A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014)
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154140
First received: June 29, 2010
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Squamous Lung Cancer |
Drug: treatment |
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 Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With Objective Response. [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
- Plasma concentrations of crizotinib (including its active moieties, if appropriate) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- Patient reported outcome measures of pain, dyspnea, or cough, disease/treatment-related symptoms, and general health status and Health Care Resource Utilization [HCRU] [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- Overall Survival [OS] at 12 months, 18 months and overall [ Time Frame: 35 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 334 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
|
| Active Comparator: B |
Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
- Positive for translocation or inversion events involving the ALK gene locus
- No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
- Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
- 18 years of age or older with the exception of India which has an upper age limit of 65 years old
Exclusion Criteria:
- Current treatment on another therapeutic clinical trial.
- Prior therapy directly targeting ALK.
- Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
- Pregnancy or breastfeeding.
- Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
- Known HIV infection
- Known interstitial lung disease or interstitial fibrosis
- Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154140
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Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, California | |
| CCTAP | Active, not recruiting |
| Anaheim, California, United States, 92807 | |
| CCTAP | Active, not recruiting |
| Baldwin Park, California, United States, 91706 | |
| CCTAP | Active, not recruiting |
| Bellflower, California, United States, 90706 | |
| Tower Hematology Oncology Medical Group | Terminated |
| Beverly Hills, California, United States, 90211-1850 | |
| Tower Cancer Research Foundation | Terminated |
| Beverly Hills, California, United States, 90211-1850 | |
| CCTAP | Active, not recruiting |
| Fontana, California, United States, 92335 | |
| CCTAP | Active, not recruiting |
| Harbor City, California, United States, 90710 | |
| CCTAP | Active, not recruiting |
| Irvine, California, United States, 92618 | |
| Records Management Only- Loma Linda Cancer Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Loma Linda University Cancer Center-Schuman Pavilion | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Loma Linda University Medical Center Pharmacy | Recruiting |
| Loma Linda, California, United States, 92354 | |
| CCTAP | Active, not recruiting |
| Los Angeles, California, United States, 90034 | |
| CCTAP | Active, not recruiting |
| Los Angeles, California, United States, 90027 | |
| CCTAP | Active, not recruiting |
| Panorama City, California, United States, 91402 | |
| CCTAP | Active, not recruiting |
| Riverside, California, United States, 92505 | |
| CTTAP | Active, not recruiting |
| San Diego, California, United States, 92120 | |
| Kaiser Permanente Southern California | Active, not recruiting |
| San Diego, California, United States, 92108 | |
| CCTAP | Active, not recruiting |
| San Marcos, California, United States, 92069 | |
| CCTAP | Active, not recruiting |
| Woodland Hills, California, United States, 91367 | |
| United States, District of Columbia | |
| Georgetown University Hospital | Terminated |
| Washington, District of Columbia, United States, 20007 | |
| Drug Shipment Address and Pharmacist Designees: | Terminated |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Lynn Cancer Institute Center for Hematology Oncology | Terminated |
| Boca Raton, Florida, United States, 33486 | |
| Investigational Drug Services | Recruiting |
| Orlando, Florida, United States, 32804 | |
| Cancer Institute of Florida | Recruiting |
| Orlando, Florida, United States, 32804 | |
| Florida Hospital | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Hematology and Oncology Consultants, PA | Recruiting |
| Orlando, Florida, United States, 32804 | |
| United States, Georgia | |
