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Trial record 1 of 1 for:    A8081005
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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932451
First received: June 30, 2009
Last updated: April 28, 2016
Last verified: April 2016
  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: 5 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Duration of Response (DR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death − first date of CR or PR that was subsequently confirmed + 1)/30.4.

  • Time to Tumor Response (TTR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.

  • Disease Control Rate (DCR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.

  • Progression Free Survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.

  • Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.

  • Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.

  • Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.

  • Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.

  • Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.

  • Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.

  • QTc Prolongation in Participants [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.

  • Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death − date of Cycle 1 Day 1 dose + 1)/30.4.

  • Probability of Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.

  • Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.

  • Mean Change From Baseline of QLQ-LC13 Scale Scores [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.


Enrollment: 1068
Study Start Date: January 2010
Study Completion Date: December 2015
Primary Completion Date: March 2015 (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   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211-1850
Moores UCSD Cancer Center
La Jolla, California, United States, 92037
UCSD Medical Center - La Jolla
La Jolla, California, United States, 92093-0698
Drug Shipping Address [IRB number 09-11-100]: Ronald Reagen University of California-Los Angeles
Los Angeles, California, United States, 90095-6984
Ronald Reagen University of California-Los Angeles Medical Center
Los Angeles, California, United States, 90095
UCLA Opthalmic Oncology Center
Los Angeles, California, United States, 90095
University of California-Los Angeles
Los Angeles, California, United States, 90095
Ship Drug To : Lorene Kong- University of California, Irvine-Pharmacy
Orange, California, United States, 92868-3298
University of California, Irvine-Medical Center
Orange, California, United States, 92868-3298
Stanford University-Cancer Center
Palo Alto, California, United States, 94305
UC Davis Cancer Center
Sacramento, California, United States, 95817
University of California Davis Medical Center
Sacramento, California, United States, 95817
UCSD Medical Center - Hillcrest
San Diego, California, United States, 92103
Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory
Santa Monica, California, United States, 90404
UCLA Hematology Oncology-Santa Monica
Santa Monica, California, United States, 90404
University of California-Los Angeles
Santa Monica, California, United States, 90404
Redwood Regional Medical Group Inc
Santa Rosa, California, United States, 95403
United States, Colorado
DRUG SHIPMENT: University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States, 80045
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Kaiser Permanente
Denver, Colorado, United States, 80205
Kaiser Permanente
Lafayette, Colorado, United States, 80026
United States, Connecticut
Drug Shipping for Yale; C/O Thomas Ferenez, RPh, BCOP
New Haven, Connecticut, United States, 06510
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Florida
Michael and Dianne Bienes Cancer Center, Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Cancer Center of South Florida Foundation, Inc.
Lake Worth, Florida, United States, 33461
Memorial Cancer Center (West)
Pembroke Pines, Florida, United States, 33028
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Winship Cancer Institution
Atlanta, Georgia, United States, 30322
Georgia Cancer Specialists - Administrative Annex
Atlanta, Georgia, United States, 30341
MCG Health Cancer Center Pharmacy
Augusta, Georgia, United States, 30912
MCG Health System Pharmacy (Drug Shipment Only)
Augusta, Georgia, United States, 30912
Medical College of Georgia
Augusta, Georgia, United States, 30912
Georgia Cancer Specialists-Stemmer
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists-Macon
Macon, Georgia, United States, 31217
Georgia Cancer Specialists-Kennestone
Marietta, Georgia, United States, 30060
Georgia Cancer Specialists-Northside
Sandy Springs, Georgia, United States, 30342
United States, Hawaii
OnCare Hawaii, Inc.
Honolulu, Hawaii, United States, 96813
University of Hawaii - Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center East
Honolulu, Hawaii, United States, 96817
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center (Attn: J Pi PharmD / A. Patel Pharm D)
Chicago, Illinois, United States, 60637
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Ingalls Memorial Hospital (Drug Shipment Only)
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Tinley Park, Illinois, United States, 60477
United States, Indiana
Indiana University Hospital Clarian Health
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Ship drug to: Investigational Drug Services
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Springmill Medical Clinic
Indianopolis, Indiana, United States, 46290
Monroe Medical Associates
Munster, Indiana, United States, 46321
The Community Hospital
Munster, Indiana, United States, 46321
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
The Harry and Jeanette Cancer Research Building
Baltimore, Maryland, United States, 21231
National Institutes of Health National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusette General Hospital
Boston, Massachusetts, United States, 02114
