Carcinoma, Non-Small-Cell Lung Clinical Trial
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
| Verified date | February 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1069 |
| Est. completion date | December 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital, Department of Medical Oncology | Adelaide | South Australia |
| Australia | Chris O'Brien Lifehouse | Camperdown | New South Wales |
| Australia | Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology | East Melbourne | Victoria |
| Australia | Department of Medical Oncology | Nedlands | Western Australia |
| Brazil | Fundacao Pio XII Hospital de Cancer de Barretos | Barretos | SP |
| Brazil | Associacao Hospital de Caridade de Ijui | Ijui | RS |
| Brazil | Fundacao Hospital Amaral Carvalho | Jau | Sao Paulo |
| Brazil | Hospital Sao Lucas da PUCRS | Porto Alegre | RS |
| Brazil | Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
| Brazil | Instituto Nacional do Câncer - INCA | Rio de Janeiro | RJ |
| Brazil | Nucleo de Oncologia da Bahia | Salvador | BA |
| Brazil | Fundacao Antonio Prudente | Sao Paulo | SP |
| Brazil | Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP | Sao Paulo | SP |
| Bulgaria | MBAL Voennomeditsinska Academia, MMA HAT Sofia | Sofia | |
| Bulgaria | Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya | Sofia | |
| Bulgaria | UMHAT Tsaritsa Yoanna - ISUL | Sofia | |
| Bulgaria | MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi | Varna | |
| Canada | Alberta Health Services, Holy Cross Site | Calgary | Alberta |
| Canada | Office of Dr. John McWhae | Calgary | Alberta |
| Canada | Tom Baker Cancer Centre | Calgary | Alberta |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Dr. Georges-L. Dumont Regional Hospital | Moncton | New Brunswick |
| Canada | Dr. Leon Richard Oncology Centre | Moncton | New Brunswick |
| Canada | Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec |
| Canada | Jewish General Hospsital | Montreal | Quebec |
| Canada | Montreal General Hospital | Montreal | Quebec |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Canada | St. Mary's Hospital Center | Montreal | Quebec |
| Canada | Dr. Dana Blakolmer and Associates | Oshawa | Ontario |
| Canada | RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa | Oshawa | Ontario |
| Canada | The Ottawa Hospital Cancer Center | Ottawa | Ontario |
| China | 307 Hospital of PLA | Beijing | |
| China | Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department | Beijing | |
| China | Guangdong General Hospital | Guangzhou | |
| China | SUN Yat-Sen University Cancer Center | Guangzhou | Guangdong |
| China | Nanjing Bayi Hospital | Nanjing | Jiangsu |
| China | Shanghai Chest Hospital | Shanghai | |
| China | Shanghai Chest Hospital/Department of Pulmonary Medicine | Shanghai | |
| China | Shanghai Pulmonary Hospital | Shanghai | |
| China | Zhongshan Hospital Fudan University / Respiratory Department | Shanghai | |
| France | Centre Francois Baclesse | Caen Cedex 05 | |
| France | Centre Georges-François Leclerc | Dijon | |
| France | Hopital Albert Michallon | Grenoble Cedex 09 | |
| France | APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques | Marseille Cedex 20 | |
| France | Centre Antoine Lacassagne | NICE Cedex 2 | |
| France | Hospital Cochin | Paris | |
| France | Hopital Tenon | Paris cedex 20 | |
| France | Centre Rene Gauducheau / Service d'Oncologie Medicale | St Herblain Cedex | |
| France | Institut Gustave Roussy | Villejuif | |
| Germany | Universitaetsklinik Carl-Gustav-Carus Dresden | Dresden | |
| Germany | Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung | Essen | |
| Germany | Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie | Grosshansdorf | |
| Germany | Ambulantes Krebszentrum Hamburg | Hamburg | |
| Germany | Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren | Heidelberg | |
| Germany | St. Vincentius-Kliniken Karlsruhe | Karlsruhe | |
| Germany | Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin | Koeln | |
| Germany | Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie | Muenchen | |
| Germany | Pius-Hospital Oldenburg | Oldenburg | |
| Germany | HSK Dr.- Horst-Schmidt-Kliniken GmbH, Haematologie/Onkologie, Innere Medizin III | Wiesbaden | |
| Greece | General Hospital of Chest Diseases of Athens "Sotiria" | Athens | |
| Greece | General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department | Exohi | Thessaloniki |
| Greece | University General Hospital of Heraklion/ Department of Clinical Oncology | Heraklion | Crete |
| 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 | |
| Hungary | Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia | Budapest | |
| Hungary | Semmelweis Egyetem Pulmonologia Intezet | Budapest | |
| Hungary | Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika | Debrecen | |
| Hungary | Veszprem Megyei Onkormanyzat Tudogyogyintezete | Farkasgyepu | |