| Georgia Cancer Specialists | Recruiting |
| Atlanta, Georgia, United States, 30341 | |
| Winship Cancer Institute - Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Emory University Hospital Midtown | Not yet recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Emory University Hospital | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| The Emory Clinic | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Georgia Cancer Specialists | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Georgia Cancer Specialists | Recruiting |
| Macon, Georgia, United States, 31217 | |
| Georgia Cancer Specialists | Recruiting |
| Marietta, Georgia, United States, 30060 | |
| Georgia Cancer Specialists | Recruiting |
| Sandy Springs, Georgia, United States, 30342 | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Ship Drug To: Al Fisher, Pharm D. | Terminated |
| Harvey, Illinois, United States, 60426 | |
| Monroe Medical Associates | Terminated |
| Harvey, Illinois, United States, 60426 | |
| Ingalls Memorial Hospital | Terminated |
| Harvey, Illinois, United States, 60426 | |
| Monroe Medical Associates | Terminated |
| Tinley Park, Illinois, United States, 60477 | |
| United States, Indiana | |
| Methodist Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46206 | |
| Indiana University Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Health Services | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Monroe Medical Association | Terminated |
| Munster, Indiana, United States, 46321 | |
| The Community Hospital | Terminated |
| Munster, Indiana, United States, 46321 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | Terminated |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maine | |
| Maine Center for Cancer Medicine | Recruiting |
| Biddeford, Maine, United States, 04005 | |
| Maine Center for Cancer Medicine | Recruiting |
| Brunswick, Maine, United States, 04011 | |
| Maine Center for Cancer Medicine | Recruiting |
| Sanford, Maine, United States, 04073 | |
| Maine Center for Cancer Medicine | Recruiting |
| Scarborough, Maine, United States, 04074 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital (BWH) | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center (BIDMC) | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Dana-Farber Cancer Institute (DFCI) | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Karmanos Cancer Institute at Farmington Hills | Recruiting |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Missouri | |
| Siteman Cancer Center - West County | Recruiting |
| Creve Coeur, Missouri, United States, 63141 | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110-1094 | |
| Barnes-Jewish Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110-1094 | |
| Siteman Cancer Center | Recruiting |
| St. Peters, Missouri, United States, 63376 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| United States, New Jersey | |
| Hematology-Oncology Associates of Northern New Jersey | Active, not recruiting |
| Morristown, New Jersey, United States, 07962 | |
| United States, New Mexico | |
| UNM Eye Clinic | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Memorial Medical Center | Recruiting |
| Las Cruces, New Mexico, United States, 88011 | |
| 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 | |
| Department of Medicine MSG at SUNY HSC at Syracuse, Inc. | Recruiting |
| Oneida, New York, United States, 13421 | |
| Department of Medicine MSG at SUNY HSC at Syracuse, Inc. | Recruiting |
| Oswego, New York, United States, 13126 | |
| Department of Medicine MSG at SUNY HSC at Syracuse, Inc. | Recruiting |
| Syracuse, New York, United States, 13210 | |
| SUNY Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210-2306 | |
| United States, Oregon | |
| OHSU Knight Cancer Institute | Recruiting |
| Beaverton, Oregon, United States, 97006 | |
| OHSU Knight Cancer Institute | Recruiting |
| Gresham, Oregon, United States, 97030 | |
| OHSU Knight Cancer Institute | Recruiting |
| Portland, Oregon, United States, 97216 | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| OHSU Knight Cancer Institute | Recruiting |
| Portland, Oregon, United States, 97210 | |
| OHSU Knight Cancer Institute | Recruiting |
| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Terminated |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Rhode Island | |
| Vincent Armenio | Terminated |
