Spots Global Cancer Trial Database for Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
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Trial Identification
Brief Title: Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
Official Title: The NEMO Trial (NRAS Melanoma and MEK Inhibitor):A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma
Study ID: NCT01763164
Study Description
Brief Summary: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, Fayetteville, Arkansas, United States
Highlands Oncology Group, Rogers, Arkansas, United States
Florida Cancer Specialists, Altamonte Springs, Florida, United States
Florida Cancer Specialists, Bonita Springs, Florida, United States
Florida Cancer Specialists, Bradenton, Florida, United States
Florida Cancer Specialists, Brandon, Florida, United States
Florida Cancer Specialists, Cape Coral, Florida, United States
Florida Cancer Specialists, Clearwater, Florida, United States
Florida Cancer Specialists, Clearwater, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists, Gainesville, Florida, United States
Florida Cancer Specialists, Hudson, Florida, United States
Florida Cancer Specialists, Inverness, Florida, United States
Florida Cancer Specialists, Largo, Florida, United States
Florida Cancer Specialists, Largo, Florida, United States
Florida Cancer Specialists, Naples, Florida, United States
Florida Cancer Specialists, Naples, Florida, United States
Florida Cancer Specialists, New Port Richey, Florida, United States
Florida Cancer Specialists, Orange City, Florida, United States
Florida Cancer Specialists, Orlando, Florida, United States
Florida Cancer Specialists, Port Charlotte, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Florida Cancer Specialists, Spring Hill, Florida, United States
Florida Cancer Specialists, Tampa, Florida, United States
Florida Cancer Specialists, Tampa, Florida, United States
Florida Cancer Specialists, Tavares, Florida, United States
Florida Cancer Specialists, Venice, Florida, United States
Florida Cancer Specialists, Venice, Florida, United States
Oncology Specialists, SC, Niles, Illinois, United States
Oncology Specialists, SC, Park Ridge, Illinois, United States
Goshen Center For Cancer Care, Goshen, Indiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Harry and Jeannette Weinberg Cancer Institute @Franklin Square, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Kresge Eye Institute, Bingham Farms, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Kresge Eye Institute, Detroit, Michigan, United States
Karmanos Cancer Institute of Farmington Hills, Farmington Hills, Michigan, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Cooper University Hospital, Voorhees, New Jersey, United States
The Ohio State University James Cancer Hospital, Columbus, Ohio, United States
The Ohio State University Martha Morehouse Medical Plaza, Columbus, Ohio, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Kaiser Permanente Northwest Region Oncology/Hematology, Portland, Oregon, United States
OHSU Center for Health and Healing, Portland, Oregon, United States
OHSU, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Cancer Center Associates - Medical Oncology, Allentown, Pennsylvania, United States
St. Luke's Cancer Center - Allentown Campus, Allentown, Pennsylvania, United States
St. Luke's Hospital - Allentown Campus, Allentown, Pennsylvania, United States
Cancer Center Associates - Medical Oncology, Bethlehem, Pennsylvania, United States
St. Luke's University Hospital - Bethlehem Campus, Bethlehem, Pennsylvania, United States
St. Luke's Cancer Center - Anderson Campus, Easton, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Thomas Jefferson Medical Oncology, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
St. Luke's Hospital - Quakertown Campus, Quakertown, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology-Austin Central, Austin, Texas, United States
Elliot J. Ginchansky, MD, PA, Dallas, Texas, United States
Dennis B. Kay, Dallas, Texas, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern University Hospital- St. Paul, Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States