| Hungary | Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly | Szekesfehervar | |
| Hungary | Pest Megyei Tudogyogyintezet, III. Osztaly | Torokbalint | |
| Ireland | Department of Medical Oncology | Dublin 8 | |
| Ireland | Department of Medical Oncology | Galway | |
| Italy | Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera | Avellino | |
| Italy | S.C. Oncologia Medica | Firenze | |
| Italy | Oncologia Medica A | Genova | |
| Italy | Ospedale Versilia, Oncologia Medica | Lido di Camaiore (LU) | |
| Italy | Ospedale San Luca | Lucca | |
| Italy | Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative | Milano | |
| Italy | Istituto Europeo di Oncologia | Milano | |
| Italy | Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk | Milano | |
| Italy | Nuovo Ospedale San Gerardo | Monza | |
| Italy | Azienda Ospedaliera Universitaria San Luigi Gonzaga | Orbassano (TO) | |
| Italy | SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia | Perugia | |
| Italy | Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani | Roma | |
| Italy | Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette | Torino | |
| Japan | Hyogo Cancer Center | Akashi | Hyogo |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo |
| Japan | National Kyushu Cancer Center/Department of Thoracic Oncology | Fukuoka | |
| Japan | National Cancer Center Hospital East | Kashiwa | Chiba |
| Japan | Aichi cancer center central hospital | Nagoya | Aichi |
| Japan | Okayama University Hospital / Department of Respiratory Medicine and Allergy | Okayama | |
| Japan | Kinki University Hospital | Osakasayama-shi | Osaka |
| Japan | National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido |
| Japan | Shizuoka Cancer Center | Sunto-gun | Shizuoka |
| Japan | The Cancer Institute Hospital of JFCR | Tokyo | |
| Korea, Republic of | National Cancer Center, Center for Lung Cancer | Gyeonggi-do | |
| Korea, Republic of | Samsung Medical Center, Sungkyunkwan Univ School of Medicine | Seoul | |
| Korea, Republic of | Seoul National University Hospital / Department of Internal Medicine | Seoul | |
| Netherlands | Universitair Medisch Centrum Groningen / Afdeling Inwendige Geneeskunde | Groningen | |
| Poland | Klinika Onkologii i Radioterapii | Gdansk | |
| Poland | Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc | Olsztyn | |
| Poland | Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii | Poznan | |
| Poland | Zaklad Diagnostyki Obrazowej | Poznan | |
| Russian Federation | Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic | Kazan | |
| Russian Federation | State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS" | Moscow | |
| Russian Federation | City Clinical Oncology Dispensary | Saint-Petersburg | |
| Russian Federation | Research Institute of Pulmonology | Saint-Petersburg | |
| Russian Federation | Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav | Saint-Petersburg | |
| Russian Federation | City Clinical Oncology Dispensary | St. Petersburg | |
| Spain | Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil) | A Coruña | |
| Spain | Hospital Universitari Germans Trias I Pujol | Badalona | Barcelona |
| Spain | Hospital Del Mar | Barcelona | |
| Spain | Hospital General Universitari Vall D´Hebron | Barcelona | |
| Spain | Institut Catala Doncologia - Hospital Duran I Reynals | L'hospitalet de Llobregat | Barcelona |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
| Spain | Hospital de Navarra | Pamplona | |
| Spain | Consorcio Hospitalario Parc Tauli | Sabadell | Barcelona |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Sweden | Karolinska Universitetssjukhuset, Onkologiska kliniken | Stockholm | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | National Taiwan University Hospital, Department of Internal Medicine | Taipei | |
| Taiwan | Taipei Veterans General Hospital, Chest Department | Taipei | |
| United Kingdom | Nuffield Health Wessex Hospital | Eastleigh | |
| United Kingdom | Cancer and Haematology Centre, | Headington | Oxford |
| United Kingdom | Department of Oncology | London | |
| United Kingdom | Kings College London at Guy's Hospital | London | |
| United Kingdom | Royal Marsden Hospital | London | |
| United Kingdom | Christie Hospital NHS Trust, Department of Medical Oncology | Manchester | |
| United Kingdom | Somers Cancer Research Building, M824 | Southampton | |
| United Kingdom | Royal Marsden Hospital | Sutton | Surrey |
| United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
| United States | University of New Mexico Eye Clinic | Albuquerque | New Mexico |
| United States | Emory Clinic | Atlanta | Georgia |
| United States | Emory University Clinic | Atlanta | Georgia |
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | Emory University Hospital Midtown | Atlanta | Georgia |
