Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932451
First received: June 30, 2009
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: PF-02341066
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Type, incidence, severity, seriousness and relationship to study medication of adverse events and laboratory test abnormalities [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Patient reported symptoms of lung cancer and health-related quality of life [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of PF-02341066 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Types of EML4-ALK fusion variants and ALK gene expression [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Protein expression of identified biomarkers in serial tumor samples (when available) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Time to Tumor Response [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • QTc [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • genotypes of alleles possibly associated with adverse hepatic or renal drug reactions [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1100
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-0231066 Drug: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932451

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Arkansas
University of Arkansas for Medical Research Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Tower Hematology Oncology Medical Group Recruiting
Beverly Hills, California, United States, 90211-1850
Tower Cancer Research Foundation Recruiting
Beverly Hills, California, United States, 90211
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92037
UCSD Medical Center - La Jolla Recruiting
La Jolla, California, United States, 92093-0698
University of California-Los Angeles Recruiting
Los Angeles, California, United States, 90095
Ronald Reagen University of California-Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90095
UCLA Opthalmic Oncology Center Recruiting
Los Angeles, California, United States, 90095
Drug Shipping Address [IRB number 09-11-100]: Ronald Reagen University of California-Los Angeles Recruiting
Los Angeles, California, United States, 90095-6984
Ship Drug To : Lorene Kong- University of California, Irvine-Pharmacy Recruiting
Orange, California, United States, 92868-3298
University of California, Irvine-Medical Center Recruiting
Orange, California, United States, 92868-3298
Stanford University-Cancer Center Active, not recruiting
Palo Alto, California, United States, 94305
UC Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
UCSD Medical Center - Hillcrest Recruiting
San Diego, California, United States, 92103
Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory Recruiting
Santa Monica, California, United States, 90404
UCLA Hematology Oncology-Santa Monica Recruiting
Santa Monica, California, United States, 90404
University of California-Los Angeles Recruiting
Santa Monica, California, United States, 90404
Redwood Regional Medical Group Inc Terminated
Santa Rosa, California, United States, 95403
United States, Colorado
DRUG SHIPMENT: University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Rocky Mountain Lions Eye Institute Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Kaiser Permanente Recruiting
Denver, Colorado, United States, 80205
Kaiser Permanente Recruiting
Lafayette, Colorado, United States, 80026
United States, Connecticut
Clinical Trial Office Recruiting
New Haven, Connecticut, United States, 06519
Drug Shipping for Yale; C/O Thomas Ferenez, RPh, BCOP Recruiting
New Haven, Connecticut, United States, 06510
Smilow Cancer Hospital at Yale New Haven Recruiting
New Haven, Connecticut, United States, 06510
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Michael and Dianne Bienes Cancer Center, Holy Cross Hospital Terminated
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute Active, not recruiting
Hollywood, Florida, United States, 33021
Cancer Center of South Florida Foundation, Inc. Active, not recruiting
Lake Worth, Florida, United States, 33461
Memorial Cancer Center (West) Active, not recruiting
Pembroke Pines, Florida, United States, 33028
H Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institution Recruiting
Atlanta, Georgia, United States, 30322
Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
Emory University Clinic Recruiting
Atlanta, Georgia, United States, 30322
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Georgia Cancer Specialists - Administrative Annex Active, not recruiting
Atlanta, Georgia, United States, 30341
MCG Health Cancer Center Pharmacy Terminated
Augusta, Georgia, United States, 30912
MCG Health System Pharmacy (Drug Shipment Only) Terminated
