
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Oswego, New York, 13126, United States
SUNY Upstate Medical University, Regional Oncology Center
Syracuse, New York, 13210-2306, United States
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Syracuse, New York, 13210, United States
UNC Health Care
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600, United States
Presbyterian Hospital Cancer Center
Charlotte, North Carolina, 28204, United States
Presbyterian Hospital Huntersville
Huntersville, North Carolina, 28078, United States
Southern Oncology Specialists
Huntersville, North Carolina, 28078, United States
Presbyterian Hospital Matthews
Matthews, North Carolina, 28105, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Hospital East
Columbus, Ohio, 43205, United States
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43210, United States
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
James Care in Kenny
Columbus, Ohio, 43221, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033-0850, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Vincent Armenio, MD
East Providence, Rhode Island, 02914, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37130, United States
Sarah Cannon Research Institute (Administration)
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute (Pharmacy)
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
Vanderbilt Cancer Clinic
Nashville, Tennessee, 37232-5536, United States
The Vanderbilt Chemo Clinic
Nashville, Tennessee, 37232-7610, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
Dallas, Texas, 75390-9015, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
University of Texas Southwestern University Hospital - Zale Lipshy
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, 75390, United States
The University of Texas
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Lisa Nakatsu, RPh (Drug Shipment Address)
Seattle, Washington, 98122, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
East Melbourne, Victoria, 3002, Australia
Department of Medical Oncology
Nedlands, Western Australia, 6009, Australia
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110, Brazil
Instituto Nacional do Câncer - INCA
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
Associacao Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Fundacao Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Fundacao Antonio Prudente
São Paulo, São Paulo, 01509-900, Brazil
UMHAT Tsaritsa Yoanna - ISUL
Sofia, Bulgaria, 1527, Bulgaria
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
Sofia, Bulgaria, 1756, Bulgaria
MBAL Voennomeditsinska Academia, MMA HAT Sofia
Sofia, 1606, Bulgaria
MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
Varna, 9002, Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Alberta Health Services, Holy Cross Site
Calgary, Alberta, T2S 3C3, Canada
Office of Dr. John McWhae
Calgary, Alberta, T2V 2C4, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Dr. Georges-L. Dumont Regional Hospital
Moncton, New Brunswick, E1C 2Z3, Canada
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Dr. Dana Blakolmer and Associates
Oshawa, Ontario, L1J 8N8, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, K1H 8L6, Canada
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospsital
Montreal, Quebec, H3T 1E2, Canada
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5, Canada
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department
Beijing, 100021, China
307 Hospital of PLA
Beijing, 100071, China
Guangdong General Hospital
Guangzhou, 510080, China
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, 200030, China
Shanghai Chest Hospital
Shanghai, 200030, China
Zhongshan Hospital Fudan University / Respiratory Department
Shanghai, 200032, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Centre Francois Baclesse
Caen, 14076, France
Centre Georges-François Leclerc
Dijon, 21079, France
Hopital Albert Michallon
Grenoble, 38043, France
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Marseille, 13915, France
Centre Antoine Lacassagne
Nice, 06189, France
Hospital Cochin
Paris, 75014, France
Hopital Tenon
Paris, 75970, France
Centre Rene Gauducheau / Service d'Oncologie Medicale
Saint-Herblain, 44805, France
Institut Gustave Roussy
Villejuif, 94805, France
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
Cologne, 50937, Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden
Dresden, 01307, Germany
Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung
Essen, 45122, Germany
Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie
Großhansdorf, 22927, Germany
Ambulantes Krebszentrum Hamburg
Hamburg, 22527, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie
München, 80336, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
HSK Dr.- Horst-Schmidt-Kliniken
Wiesbaden, 65199, Germany
University General Hospital of Heraklion/ Department of Clinical Oncology
Heraklion, Crete, 71110, Greece
General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department