| United States | Georgia Cancer Specialists - Administrative Annex | Atlanta | Georgia |
| United States | Winship Cancer Institution | Atlanta | Georgia |
| United States | MCG Health Cancer Center Pharmacy | Augusta | Georgia |
| United States | MCG Health System Pharmacy (Drug Shipment Only) | Augusta | Georgia |
| United States | Medical College of Georgia | Augusta | Georgia |
| United States | DRUG SHIPMENT: University of Colorado Cancer Center | Aurora | Colorado |
| United States | Rocky Mountain Lions Eye Institute | Aurora | Colorado |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | The Harry and Jeanette Cancer Research Building | Baltimore | Maryland |
| United States | National Institutes of Health National Cancer Institute | Bethesda | Maryland |
| United States | Tower Cancer Research Foundation | Beverly Hills | California |
| United States | Tower Hematology Oncology Medical Group | Beverly Hills | California |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Beth Isreal Deaconess Medical Center | Boston | Massachusetts |
| United States | Beth Isreal Deaconess Medical Center, Pharmacy FD B18 | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute/Pharmacy | Boston | Massachusetts |
| United States | Massachusette General Hospital | Boston | Massachusetts |
| United States | Massachussetts General Hospital | Boston | Massachusetts |
| United States | All shipment of study drug should go to: | Chapel Hill | North Carolina |
| United States | UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina - Hollings Cancer Center | Charleston | South Carolina |
| United States | Presbyterian Hospital Cancer Center | Charlotte | North Carolina |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | James Care in Kenny | Columbus | Ohio |
| United States | The Ohio State University Hospital East | Columbus | Ohio |
| United States | The Ohio State University James Cancer Hospital and Solove Research Institute | Columbus | Ohio |
| United States | Siteman Cancer Center- West County | Creve Coeur | Missouri |
| United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | University of Texas Southwestern University Hospital - St. Paul | Dallas | Texas |
| United States | University of Texas Southwestern University Hospital - Zale Lipshy | Dallas | Texas |
| United States | Georgia Cancer Specialists-Stemmer | Decatur | Georgia |
| United States | Kaiser Permanente | Denver | Colorado |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | Tennessee Oncology, PLLC | Dickson | Tennessee |
| United States | Pharma Resource | East Providence | Rhode Island |
| United States | Vincent Armenio, MD | East Providence | Rhode Island |
| United States | Karmanos Cancer lnstitute at Farmington Hllls | Farmington Hills | Michigan |
| United States | Michael and Dianne Bienes Cancer Center, Holy Cross Hospital | Fort Lauderdale | Florida |
| United States | Tennessee Oncology, PLLC | Franklin | Tennessee |
| United States | Tennessee Oncology, PLLC | Gallatin | Tennessee |
| United States | Ingalls Memorial Hospital | Harvey | Illinois |
| United States | Ingalls Memorial Hospital (Drug Shipment Only) | Harvey | Illinois |
| United States | Monroe Medical Associates | Harvey | Illinois |
| United States | Tennessee Oncology, PLLC | Hermitage | Tennessee |
| United States | Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute | Hershey | Pennsylvania |
| United States | Memorial Cancer Institute | Hollywood | Florida |
| United States | Hawaii Medical Center East | Honolulu | Hawaii |
| United States | OnCare Hawaii, Inc. | Honolulu | Hawaii |
| United States | University of Hawaii - Cancer Research Center of Hawaii | Honolulu | Hawaii |
| United States | The University of Texas | Houston | Texas |
| United States | Presbyterian Hospital Huntersville | Huntersville | North Carolina |
| United States | Southern Oncology Specialists | Huntersville | North Carolina |
| United States | Indiana University Hospital Clarian Health | Indianapolis | Indiana |
| United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
| United States | Ship drug to: Investigational Drug Services | Indianapolis | Indiana |
| United States | Wishard Memorial Hospital | Indianapolis | Indiana |
| United States | Springmill Medical Clinic | Indianopolis | Indiana |
| United States | Moores UCSD Cancer Center | La Jolla | California |
| United States | UCSD Medical Center - La Jolla | La Jolla | California |
| United States | Kaiser Permanente | Lafayette | Colorado |
| United States | NSLIJ Health System/Monter Cancer Center | Lake Success | New York |
| United States | Cancer Center of South Florida Foundation, Inc. | Lake Worth | Florida |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Tennessee Oncology, PLLC | Lebanon | Tennessee |
| United States | University of Arkansas for Medical Research | Little Rock | Arkansas |