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Isreal Deaconess Medical Center, Pharmacy FD B18
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute/Pharmacy
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer lnstitute at Farmington Hllls
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110-1094
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Siteman Cancer Center
St. Peters, Missouri, United States, 63376
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, New Mexico
University of New Mexico Eye Clinic
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
United States, New York
NSLIJ Health System/Monter Cancer Center
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion
New York, New York, United States, 10022
Columbia University Medical Center
New York, New York, United States, 10032
IP Shipment: CUMC Research Pharmacy
New York, New York, United States, 10032
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10065
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Oneida, New York, United States, 13421
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Oswego, New York, United States, 13126
SUNY Upstate Medical University, Regional Oncology Center
Syracuse, New York, United States, 13210-2306
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Syracuse, New York, United States, 13210
United States, North Carolina
UNC Health Care
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
Presbyterian Hospital Cancer Center
Charlotte, North Carolina, United States, 28204
Presbyterian Hospital Huntersville
Huntersville, North Carolina, United States, 28078
Southern Oncology Specialists
Huntersville, North Carolina, United States, 28078
Presbyterian Hospital Matthews
Matthews, North Carolina, United States, 28105
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University Hospital East
Columbus, Ohio, United States, 43205
The Ohio State University Investigational Drug Services
Columbus, Ohio, United States, 43210
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
James Care in Kenny
Columbus, Ohio, United States, 43221
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033-0850
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Vincent Armenio, MD
East Providence, Rhode Island, United States, 02914
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, South Carolina
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Tennessee Oncology, PLLC
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
Sarah Cannon Research Institute (Administration)
Nashville, Tennessee, United States, 37203
Sarah Cannon Research Institute (Pharmacy)
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Vanderbilt Cancer Clinic
Nashville, Tennessee, United States, 37232-5536
The Vanderbilt Chemo Clinic
Nashville, Tennessee, United States, 37232-7610
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
Dallas, Texas, United States, 75390-9015
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of Texas Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States, 75390
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, United States, 75390
The University of Texas
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Lisa Nakatsu, RPh (Drug Shipment Address)
Seattle, Washington, United States, 98122
Swedish Medical Center
Seattle, Washington, United States, 98122
University of Washington Medical Center
Seattle, Washington, United States, 98195
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Department of Medical Oncology
Nedlands, Western Australia, Australia, 6009
Brazil
Nucleo de Oncologia da Bahia
Salvador, Bahia, Brazil, 40170-110
Instituto Nacional do Câncer - INCA
Rio de Janeiro, RJ, Brazil, 20231-050
Associacao Hospital de Caridade de Ijui
Ijui, RS, Brazil, 98700-000
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90050-170
Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Fundacao Hospital Amaral Carvalho
Jau, Sao Paulo, Brazil, 17210-120
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, SP, Brazil, 14784-400
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
Sao Paulo, SP, Brazil, 01246-000
Fundacao Antonio Prudente
Sao Paulo, SP, Brazil, 01509-900
Bulgaria
UMHAT Tsaritsa Yoanna - ISUL
Sofia, Bulgaria, 1527
MBAL Voennomeditsinska Academia, MMA HAT Sofia
Sofia, Bulgaria, 1606
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
Sofia, Bulgaria, 1756
MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
Varna, Bulgaria, 9002
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Alberta Health Services, Holy Cross Site
Calgary, Alberta, Canada, T2S 3C3
Office of Dr. John McWhae
Calgary, Alberta, Canada, T2V 2C4
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Dr. Georges-L. Dumont Regional Hospital
Moncton, New Brunswick, Canada, E1C 2Z3
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Dr. Dana Blakolmer and Associates
Oshawa, Ontario, Canada, L1J 8N8
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2L 4M1
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospsital
Montreal, Quebec, Canada, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
China, Guangdong
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Jiangsu
Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
China
Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department
Beijing, China, 100021
307 Hospital of PLA
Beijing, China, 100071
Guangdong General Hospital
Guangzhou, China, 510080
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, China, 200030
Shanghai Chest Hospital
Shanghai, China, 200030
Zhongshan Hospital Fudan University / Respiratory Department
Shanghai, China, 200032
Shanghai Pulmonary Hospital
Shanghai, China, 200433
France
Centre Francois Baclesse
Caen Cedex 05, France, 14076
Centre Georges-François Leclerc
Dijon, France, 21079
Hopital Albert Michallon
Grenoble Cedex 09, France, 38043
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Marseille Cedex 20, France, 13915
Centre Antoine Lacassagne
NICE Cedex 2, France, 06189
Hopital Tenon
Paris cedex 20, France, 75970
Hospital Cochin
