Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT00932893
Previous Study | Return to List | Next Study

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932893
First received: June 30, 2009
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: PF-02341066
Drug: Pemetrexed
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]
    PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization until death (up to 112 weeks) ] [ Designated as safety issue: No ]
    OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.

  • Overall Survival Probability at Month 6 and Month 12 [ Time Frame: Month 6, 12 ] [ Designated as safety issue: No ]
    Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.

  • Percentage of Participants With Objective Response (OR) [ Time Frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]
    Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.

  • Percentage of Participants With Disease Control at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.

  • Percentage of Participants With Disease Control at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

  • Duration of Response (DR) [ Time Frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]
    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  • Time to Tumor Response (TTR) [ Time Frame: Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks) ] [ Designated as safety issue: No ]
    Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

  • Pre-Dose Plasma Concentration (Ctrough) of Crizotinib [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 5 ] [ Designated as safety issue: No ]
    Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.

  • Pre-Dose Plasma Concentration at Steady State (Ctrough, ss) of Crizotinib [ Time Frame: Pre-dose on Day 15 of Cycle 1 ] [ Designated as safety issue: No ]
    Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.

  • Number of Participants With Categorical Maximum QTcF for Crizotinib [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2 ] [ Designated as safety issue: Yes ]
    QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.

  • Percentage of Participants With Echinoderm Microtubule Associated Protein-Like 4-Anaplastic Lymphoma Kinase (EML4-ALK) Fusion Variants [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
  • Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
  • Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough [ Time Frame: Baseline up to end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
    TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.

  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks) ] [ Designated as safety issue: No ]
    EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.

  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13) [ Time Frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.

  • European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks) ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.


Enrollment: 347
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-02341066 Drug: PF-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Active Comparator: Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
Drug: Pemetrexed
Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Drug: Docetaxel
Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

  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 a central laboratory)
  • must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  • tumors must be measurable

Exclusion Criteria:

  • prior treatment with PF-02341066
  • current treatment in another 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: NCT00932893