Augusta, Georgia, United States, 30912
Medical College of Georgia Terminated
Augusta, Georgia, United States, 30912
Georgia Cancer Specialists-Stemmer Active, not recruiting
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists-Macon Active, not recruiting
Macon, Georgia, United States, 31217
Georgia Cancer Specialists-Kennestone Active, not recruiting
Marietta, Georgia, United States, 30060
Georgia Cancer Specialists-Northside Active, not recruiting
Sandy Springs, Georgia, United States, 30342
United States, Hawaii
University of Hawaii - Cancer Research Center of Hawaii Terminated
Honolulu, Hawaii, United States, 96813
OnCare Hawaii, Inc. Terminated
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center East Terminated
Honolulu, Hawaii, United States, 96817
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Ingalls Memorial Hospital Terminated
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital (Drug Shipment Only) Terminated
Harvey, Illinois, United States, 60426
Monroe Medical Associates Terminated
Harvey, Illinois, United States, 60426
Monroe Medical Associates Terminated
Tinley Park, Illinois, United States, 60477
United States, Indiana
Indiana University Hospital Clarian Health Active, not recruiting
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Ship drug to: Investigational Drug Services Active, not recruiting
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
Springmill Medical Clinic Active, not recruiting
Indianopolis, Indiana, United States, 46290
Monroe Medical Associates Terminated
Munster, Indiana, United States, 46321
The Community Hospital Terminated
Munster, Indiana, United States, 46321
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21231
The Harry and Jeanette Cancer Research Building Active, not recruiting
Baltimore, Maryland, United States, 21231
National Institutes of Health National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusette General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Beth Isreal Deaconess Medical Center, Pharmacy FD B18 Recruiting
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute/Pharmacy Recruiting
Boston, Massachusetts, United States, 02215
Beth Isreal Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Massachussetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Lawrence and Idell Weisberg Cancer Treatment Center Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Siteman Cancer Center- West County Recruiting
Creve Coeur, Missouri, United States, 63141
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110-1094
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Siteman Cancer Center Recruiting
St. Peters, Missouri, United States, 63376
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7680
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0001
United States, New Mexico
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87131
University of New Mexico Eye Clinic Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
NSLIJ Health System/Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavillion Recruiting
New York, New York, United States, 10022
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians Active, not recruiting
Oneida, New York, United States, 13421
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians Active, not recruiting
Oswego, New York, United States, 13126
SUNY Upstate Medical University, Regional Oncology Center Active, not recruiting
Syracuse, New York, United States, 13210-2306
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians Active, not recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
All shipment of study drug should go to: Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals, The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Presbyterian Hospital Cancer Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
Presbyterian Hospital Huntersville Active, not recruiting
Huntersville, North Carolina, United States, 28078
Southern Oncology Specialists Active, not recruiting
Huntersville, North Carolina, United States, 28078
Presbyterian Hospital Matthews Active, not recruiting
Matthews, North Carolina, United States, 28105
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
James Care in Kenny Recruiting
Columbus, Ohio, United States, 43221
The Ohio State University Hospital East Recruiting
Columbus, Ohio, United States, 43205
The Ohio State University James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University-Pacific Oncology Terminated
Beaverton, Oregon, United States, 97006
Oregon Health and Science University-Pacific Oncology Terminated
Gresham, Oregon, United States, 97030
Oregon Health and Science University-Pacific Oncology Terminated