Paris, France, 75014
Centre Rene Gauducheau / Service d'Oncologie Medicale
St Herblain Cedex, France, 44805
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden
Dresden, Germany, 01307
Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung
Essen, Germany, 45122
Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie
Grosshansdorf, Germany, 22927
Ambulantes Krebszentrum Hamburg
Hamburg, Germany, 22527
Thoraxklinik am Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69126
Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin
Koeln, Germany, 50937
Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie
Muenchen, Germany, 80336
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
HSK Dr.- Horst-Schmidt-Kliniken
Wiesbaden, Germany, 65199
Greece
University General Hospital of Heraklion/ Department of Clinical Oncology
Heraklion, Crete, Greece, 71110
General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department
Exohi, Thessaloniki, Greece, 57010
General Hospital of Chest Diseases of Athens "Sotiria"
Athens, Greece, 11527
Hong Kong
Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital
Pokfulam, Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Tuen Mun Hospital, Department of Clinical Oncology
Tuen Mun, New Territories, Hong Kong
Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia
Budapest, Hungary, 1121
Semmelweis Egyetem Pulmonologia Intezet
Budapest, Hungary, 1125
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika
Debrecen, Hungary, 4032
Veszprem Megyei Onkormanyzat Tudogyogyintezete
Farkasgyepu, Hungary, 8582
Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly
Szekesfehervar, Hungary, 8000
Pest Megyei Tudogyogyintezet, III. Osztaly
Torokbalint, Hungary, 2045
Ireland
Aseptic Compounding Unit
Dublin, Ireland, 8
Department of Medical Oncology
Dublin, Ireland, Dublin 8
Department of Medical Oncology
Galway, Ireland
Merlin Park Imaging Centre
Galway, Ireland
Pharmacy Aseptic Services Unit
Galway, Ireland
Italy
Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera
Avellino, Italy, 83100
S.C. Oncologia Medica
Firenze, Italy, 50134
Oncologia Medica A
Genova, Italy, 16132
Ospedale Versilia, Oncologia Medica
Lido di Camaiore (LU), Italy, 55043
Ospedale San Luca
Lucca, Italy, 55100
Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
Milano, Italy, 20132
Farmacia Istituto Europeo di Oncologia
Milano, Italy, 20141
Istituto Europeo di Oncologia
Milano, Italy, 20141
Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk
Milano, Italy, 20162
Nuovo Ospedale San Gerardo
Monza, Italy, 20900
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), Italy, 10043
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
Perugia, Italy, 06156
Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani
Roma, Italy, 00152
Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette
Torino, Italy, 10126
Japan
Aichi cancer center central hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Kinki University Hospital
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
National Kyushu Cancer Center/Department of Thoracic Oncology
Fukuoka, Japan, 811-1395
Okayama University Hospital / Department of Respiratory Medicine and Allergy
Okayama, Japan, 700-8558
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center, Center for Lung Cancer
Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Hospital / Department of Internal Medicine
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Sungkyunkwan Univ School of Medicine
Seoul, Korea, Republic of, 135-710
Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany
Olsztyn, Poland, 10-344
Ars Medica
Olsztyn, Poland, 10-357
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, Poland, 10-357
Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej
Olsztyn, Poland, 10-561
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, Poland, 60-569
Zaklad Diagnostyki Obrazowej
Poznan, Poland, 60-569
Russian Federation
Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic
Kazan, Russian Federation, 420029
State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"
Moscow, Russian Federation, 115478
Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav
Saint-Petersburg, Russian Federation, 197022
Research Institute of Pulmonology
Saint-Petersburg, Russian Federation, 197089
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 198255
City Clinical Oncology Dispensary
St. Petersburg, Russian Federation, 197022
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Institut Catala D'Oncologia - Hospital Duran I Reynals
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Consorcio Hospitalario Parc Tauli
Sabadell, Barcelona, Spain, 08208
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain, 15006
Hospital Del Mar
Barcelona, Spain, 08003
Hospital General Universitari Vall D´Hebron
Barcelona, Spain, 08035
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital de Navarra
Pamplona, Spain, 31008
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Universitario Virgen Del Rocio
Sevilla, Spain, 41013
Sweden
Karolinska Universitetssjukhuset, Onkologiska kliniken
Stockholm, Sweden, 171 76
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital, Department of Internal Medicine
Taipei, Taiwan, 100
Taipei Veterans General Hospital, Chest Department
Taipei, Taiwan, 112
United Kingdom
Cancer and Haematology Centre,
Headington, Oxford, United Kingdom, OX3 7LJ
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Nuffield Health Wessex Hospital
Eastleigh, United Kingdom, SO53 2DW
Department of Oncology
London, United Kingdom, NW3 2QG
Kings College London at Guy's Hospital
London, United Kingdom, SE1 9RT
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Christie Hospital NHS Trust, Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Somers Cancer Research Building, M824
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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
Results First Received: March 14, 2016
Last Updated: April 28, 2016
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016