| East Providence, Rhode Island, United States, 02914 | |
| Pharma Resource | Terminated |
| East Providence, Rhode Island, United States, 02915 | |
| United States, Tennessee | |
| Tennessee Oncology, PLLC | Terminated |
| Dickson, Tennessee, United States, 37055 | |
| Tennessee Oncology, PLLC | Terminated |
| Franklin, Tennessee, United States, 37067 | |
| Tennessee Oncology, PLLC | Terminated |
| Gallatin, Tennessee, United States, 37066 | |
| Tennessee Oncology, PLLC | Terminated |
| Hermitage, Tennessee, United States, 37076 | |
| Tennessee Oncology, PLLC | Terminated |
| Lebanon, Tennessee, United States, 37087 | |
| Tennessee Oncology, PLLC | Terminated |
| Murfreesboro, Tennessee, United States, 37130 | |
| Tennessee Oncology, PLLC | Terminated |
| Nashville, Tennessee, United States, 37203 | |
| Vanderbilt Oncology Pharmacy | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Tennessee Oncology, PLLC | Terminated |
| Nashville, Tennessee, United States, 37205 | |
| Sarah Cannon Research Institute | Terminated |
| Nashville, Tennessee, United States, 37203 | |
| Tennessee Oncology, PLLC | Terminated |
| Nashville, Tennessee, United States, 37207 | |
| Tennessee Oncology, PLLC | Terminated |
| Nashville, Tennessee, United States, 37211 | |
| Henry-Joyce Cancer Clinic | Recruiting |
| Nashville, Tennessee, United States, 37232-5536 | |
| Tennessee Oncology, PLLC | Terminated |
| Smyrna, Tennessee, United States, 37167 | |
| United States, Texas | |
| University of Texas Southwestern University Hospital - Zale Lipshy | Recruiting |
| Dallas, Texas, United States, 75235 | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390-8852 | |
| University of Texas Southwestern University Hospital - St. Paul | Recruiting |
| Dallas, Texas, United States, 75232 | |
| University of Texas MD Anderson Cancer Center | Terminated |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | Terminated |
| Seattle, Washington, United States, 98109 | |
| University of Washington Medical Center | Terminated |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53792-5666 | |
| Australia, New South Wales | |
| Macarthur Cancer Therapy Centre | Active, not recruiting |
| Campbelltown, New South Wales, Australia, 2560 | |
| Sydney Cancer Centre | Recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Department of Medical Oncology | Recruiting |
| St. Leonards, New South Wales, Australia, 2065 | |
| Australia, Queensland | |
| The Prince Charles Hospital | Recruiting |
| Chermside, Queensland, Australia, 4032 | |
| Townsville Hospital | Recruiting |
| Townsville, Queensland, Australia, 4814 | |
| Australia, South Australia | |
| Royal Adelaide Hospital, Department of Medical Oncology | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology | Recruiting |
| East Melbourne, Victoria, Australia, 3002 | |
| Peninsula Oncology Centre | Recruiting |
| Frankston, Victoria, Australia, 3199 | |
| Austria | |
| Landeskrankenhaus Salzburg | Recruiting |
| Salzburg, Austria, 5020 | |
| KH der Kreuzschwestern Wels-Grieskirchen | Recruiting |
| Wels, Austria, 4600 | |
| Belgium | |
| Universitair Ziekenhuis Brussel / Medische Oncologie | Recruiting |
| Brussel, Belgium, 1090 | |
| Cliniques Universitaires St Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Institut Jules Bordet, Centre des Tumeurs de l'ULB | Recruiting |
| Bruxelles, Belgium, 1000 | |
| Centre Hospitalier Notre Dame et Reine Fabiola, Service d'Oncologie | Recruiting |
| Charleroi, Belgium, 6000 | |
| UZ Antwerpen-Pneumologie | Recruiting |
| Edegem, Belgium, 2650 | |
| University Hospital Gent, Thoracic Oncology | Recruiting |
| Gent, Belgium, 9000 | |
| CHU Liege | Recruiting |
| Liege, Belgium, 4000 | |
| Heilig Hart Ziekenhuis Roeselare-Menen | Recruiting |
| Roeselare, Belgium, 8800 | |
| Brazil | |
| Instituto Nacional do Cancer - INCA | Recruiting |
| Rio de Janeiro, RJ, Brazil, 20230-130 | |
| Instituto Nacional de C�er - INCA | Recruiting |
| Rio de Janeiro, RJ, Brazil, 20231 -050 | |
| Associacao Hospital de Caridade de Ijui | Recruiting |
| Ijui, RS, Brazil, 98700-000 | |
| Hospital Sao Lucas da PUCRS | Recruiting |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Fundacao Pio XII Hospital de Cancer de Barretos | Recruiting |
| Barretos, SP, Brazil, 14784-400 | |
| Instituto do C�er do Estado de S�Paulo Octavio Frias de Oliveira - ICESP | Recruiting |
| Sao Paulo, SP, Brazil, 01246-000 | |