Portland, Oregon, United States, 97210
Oregon Health and Science University Terminated
Portland, Oregon, United States, 97239
OHSU Knight Cancer Institute Terminated
Portland, Oregon, United States, 97216
Oregon Health and Science University-Pacific Oncology Terminated
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute Terminated
Hershey, Pennsylvania, United States, 17033-0850
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Pharma Resource Terminated
East Providence, Rhode Island, United States, 02915
Vincent Armenio, MD Terminated
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Medical University of South Carolina - Hollings Cancer Center Active, not recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Tennessee Oncology, PLLC Active, not recruiting
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC Active, not recruiting
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC Active, not recruiting
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC Active, not recruiting
Hermitage, Tennessee, United States, 37076
Tennessee Oncology, PLLC Active, not recruiting
Lebanon, Tennessee, United States, 37087
Tennessee Oncology, PLLC Active, not recruiting
Murfreesboro, Tennessee, United States, 37130
Sarah Cannon Research Institute (Administration) Active, not recruiting
Nashville, Tennessee, United States, 37203
Sarah Cannon Research Institute (Pharmacy) Active, not recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt Cancer Clinic Recruiting
Nashville, Tennessee, United States, 37232-5536
Tennessee Oncology, PLLC Active, not recruiting
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC Active, not recruiting
Nashville, Tennessee, United States, 37211
Tennessee Oncology, PLLC Active, not recruiting
Nashville, Tennessee, United States, 37203
The Vanderbilt Chemo Clinic Recruiting
Nashville, Tennessee, United States, 37232-7610
Tennessee Oncology, PLLC Active, not recruiting
Nashville, Tennessee, United States, 37207
Tennessee Oncology, PLLC Active, not recruiting
Smyrna, Tennessee, United States, 37167
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
University of Texas Southwestern University Hospital - St. Paul Recruiting
Dallas, Texas, United States, 75232
University of Texas Southwestern University Hospital - Zale Lipshy Recruiting
Dallas, Texas, United States, 75235
The University of Texas Recruiting
Houston, Texas, United States, 77030
United States, Washington
University of Washington Medical Center Active, not recruiting
Seattle, Washington, United States, 98195
Seattle Cancer Care Alliance Active, not recruiting
Seattle, Washington, United States, 98109
Swedish Cancer Institute Active, not recruiting
Seattle, Washington, United States, 98104
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
Lisa Nakatsu, RPh (Drug Shipment Address) Active, not recruiting
Seattle, Washington, United States, 98122
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Royal Adelaide Hospital, Department of Medical Oncology Active, not recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology Recruiting
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Department of Medical Oncology Terminated
Nedlands, Western Australia, Australia, 6009
Brazil
Nucleo de Oncologia da Bahia Recruiting
Salvador, BA, Brazil, 40170-110
Instituto Nacional do Câncer - INCA Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20231 -050
Associacao Hospital de Caridade de Ijui Terminated
Ijui, RS, Brazil, 98700-000
Hospital Sao Lucas da PUCRS Recruiting
Porto Alegre, RS, Brazil, 90610-000
Irmandade da Santa Casa de Misericordia de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90050-170
Fundacao Hospital Amaral Carvalho Terminated
Jau, Sao Paulo, Brazil, 17210-120
Fundacao Pio XII Hospital de Cancer de Barretos Active, not recruiting
Barretos, SP, Brazil, 14784-400
Fundacao Antonio Prudente Terminated
Sao Paulo, SP, Brazil, 01509-900
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Bulgaria
MBAL Serdika, Otdelenie po meditsinska onkologia Active, not recruiting
Sofia, Bulgaria, 1303
MBAL Voennomeditsinska Academia, MMA HAT Sofia Active, not recruiting
Sofia, Bulgaria, 1606
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya Terminated
Sofia, Bulgaria, 1756
UMBAL Tsaritsa Yoanna - ISUL Active, not recruiting
Sofia, Bulgaria, 1527
MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi Terminated
Varna, Bulgaria, 9002
Canada, Alberta
Alberta Health Services, Holy Cross Site Terminated
Calgary, Alberta, Canada, T2S 3C3
Office of Dr. John McWhae Terminated
Calgary, Alberta, Canada, T2V 2C4
Tom Baker Cancer Centre Terminated