| United States | Drug Shipping Address [IRB number 09-11-100]: Ronald Reagen University of California-Los Angeles | Los Angeles | California |
| United States | Ronald Reagen University of California-Los Angeles Medical Center | Los Angeles | California |
| United States | UCLA Opthalmic Oncology Center | Los Angeles | California |
| United States | University of California-Los Angeles | Los Angeles | California |
| United States | Georgia Cancer Specialists-Macon | Macon | Georgia |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Georgia Cancer Specialists-Kennestone | Marietta | Georgia |
| United States | Presbyterian Hospital Matthews | Matthews | North Carolina |
| United States | Monroe Medical Associates | Munster | Indiana |
| United States | The Community Hospital | Munster | Indiana |
| United States | Tennessee Oncology, PLLC | Murfreesboro | Tennessee |
| United States | Sarah Cannon Research Institute (Administration) | Nashville | Tennessee |
| United States | Sarah Cannon Research Institute (Pharmacy) | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | The Vanderbilt Chemo Clinic | Nashville | Tennessee |
| United States | Vanderbilt Cancer Clinic | Nashville | Tennessee |
| United States | Clinical Trial Office | New Haven | Connecticut |
| United States | Drug Shipping for Yale; C/O Thomas Ferenez, RPh, BCOP | New Haven | Connecticut |
| United States | Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut |
| United States | Yale Cancer Center | New Haven | Connecticut |
| United States | Long Island Jewish Medical Center | New Hyde Park | New York |
| United States | Columbia University Medical Center | New York | New York |
| United States | Memorial Sloan - Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavillion | New York | New York |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians | Oneida | New York |
| United States | Ship Drug To : Lorene Kong- University of California, Irvine-Pharmacy | Orange | California |
| United States | University of California, Irvine-Medical Center | Orange | California |
| United States | Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians | Oswego | New York |
| United States | Stanford University-Cancer Center | Palo Alto | California |
| United States | Memorial Cancer Center (West) | Pembroke Pines | Florida |
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | UC Davis Cancer Center | Sacramento | California |
| United States | University of California Davis Medical Center | Sacramento | California |
| United States | UCSD Medical Center - Hillcrest | San Diego | California |
| United States | Georgia Cancer Specialists-Northside | Sandy Springs | Georgia |
| United States | Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory | Santa Monica | California |
| United States | UCLA Hematology Oncology-Santa Monica | Santa Monica | California |
| United States | University of California-Los Angeles | Santa Monica | California |
| United States | Redwood Regional Medical Group Inc | Santa Rosa | California |
| United States | Lisa Nakatsu, RPh (Drug Shipment Address) | Seattle | Washington |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | Tennessee Oncology, PLLC | Smyrna | Tennessee |
| United States | Barnes-Jewish Hospital | St. Louis | Missouri |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| United States | Siteman Cancer Center | St. Peters | Missouri |
| United States | Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians | Syracuse | New York |
| United States | SUNY Upstate Medical University, Regional Oncology Center | Syracuse | New York |
| United States | H Lee Moffitt Cancer Center & Research Institute | Tampa | Florida |
| United States | Monroe Medical Associates | Tinley Park | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate | 30 months | No | |
| Primary | Type, incidence, severity, seriousness and relationship to study medication of adverse events and laboratory test abnormalities | 30 months | Yes | |
| Secondary | Duration of Response | 30 months | No | |
| Secondary | Disease Control Rate | 30 months | No | |
| Secondary | Overall Survival | 30 months | Yes | |
| Secondary | Patient reported symptoms of lung cancer and health-related quality of life | 30 months | Yes | |
| Secondary | Plasma concentrations of PF-02341066 | 30 months | No | |
| Secondary | Types of EML4-ALK fusion variants and ALK gene expression | 30 months | No | |
| Secondary | Protein expression of identified biomarkers in serial tumor samples (when available) | 30 months | No | |
| Secondary | Progression Free Survival | 30 months | Yes | |
| Secondary | Time to Tumor Response | 30 months | No | |
| Secondary | QTc | 30 months | Yes | |
| Secondary | genotypes of alleles possibly associated with adverse hepatic or renal drug reactions | 30 months | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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