| Canada, Alberta | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B2H 2Y9 | |
| QEII Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| RSM Durham Regional Cancer Centre | Recruiting |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Canada, Quebec | |
| Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Jewish General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Royal Victoria Hospital | Recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| St. Mary's Hospital Centre | Recruiting |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Hopital Laval | Recruiting |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Chile | |
| Instituto Clinico Oncologico del Sur | Terminated |
| Temuco, Cautin, Chile, 4810469 | |
| Instituto Nacional del Cancer | Terminated |
| Independencia, Santiago, RM, Chile, 8380455 | |
| Hospital Clinico Universidad de Chile, Seccion de Oncologia | Active, not recruiting |
| Independencia, Santiago, RM, Chile, 8380456 | |
| China, Beijing | |
| 307 Hospital of PLA | Recruiting |
| Beijing, Beijing, China, 100071 | |
| China, Guangdong | |
| Guangdong General Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| China, Hubei | |
| Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center | Recruiting |
| Wuhan, Hubei, China, 430023 | |
| China, Jiangsu | |
| Nanjing Bayi Hospital | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| No.81 Hospital of the PLA | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| China, Sichuan | |
| Oncology Department, West China Hospital of Sichuan University | Recruiting |
| Chengdu, Sichuan, China, 610041 | |
| China | |
| Cancer Institute and Hospital (CIH), Chinese Academy of Medical Sciences | Recruiting |
| Beijing, China, 100021 | |
| Shanghai Chest Hospital/Department of Pulmonary Medicine | Recruiting |
| Shanghai, China, 200030 | |
| Shanghai Pulmonary Hospital/Dept. of Oncology | Recruiting |
| Shanghai, China, 200433 | |
| Finland | |
| Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka | Recruiting |
| Helsinki, Finland, 00290 | |
| Satakunnan keskussairaala/Keuhkosairauksien osasto A4 | Recruiting |
| Pori, Finland, 28500 | |
| Tampereen yliopistollinen sairaala | Recruiting |
| Tampere, Finland, 33520 | |
| France | |
| Hopital Avicenne, Service Oncologie Medicale | Recruiting |
| Bobigny Cedex, France, 93009 | |
| CHU de la C�de Nacre | Recruiting |
| Caen Cedex, France, 14033 | |
| CHU Grenoble | Recruiting |
| Grenoble Cedex, France, 38043 | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Centre Leon Berard | Recruiting |
| Lyon Cedex 08, France, 69373 | |
| APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Th�peutiques | Recruiting |
| Marseille Cedex 20, France, 13915 | |
| Hopital Arnaud de Villeneuve / CHU de Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Groupe Hospitalier Paris Saint Joseph | Not yet recruiting |
| Paris, France, 75014 | |
| Hopital Tenon, Service de Pneumologie | Recruiting |
| Paris cedex 20, France, 75970 | |
| Nouvel Hopital Civil - HSU - P�de Pathologie Thoracique - Service de Pneumologie | Recruiting |
| Strasbourg, France, 67091 | |
| Germany | |
| Zentralklinik Bad Berka GmbH | Recruiting |
| Bad Berka, Germany, 99437 | |
| Charite - Universitaetsmedizin Berlin, Campus Mitte | Recruiting |
| Berlin, Germany, 10117 | |
| Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren | Recruiting |
| Heidelberg, Germany, 69126 | |
| Universitaetsklinik Mainz III. Med. Klinik, Abt. Pneumologie | Recruiting |
| Mainz, Germany, 55131 | |
| Kliniken Maria Hilf GmbH | Recruiting |
| Moenchengladbach, Germany, 41063 | |
| Pius-Hospital Oldenburg | Recruiting |
| Oldenburg, Germany, 26121 | |
| HSK Dr.- Horst-Schmidt-Kliniken GmbH, Haematologie/Onkologie, Innere Medizin III | Recruiting |
| Wiesbaden, Germany, 65199 | |
| Hong Kong | |
| Department of Clinical Oncology, Queen Elizabeth Hospital | Recruiting |
| Kowloon, Hong Kong, 0 | |
| Prince of Wales Hospital | Recruiting |
| Shatin, Hong Kong, 0 | |
| India | |
| The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital), | Recruiting |
| Ahmedabad,, Gujarat, India, 380 016 | |
| Tata Memorial Centre, Tata Memorial Hospital, | Not yet recruiting |
| Mumbai, Maharashtra, India, 400012 | |
| Ireland | |
| Department of Medical Oncology | Recruiting |
| Dublin, Ireland | |
| Aseptic Compounding Unit | Recruiting |
| Dublin 8, Ireland | |
| Italy | |
| Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS | Recruiting |
| Aviano (PN), Italy, 33081 | |
| Istituto dei tumori Giovanni Paolo II | Recruiting |
| Bari, Italy, 70124 | |
| Ospedale Maggiore Bellaria | Recruiting |
| Bologna, Italy, 40139 | |
| Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella, Unit�perativa di Oncologia | Recruiting |
| Catanzaro, Italy, 88100 | |
| UO di Oncologia, Ospedale Civile, Azienda USL 6 di Livorno | Recruiting |
| Livorno, Italy, 57124 | |
| Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck | Recruiting |
| Milano, Italy, 20162 | |
| Fondazione IRCCS Istituto Nazionale Tumori | Recruiting |
| Milano, Italy, 20133 | |
| Dipartimento di Medicina,Unita' di Farmacologia Clinica Nuovi Farmaci, | Recruiting |
| Milano, Italy, 20141 | |
| A.O.R.N. Dei Colli Plesso Monaldi | Recruiting |
| Napoli, Italy, 80131 | |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga | Recruiting |
| Orbassano (TO), Italy, 10043 | |
| Oncologia Medica, Azienda Ospedaliera di Parma | Recruiting |
| Parma, Italy, 43100 | |
| SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia | Recruiting |
| Perugia, Italy, 06132 | |
| Azienda Ospedaliera Arcispedale Santa Maria Nuova | Recruiting |
| Reggio Emilia, Italy, 42100 | |
| Istituto Regina Elena, Struttura Complessa Oncologia Medica A | Recruiting |
| Roma, Italy, 00144 | |
| UO Oncologia Toracica 1, Dipartimento di Malattie Polmonari, Padiglione Maroncelli | Recruiting |
| Roma, Italy, 00152 | |
| Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria | Recruiting |
| Roma, Italy, 00168 | |
| Japan | |
| Aichi cancer center central hospital /Thoracic Oncology | Active, not recruiting |
| Nagoya, Aichi, Japan | |
| National Cancer Center Hospital East | Completed |
| Kashiwa, Chiba, Japan | |
| Shikoku Cancer Center / Internal medicine | Active, not recruiting |
| Matsuyama-shi, Ehime, Japan | |
| National Hospital Organization Hokkaido Cancer Center | Active, not recruiting |
| Sapporo, Hokkaido, Japan | |
| Hyogo Cancer Center | Active, not recruiting |
| Akashi, Hyogo, Japan | |
| Kanagawa Cardiovascular and Respiratory Center | Active, not recruiting |
| Yokohama, Kanagawa, Japan | |
| Tohoku University Hospital | Terminated |
| Sendai, Miyagi, Japan | |
| Okayama University Hospital | Terminated |
| Okayama-city, Okayama, Japan | |
| Kinki University Hospital | Active, not recruiting |
| Osakasayama-shi, Osaka, Japan | |
| Shizuoka Cancer Center | Active, not recruiting |
| Sunto-gun, Shizuoka, Japan | |
| National Cancer Center Hospital | Completed |
| Chuo-Ku, Tokyo, Japan | |
| National Hospital Organization, Yamaguchi-Ube Medical Center | Completed |
| Ube-shi, Yamaguchi, Japan | |
| Kyushu University Hospital Respiratory Medicine | Terminated |
| Fukuoka, Japan | |
| National Kyushu Cancer Center/Department of Thoracic Oncology | Active, not recruiting |
| Fukuoka, Japan | |
| The Cancer Institute Hospital of JFCR | Active, not recruiting |
| Koto-ku, Tokyo, Japan | |
| Korea, Republic of | |
| Asan Medical Center/Division of Oncology, Department of Internal Medicine | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Luxembourg | |
| Centre Hospitalier de Luxembourg | Recruiting |
| Luxembourg, Luxembourg, 1210 | |
| Mexico | |
| Instituto Nacional de Cancerologia | Recruiting |
| Mexico, D.f., Mexico, 14080 | |
| Netherlands | |
| Vrije Universiteit Medical Centre | Recruiting |
| Amsterdam, Netherlands, 1081 HV | |
| Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose | Recruiting |
| Maastricht, Netherlands, 6229 HX | |
| Jeroen Bosch Ziekenhuis, locatie Groot Ziekengasthuis | Recruiting |
| s-Hertogenbosch, Netherlands, 5223 GZ | |
| Norway | |
| Oslo universitetssykehus HF - Radiumhospitalet | Recruiting |
| Oslo, Norway, 0310 | |
| Peru | |
| Clinica Anglo Americana/Centro de Investigacion Oncologia CAA | Recruiting |
| San Isidro, Lima, Peru, 27 | |
| Portugal | |
| Centro Hospitalar de Coimbra | Recruiting |
| Coimbra, Portugal, 3041-801 | |
| Centro Hospitalar Lisboa Norte, EPE. | Recruiting |
| Lisboa, Portugal, 1769-001 | |
| Instituto Portugu�de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E. | Recruiting |
| Lisboa, Portugal, 1099-023 | |
| Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | Recruiting |
| Vila Nova de Gaia, Portugal, 4434-502 | |
| Russian Federation | |
| Russian Oncological Research Center N.N. Blokhin, Chemotherapy Department | Recruiting |