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences, Winthrop Rockefeller Cancer Institute
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
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093-0698
UCSD Medical Center -La Jolla
La Jolla, California, United States, 92037
UCLA Hematology Oncology
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCLA Ophthalmic Oncology Center
Los Angeles, California, United States, 90095
University of California, Los Angeles
Los Angeles, California, United States, 90404
University of California-Los Angeles
Los Angeles, California, United States, 90095
Drug Shipping Address [IRB number 09-11-099]: Ronald Reagen University of California-Los Angeles
Los Angeles, California, United States, 90095-6984
University of California, Irvine-Medical Center
Orange, California, United States, 92868-3298
Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy
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 and Orthopaedic Hospital
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
Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion
Aurora, Colorado, United States, 80045
University of Colorado Denver (CTRC)
Aurora, Colorado, United States, 80045
Unviersity of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Kaiser Permanente
Denver, Colorado, United States, 80205
Kaiser Permanente
Lafayette, Colorado, United States, 80026
United States, Connecticut
Clinical Trial Office
New Haven, Connecticut, United States, 06519
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
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Cancer Center of South Florida Foundation, Inc.
Lake Worth, Florida, United States, 33461
Memorial Cancer Institute (West)
Pembroke Pines, Florida, United States, 33028
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institution
Atlanta, Georgia, United States, 30322
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Georgia Cancer Specialists-Administrative Annex
Atlanta, Georgia, United States, 30341
Emory University Clinic
Atlanta, Georgia, United States, 30322
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
Sandy Springs, Georgia, United States, 30342
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center East
Honolulu, Hawaii, United States, 96813
OnCare Hawaii, Inc.
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Monroe Medical Associates
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital (Drug Shipment Only)
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Tinley Park, Illinois, United States, 60477
United States, Indiana
Monroe Medical Associates
Hobart, Indiana, United States, 46342
Springmill Medical Clinic
Indianapolis, Indiana, United States, 46290
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Ship Drug to: Investigational Drug Services
Indianapolis, Indiana, United States, 46202
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Monroe Medical Associates
Munster, Indiana, United States, 46321
The Community Hospital
Munster, Indiana, United States, 46321
United States, Maryland
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Isreal Deaconess Medical Center, Pharmacy FD B18
Boston, Massachusetts, United States, 02215
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
DFCI/Pharmacy (Drug Shipment Only)
Boston, Massachusetts, United States, 02215
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusette General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Lawrence and Idell Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Siteman Cancer Center- West County
Creve Coeur, Missouri, United States, 63141
Washington University, School of Medicine
St. Louis, Missouri, United States, 63110
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110-1094
Siteman Cancer Center
St. Peters, Missouri, United States, 63376
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
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
Columbia University Medical Center
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Memorial Sloan-Kettering Rockefeller Outpatient Pavillion
New York, New York, United States, 10022`
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
Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians
Syracuse, New York, United States, 13210
SUNY Upstate Medical University
Syracuse, New York, United States, 13210-2306
United States, North Carolina
Investigational Drug Service, Pharmacy Department, UNC Hospitals
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
James Care in Kenny
Columbus, Ohio, United States, 43221
The Ohio State University Hospital East
Columbus, Ohio, United States, 43205
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University-Pacific Oncology
Beaverton, Oregon, United States, 97006
Oregon Health and Science University-Pacific Oncology
Gresham, Oregon, United States, 97030
Oregon Health and Science University
Portland, Oregon, United States, 97239
Oregon Health and Science University-Pacific Oncology
Portland, Oregon, United States, 97210
Oregon Health and Science University-Pacific Oncology
Tualatin, Oregon, United States, 97062
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 at Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Medical Center-Shadyside
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
Vincent Armenio, MD
East Providence, Rhode Island, United States, 02914
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
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
The Vanderbilt Cancer Clinic
Nashville, Tennessee, United States, 37232-5536
The Vanderbilt Chemo Pharmacy
Nashville, Tennessee, United States, 37232-7610
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
The University of Texas
Houston, Texas, United States, 77030
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Investigational Drug Service
Seattle, Washington, United States, 98122
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
Sydney Cancer Centre
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, BA, Brazil, 40170-110
Instituto Nacional de 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
Fundacao Antonio Prudente
Sao Paulo, SP, Brazil, 01509-900
Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP
Sao Paulo, SP, Brazil, 01246-000
Bulgaria
MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie
Plovdiv, Bulgaria, 4004
UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya
Sofia, Bulgaria, 1527
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya
Sofia, Bulgaria, 1756
MBAL Voennomeditsinska Academia, MMA HAT Sofia
Sofia, Bulgaria, 1606
MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi
Varna, Bulgaria, 9002
Canada, Alberta
Alberta Health Services, Holy Cross Site
Calgary, Alberta, Canada, T2S 3C3
Office of Dr. John McWhae
Calgary, Alberta, Canada, T2V 2C4
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
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
Dr. Dana Blakolmer and Associates
Oshawa, Ontario, Canada, L1J 8N8
RSM Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
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
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Jiangsu
Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
China
307 Hospital of PLA
Beijing, China, 100071
Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC
Beijing, China, 100021
Shanghai Chest Hospital
Shanghai, China, 200030
Zhongshan Hospital Fudan University / Respiratory Department
Shanghai, China, 200032
Shanghai Pulmonary Hospital/Dept. of Oncology
Shanghai, China, 200433
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, China, 200030
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
Groupe Hospitalier Cochin
Paris Cedex 14, France, 75679
Hopital Tenon / Service de Pneumologie
Paris cedex 20, France, 75970
Centre Rene Gauducheau / Service d'Oncologie Medicale
St Herblain Cedex, France, 44805
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Universitaetsklinik 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, Internistische Onkologie der Thoraxtumoren
Heidelberg, Germany, 69126
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, Germany, 76137
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 GmbH, Haematologie/Onkologie, Innere Medizin III
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 és Pulmonologiai Intezet, VI. Bronchologia
Budapest, Hungary, 1121
Semmelweis Egyetem Pulmonologia Intezet
Budapest, Hungary, 1125
Debreceni Egyetem Orvos- és Egészségtudományi 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 8, Ireland
Department of Medical Oncology
Dublin 8, Ireland
Department of Medical Oncology
Galway, Ireland
Italy
Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera
Avellino, Italy, 83100
Azienda Ospedaliero-Universitaria Careggi
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
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, 20052
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), Italy, 10043
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
Perugia, Italy, 06132
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 /Thoracic Oncology
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
Okayama University Hospital / Department of Respiratory Medicine and Allergy
Okayama-city, Okayama, Japan, 700-8558
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
Fukuoka, Japan, 811-1395
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center, Center for Lung Cancer
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital / Department of Internal Medicine
Seoul, Korea, Republic of, 110-744
Netherlands
Universitair Medisch Centrum Groningen / Afdeling Inwendige Geneeskunde
Groningen, Netherlands, 9713 GZ
Poland
Klinika Onkologii i Radioterapii
Gdansk, Poland, 80-952
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
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
Research Institute of Pulmonology
Saint-Peterburg, Russian Federation, 197089
Saint-Petersburg State Medical University
Saint-Petersburg, Russian Federation, 197022
State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region
Sochi, Russian Federation, 354057
City Clinical Oncology Dispensary
St. Petersburg, Russian Federation, 198255
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
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)
A Coruña, 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 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
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
Cancer and Haematology Centre,
Oxford, United Kingdom, OX3 7LJ
Southampton University Hospitals NHS Trust
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: NCT00932893     History of Changes
Other Study ID Numbers: A8081007, 2009-012595-27
Study First Received: June 30, 2009
Results First Received: March 13, 2013
Last Updated: October 29, 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
Docetaxel
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014