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute Active, not recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Dr. Georges-L. Dumont Regional Hospital Terminated
Moncton, New Brunswick, Canada, E1C 2Z3
Dr. Leon Richard Oncology Centre Terminated
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Dr. Dana Blakolmer and Associates Recruiting
Oshawa, Ontario, Canada, L1J 8N8
RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM) Terminated
Montreal, Quebec, Canada, H2L 4M1
Jewish General Hospsital Terminated
Montreal, Quebec, Canada, H3T 1E2
Montreal General Hospital Terminated
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital Terminated
Montreal, Quebec, Canada, H3A 1A1
St. Mary's Hospital Center Terminated
Montreal, Quebec, Canada, H3T 1M5
China, Jiangsu
Nanjing Bayi Hospital Recruiting
Nanjing, Jiangsu, China, 210002
China
307 Hospital of PLA Recruiting
Beijing, China, 100071
Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department Recruiting
Beijing, China, 100021
Guangdong General Hospital Recruiting
Guangzhou, China, 510080
SUN Yat-Sen University Cancer Center Recruiting
Guangzhou, China, 510060
Shanghai Chest Hospital Recruiting
Shanghai, China, 200030
Shanghai Chest Hospital/Department of Pulmonary Medicine Recruiting
Shanghai, China, 200030
Shanghai Pulmonary Hospital Recruiting
Shanghai, China, 200433
Zhongshan Hospital Fudan University / Respiratory Department Recruiting
Shanghai, China, 200032
France
Centre Francois Baclesse Active, not recruiting
Caen Cedex 05, France, 14076
Centre Georges-François Leclerc Recruiting
Dijon, France, 21079
Hopital Albert Michallon Recruiting
Grenoble Cedex 09, France, 38043
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Recruiting
Marseille Cedex 20, France, 13915
Centre Antoine Lacassagne Active, not recruiting
NICE Cedex 2, France, 06189
Groupe Hospitalier Cochin Active, not recruiting
Paris Cedex 14, France, 75679
Hopital Tenon Recruiting
Paris cedex 20, France, 75970
Centre Rene Gauducheau / Service d'Oncologie Medicale Active, not recruiting
St Herblain Cedex, France, 44805
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Germany
Universitaetsklinik Carl-Gustav-Carus Dresden Recruiting
Dresden, Germany, 01307
Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung Recruiting
Essen, Germany, 45122
Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie Recruiting
Grosshansdorf, Germany, 22927
Ambulantes Krebszentrum Hamburg Active, not recruiting
Hamburg, Germany, 22527
Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren Recruiting
Heidelberg, Germany, 69126
St. Vincentius-Kliniken Karlsruhe Recruiting
Karlsruhe, Germany, 76137
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin Active, not recruiting
Koeln, Germany, 50937
Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie Recruiting
Muenchen, Germany, 80336
Pius-Hospital Oldenburg Recruiting
Oldenburg, Germany, 26121
HSK Dr.- Horst-Schmidt-Kliniken GmbH, Haematologie/Onkologie, Innere Medizin III Recruiting
Wiesbaden, Germany, 65199
Greece
University General Hospital of Heraklion/ Department of Clinical Oncology Recruiting
Heraklion, Crete, Greece, 71110
General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department Terminated
Exohi, Thessaloniki, Greece, 57010
General Hospital of Chest Diseases of Athens "Sotiria" Active, not recruiting
Athens, Greece, 11527
Hong Kong
Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital Active, not recruiting
Pokfulam, Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Active, not recruiting
Shatin, New Territories, Hong Kong
Tuen Mun Hospital, Department of Clinical Oncology Recruiting
Tuen Mun, New Territories, Hong Kong
Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia Active, not recruiting
Budapest, Hungary, 1121
Semmelweis Egyetem Pulmonologia Intezet Terminated
Budapest, Hungary, 1125
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika Active, not recruiting
Debrecen, Hungary, 4032
Veszprem Megyei Onkormanyzat Tudogyogyintezete Terminated
Farkasgyepu, Hungary, 8582
Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly Terminated
Szekesfehervar, Hungary, 8000
Pest Megyei Tudogyogyintezet, III. Osztaly Terminated
Torokbalint, Hungary, 2045
Ireland
Department of Medical Oncology Recruiting
Dublin 8, Ireland
Department of Medical Oncology Terminated
Galway, Ireland
Italy
Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera Active, not recruiting
Avellino, Italy, 83100
S.C. Oncologia Medica Recruiting
Firenze, Italy, 50134
Oncologia Medica A Terminated
Genova, Italy, 16132
Ospedale Versilia, Oncologia Medica Terminated
Lido di Camaiore (LU), Italy, 55043
Ospedale San Luca Recruiting
Lucca, Italy, 55100
Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk Active, not recruiting
Milano, Italy, 20162
Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative Recruiting
Milano, Italy, 20132
Nuovo Ospedale San Gerardo Recruiting
Monza, Italy, 20052
Azienda Ospedaliera Universitaria San Luigi Gonzaga Recruiting
Orbassano (TO), Italy, 10043
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia Recruiting
Perugia, Italy, 06132
Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani Active, not recruiting
Roma, Italy, 00152
Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette Terminated
Torino, Italy, 10126
Japan
Aichi cancer center central hospital/Thoracic Oncology Recruiting
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Hokkaido Cancer Center Recruiting
Sapporo, Hokkaido, Japan, 003-0804
Hyogo Cancer Center Recruiting
Akashi, Hyogo, Japan, 673-8558
Okayama University Hospital / Department of Respiratory Medicine and Allergy Recruiting
Okayama-city, Okayama, Japan, 700-8558
Kinki University Hospital Recruiting
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
National Kyushu Cancer Center/Department of Thoracic Oncology Recruiting
Fukuoka, Japan, 811-1395
The Cancer Institute Hospital of JFCR Active, not recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center, Center for Lung Cancer Recruiting
Gyeonggi-do, Korea, Republic of, 410-769
SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital / Department of Internal Medicine Recruiting
Seoul, Korea, Republic of, 110-744
Netherlands
Universitair Medisch Centrum Groningen / Afdeling Inwendige Geneeskunde Recruiting
Groningen, Netherlands, 9713 GZ
Poland
Klinika Onkologii i Radioterapii Recruiting
Gdansk, Poland, 80-952
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc Recruiting
Olsztyn, Poland, 10-357
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii Terminated
Poznan, Poland, 60-569
Russian Federation
Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic Terminated
Kazan, Russian Federation, 420029
State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS" Terminated
Moscow, Russian Federation, 115478
City Clinical Oncology Dispensary Recruiting
Saint-Petersburg, Russian Federation, 198255
Research Institute of Pulmonology Recruiting
Saint-Petersburg, Russian Federation, 197089
Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav Recruiting
Saint-Petersburg, Russian Federation, 197022
City Clinical Oncology Dispensary Recruiting
St. Petersburg, Russian Federation, 197022
Spain
Hospital Universitario Central de Asturias Active, not recruiting
Oviedo, Asturias, Spain, 33006
Hospital Universitari Germans Trias I Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Institut Catala D'Oncologia - Hospital Duran I Reynals Recruiting
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Consorcio Hospitalario Parc Tauli Active, not recruiting
Sabadell, Barcelona, Spain, 08208
Hospital de Navarra Active, not recruiting
Pamplona, Navarra, Spain, 31008
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil) Recruiting
A Coruña, Spain, 15006
Hospital Del Mar Recruiting
Barcelona, Spain, 08003
Hospital General Universitari Vall D´Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Marques de Valdecilla Terminated
Santander, Spain, 39008
Hospital Universitario Virgen Del Rocio Terminated
Sevilla, Spain, 41013
Sweden
Karolinska Universitetssjukhuset, Onkologiska kliniken Recruiting
Stockholm, Sweden, 171 76
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
National Taiwan University Hospital, Department of Internal Medicine Recruiting
Taipei, Taiwan, 100
Taipei Veterans General Hospital, Chest Department Active, not recruiting
Taipei, Taiwan, 112
United Kingdom
Cancer and Haematology Centre, Active, not recruiting
Headington, Oxford, United Kingdom, OX3 7LJ
Royal Marsden Hospital Active, not recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Nuffield Health Wessex Hospital Active, not recruiting
Eastleigh, United Kingdom, SO53 2DW
Department of Oncology Active, not recruiting
London, United Kingdom, NW3 2QG
Kings College London at Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Royal Marsden Hospital Active, not recruiting
London, United Kingdom, SW3 6JJ
Christie Hospital NHS Trust, Department of Medical Oncology Recruiting
Manchester, United Kingdom, M20 4BX
Somers Cancer Research Building, M824 Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00932451     History of Changes
Other Study ID Numbers: A8081005, 2009-012504-13
Study First Received: June 30, 2009
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lung Neoplasms ALK gene Crizotinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Crizotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014