| Moscow, Russian Federation, 115478 | |
| Research Institute of Pulmonology | Recruiting |
| Saint-Petersburg, Russian Federation, 197089 | |
| St.-Petersburg State Medical University I.P.Pavlov of Roszdrav | Recruiting |
| Saint-Petersburg, Russian Federation, 197022 | |
| City Clinical Oncology Dispensary | Recruiting |
| Saint-Petersburg, Russian Federation, 197022 | |
| City Clinical Oncology Dispensary | Recruiting |
| Saint-Petersburg, Russian Federation, 198255 | |
| Russian Scientific Center of Radiology and Surgical Technologies | Recruiting |
| Saint-Petersburg, Russian Federation, 197758 | |
| Samara Regional Clinical Oncology Dispensary | Terminated |
| Samara, Russian Federation, 443031 | |
| Singapore | |
| National Cancer Centre | Recruiting |
| Singapore, Singapore, 169610 | |
| Parkway Cancer Centre | Recruiting |
| Singapore, Singapore, 228510 | |
| OncoCare Cancer Centre | Active, not recruiting |
| Singapore, Singapore, 258499 | |
| National University Hospital | Recruiting |
| Singapore, Singapore, 119074 | |
| South Africa | |
| Rondebosch Oncology Centre, Rondebosch Medical Centre | Terminated |
| Cape Town, South Africa, 7700 | |
| University of Witwatersrand Oncology | Recruiting |
| Parktown, South Africa, 2193 | |
| Spain | |
| Hospital General Universitario de Elche | Recruiting |
| Elche, Alicante, Spain, 03203 | |
| Hospital Clinic I Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Hospital General Universitari Vall D'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| Hospital Universitario Insular de Gran Canaria | Recruiting |
| Las Palmas de Gran Canaria, Spain, 35016 | |
| Hospital Doce de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Hospital Ramon Y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Hospital Universitario Virgen de La Victoria | Recruiting |
| Malaga, Spain, 29010 | |
| Hospital Universitario Virgen Macarena | Recruiting |
| Sevilla, Spain, 41009 | |
| Hospital Clinico Universitario Lozano Blesa | Recruiting |
| Zaragoza, Spain, 50009 | |
| Switzerland | |
| Kantonsspital Basel | Recruiting |
| Basel, Switzerland, CH-4031 | |
| Luzerner Kantonsspital | Recruiting |
| Luzern, Switzerland, 6000 | |
| Kantonsspital | Recruiting |
| Winterthur, Switzerland, CH-8401 | |
| Taiwan | |
| Chang Gung Medical Foundation, Kaohsiung Branch | Recruiting |
| Kaohsiung Hsien, Taiwan, 833 | |
| China Medical University Hospital | Recruiting |
| Taichung, Taiwan, 404 | |
| Taichung Veterans General Hospital, Comprehensive Cancer Center | Recruiting |
| Taichung, Taiwan, 40705 | |
| Chang Gung Medical Foundation, LinKou Branch | Recruiting |
| Taoyuan, Taiwan, 333 | |
| Ukraine | |
| Department of Oncology and Medical Radiology of SI "Dnipropetrovsk State Medical Academy of | Recruiting |
| Dnipropetrovsk, Ukraine, 49102 | |
| Department of Oncology and Medical Radiology of Dnipropetrovsk State Medical Academy | Recruiting |
| Dnipropetrovsk, Ukraine, 49102 | |
| Kyiv City Clinical Oncologic Center/Department of Chemotherapy | Recruiting |
| Kyiv, Ukraine, 03115 | |
| Lviv State Oncologic Regional Treatment and Diagnostic Center | Recruiting |
| Lviv, Ukraine, 79031 | |
| United Kingdom | |
| Lister Hospital | Recruiting |
| Stevenage, Hertfordshire, United Kingdom, SG1 4AB | |
| Mount Vernon Hospital, Mount Vernon Cancer Centre | Recruiting |
| Northwood, Middlesex, United Kingdom, HA6 2RN | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, United Kingdom, AB25 2ZN | |
| Queen Elizabeth Hospital | Not yet recruiting |
| Birmingham, United Kingdom, B15 2TH | |
| Addenbrooke's Hospital, Oncology Centre | Recruiting |
| Cambridge, United Kingdom, CB2 0QQ | |
| The Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Queen Elizabeth II Hospital | Recruiting |
| Hertfordshire, United Kingdom, AL7 4HQ | |
| Christie Hospital NHS Trust, Department of Medical Oncology | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
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: | NCT01154140 History of Changes |
| Other Study ID Numbers: | A8081014 |
| Study First Received: | June 29, 2010 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
open label randomized Phase 3 first line treatment non squamous lung cancer ALK translocation event positive |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Pemetrexed Cisplatin Carboplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on June 17, 2013