Eksochi, Thessaloniki, 57010, Greece
General Hospital of Chest Diseases of Athens "Sotiria"
Athens, 11527, Greece
Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital
Pokfulam, Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Tuen Mun Hospital, Department of Clinical Oncology
Tuen Mun, New Territories, Hong Kong
Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia
Budapest, 1121, Hungary
Semmelweis Egyetem Pulmonologia Intezet
Budapest, 1125, Hungary
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika
Debrecen, 4032, Hungary
Veszprem Megyei Onkormanyzat Tudogyogyintezete
Farkasgyepű, 8582, Hungary
Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly
Székesfehérvár, 8000, Hungary
Pest Megyei Tudogyogyintezet, III. Osztaly
Törökbálint, 2045, Hungary
Aseptic Compounding Unit
Dublin, Dublin, 8, Ireland
Department of Medical Oncology
Dublin, Dublin, Dublin 8, Ireland
Department of Medical Oncology
Galway, Ireland, Ireland
Merlin Park Imaging Centre
Galway, Ireland, Ireland
Pharmacy Aseptic Services Unit
Galway, Ireland, Ireland
Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera
Avellino, 83100, Italy
S.C. Oncologia Medica
Florence, 50134, Italy
Oncologia Medica A
Genova, 16132, Italy
Ospedale Versilia, Oncologia Medica
Lido Di Camaiore (LU), 55043, Italy
Ospedale San Luca
Lucca, 55100, Italy
Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
Milan, 20132, Italy
Farmacia Istituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk
Milan, 20162, Italy
Nuovo Ospedale San Gerardo
Monza, 20900, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), 10043, Italy
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
Perugia, 06156, Italy
Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani
Roma, 00152, Italy
Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette
Torino, 10126, Italy
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kinki University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
National Kyushu Cancer Center/Department of Thoracic Oncology
Fukuoka, 811-1395, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952, Poland
Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
Olsztyn, Poland, 10-344, Poland
Ars Medica
Olsztyn, Poland, 10-357, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej
Olsztyn, Poland, 10-561, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, 10-357, Poland
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, 60-569, Poland
Zaklad Diagnostyki Obrazowej
Poznan, 60-569, Poland
Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic
Kazan', 420029, Russia
State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"
Moscow, 115478, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
Saint Petersburg, 197022, Russia
Research Institute of Pulmonology
Saint Petersburg, 197089, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
National Cancer Center, Center for Lung Cancer
Gyeonggi-do, 410-769, South Korea
Seoul National University Hospital / Department of Internal Medicine
Seoul, 110-744, South Korea
Samsung Medical Center, Sungkyunkwan Univ School of Medicine
Seoul, 135-710, South Korea
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Hospital Del Mar
Barcelona, Barcelona, 08003, Spain
Hospital General Universitari Vall D´Hebron
Barcelona, Barcelona, 08035, Spain
Institut Catala D'Oncologia - Hospital Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Consorcio Hospitalario Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Universitario Virgen Del Rocio
Seville, Sevilla, 41013, Spain
Hospital de Navarra
Pamplona, 31008, Spain
Karolinska Universitetssjukhuset, Onkologiska kliniken
Stockholm, 171 76, Sweden
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital, Department of Internal Medicine
Taipei, 100, Taiwan
Taipei Veterans General Hospital, Chest Department
Taipei, 112, Taiwan
Cancer and Haematology Centre,
Headington, Oxford, OX3 7LJ, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Nuffield Health Wessex Hospital
Eastleigh, SO53 2DW, United Kingdom
Department of Oncology
London, NW3 2QG, United Kingdom
Kings College London at Guy's Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Christie Hospital NHS Trust, Department of Medical Oncology
Manchester, M20 4BX, United Kingdom
Somers Cancer Research Building, M824
Southampton, SO16 6YD, United Kingdom
Related Publications (7)
Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.
PMID: 30822515DERIVEDBlackhall 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.
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Pharmacogenetic analysis of renal adverse events was not performed as no gene alleles have been identified in published literature with statistically significant association with renal toxicity to support a case control association analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 3, 2009
Study Start
January 1, 2010
Primary Completion
March 1, 2015
Study Completion
December 1, 2015
Last Updated
January 13, 2017
Results First Posted
June 9, 2016
Record last verified: 2016-11