UT Southwestern University Hospital - Zale Lipshy, Dallas, Texas, United States
US Oncology, Fort Worth, Texas, United States
US Oncology, The Woodlands, Texas, United States
Sanatorio de La Providencia, Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina
Centro de Investigación Clínica ? Clínica Viedma, Viedma, RÍO Negro, Argentina
Centro Oncologico de Rosario, Rosario, Santa FE, Argentina
Fundacion CIDEA, Buenos Aires, , Argentina
Chris O'Brien Lifehouse Hospital, Camperdown, New South Wales, Australia
Lake Macquarie Private Hospital, Gateshead, New South Wales, Australia
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
LKH-Universitätsklinikum Klinikum Graz, Graz, Steiermark, Austria
Universitätsklinikum Innsbruck, Innsbruck, Tirol, Austria
Salzburger Landeskliniken, Salzburg, , Austria
Allgemeines Krankenhaus der Stadt Wien, Vienna, , Austria
Sint-Augustinuskliniek, Wilrijk, Antwerpen, Belgium
UZ Gasthuisberg, Leuven, , Belgium
CHU Sart Tilman, Liege, , Belgium
Hospital de Clinicas de Passo Fundo, Passo Fundo, RIO Grande DO SUL, Brazil
Hospital Moinhos de Vento, Porto Alegre, RIO Grande DO SUL, Brazil
Hospital Moinhos de Vento, Porto Alegre, RIO Grande DO SUL, Brazil
INCA Instituto Nacional de Cancer, Rio de Janeiro, , Brazil
Hospital São José, Sao Paulo, , Brazil
Alberta Health Services - Cross Cancer Institute, Edmonton, Alberta, Canada
London Regional Cancer Program, London, Ontario, Canada
Sunnybrook Research Institute Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
McGill University Health Center / Royal Victoria Hospital, Montreal, Quebec, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec, Quebec, , Canada
Mou/Mmci - Ppds, Brno, Jihomoravský KRAJ, Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Vseobecna Fakultni Nemocnice V Praze, Praha 2, , Czechia
CHU Angers, Angers, Maine-et-loire, France
CHRU de Lille - Hôpital Huriet, Lille, Nord, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes, Lyon, Rhône, France
Hôpital Saint-André, Bordeaux, , France
Centre Hospitalier Universitaire Ambroise Pare, Boulogne Billancourt, , France
Centre Hospitalier Le Mans, Le Mans, , France
Hopitaux de La Timone, Marseille, , France
Groupe Hospitalier Archet I Et II, Nice, , France
Hôpital Saint Louis, Paris, , France
Service de PneumologieCHU Lyon Sud, Pierre Benite, , France
Hôpital Robert Debré, Reims, , France
Centre Hospitalier Universitaire Hopitaux de Rouen, Rouen, , France
Universitaetsklinikum Freiburg, Freiburg im Breisgau, Baden-württemberg, Germany
Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim, Baden-württemberg, Germany
LMU Klinikum der Universität München, München, Bayern, Germany
University Clinic Regensburg - PPDS, Regensburg, Bayern, Germany
Universitätsklinikum Würzburg, Würzburg, Bayern, Germany
Institut für Diagnostische und Interventionelle Radiologie Frankfurt, Frankfurt, Hessen, Germany
Universitätsklinikum Frankfurt, Frankfurt, Hessen, Germany
Elben Klinken Stade Buxtehude, Buxtehude, Niedersachsen, Germany
Johannes Wesling Klinikum Minden, Minden, Nordrhein-westfalen, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH, Quedlinburg, Sachsen-anhalt, Germany
Universitatsklinikum Leipzig, Leipzig, Sachsen, Germany
Charite Campus Mitte, Berlin, Schleswig-holstein, Germany
Helios Klinikum Erfurt, Erfurt, Thüringen, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Universitätsklinikum Essen, Essen, , Germany
SRH Wald-Klinikum Gera GmbH, Gera, , Germany
Medizinische Hochschule Hannover (Hannover Medical School), Hannover, , Germany
University Clinic Heidelberg - PPDS, Heidelberg, , Germany
Universitatsklinikum Schleswig-Holstein, Kiel, , Germany
Uniklinik Köln, Koeln, , Germany
Universitatsklinikum Schleswig-Holstein, Lübeck, , Germany
Fachklinik Hornheide, Münster, , Germany
Klinikum Nuernberg Nord, Nürnberg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universit*ätsklinikum Ulm, Ulm, , Germany
Laiko General Hospital of Athens, Athens, , Greece
Magyar Honvédség Egészségügyi Központ, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Rambam Medical Center - PPDS, Haifa, , Israel
Hadassah Medical Center - PPDS, Jerusalem, , Israel
Sheba Medical Center - PPDS, Ramat Gan, , Israel
AOU dell'Università degli Studi della Campania Luigi Vanvitelli, Napoli, Campania, Italy
Istituto Dermopatico dell'Immacolata IRCCS, Roma, Lazio, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia, Brescia, Lombardia, Italy
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale, Napoli, Naples, Italy
Istituto Oncologico Veneto - I.R.C.C.S., Padova, Veneto, Italy
IRCCS Giovanni Paolo II Istituto Oncologico, Bari, , Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
IRCCS Az. Osp. Universitaria San Martino- IST, Genova, , Italy
Ospedale San Raffaele S.r.l. - PPDS, Milano, , Italy
Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano, Milano, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Azienza Ospedaliera Universitaria Senese, Siena, , Italy
A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro, Torino, , Italy
Shinshu University Hospital, Matsumoto, Nagano, Japan
National Cancer Center Hospital, Chuo-ku, , Japan
Kansai Medical University Hospital, Hirakata-city, , Japan
Asan Medical Center - PPDS, Seoul, , Korea, Republic of
Samsung Medical Center - PPDS, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS, Seoul, , Korea, Republic of
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, Noord-holland, Netherlands
Leids Universitair Medisch Centrum, Leiden, Zuid-holland, Netherlands
Isala Klinieken, Zwolle, , Netherlands
Centrum Medyczne MAVIT Sp. z o.o., Warszawa, Mazowieckie, Poland
Lux Med, Warszawa, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, Lisboa, Portugal
Hospital Garcia de Orta*E.P.E., Almada, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto, , Portugal
Russian Oncology Research Center n a N N Blokhin, Moscow, , Russian Federation
Ryazan Regional Clinical Oncology Dispensary, Ryazan, , Russian Federation
Scientific Research Institute of Oncology n.a. N.N. Petrov, St. Petersburg, , Russian Federation
Narodny onkologicky ustav, Bratislava, , Slovakia
University of The Free State, Bloemfontein, FREE State, South Africa
Sandton Oncology Medical Group, Johannesburg, Gauteng, South Africa
Sandton Oncology Medical Research, Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital, Pretoria, Gauteng, South Africa
Mary Potter Oncology Centre, Pretoria, Gauteng, South Africa
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Regional Universitario de Malaga Hospital General, Malaga, Málaga, Spain
Clinica Universidad Navarra, Pamplona, Navarra, Spain
Hospital Universitario Vall d'Hebrón - PPDS, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
Complejo Hospitalario Universitario Insular - Materno Infantil, Gran Canaria, , Spain
Hospital Universitario A Coruña, La Coruna, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Virgen de La Salud, Toledo, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
Skanes Universitetssjukhus Lund, Lund, Skane LAN, Sweden
Skanes Universitetssjukhus Lund, Lund, , Sweden
Universitätsspital Zürich, Zurich, Zürich (DE), Switzerland
Hôpitaux Universitaires de Genève, Genève, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Ege University Medical Faculty, Bornova, Izmir, Turkey
Adana Ba?kent Hastanesi K??la Yerle?kesi, Adana, , Turkey
Hacettepe University Medical Faculty, Ankara, , Turkey
Baskent University Medical Faculty Ankara Hospital, Ankara, , Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital, Istanbul, , Turkey
Bristol Haematology and Oncology Centre, Bristol, Bristol, CITY OF, United Kingdom
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
The Royal Sussex County Hospital, Brighton, EAST Sussex, United Kingdom
Broomfield Hospital, Chelmsford, Essex, United Kingdom
Singleton Hospital - PPDS, Swansea, Glamorgan, United Kingdom
Royal Preston Hospital, Preston, Lancashire, United Kingdom
Royal Marsden Hospital - Surrey, London, London, CITY OF, United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
St James s Institute of Clinical Oncology, Leeds, , United Kingdom
Clatterbridge Hospital, Wirral, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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