Spots Global Cancer Trial Database for A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
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Trial Identification
Brief Title: A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
Official Title: A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
Study ID: NCT01798485
Study Description
Brief Summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.
Detailed Description: Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed. Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility. The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates PC- NAHOA, Flagstaff, Arizona, United States
Arizona Oncology Associates, PC- NAHOA, Prescott Valley, Arizona, United States
Northern Arizona Hematology & Oncology Associates, Sedona, Arizona, United States
Arizona Clinical Research Center, Inc., Tucson, Arizona, United States
Pacific Cancer Medical Center, Inc, Anaheim, California, United States
Comprehensive Blood & Cancer Center, Bakersfield, California, United States
City of Hope Comprehensive Breast Cancer Center, Duarte, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Loma Linda University Cancer Center, Loma Linda, California, United States
VA Greater Los Angeles Healthcare System, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
St. Joseph Hospital, Center for Cancer Prevention and Treatment, Orange, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
UC Davis Medical Center - UC Davis Comprehensive Cancer, Sacramento, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States
City of Hope- South Pasadena, South Pasadena, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Eastern Connecticut Hematology Associates, Norwich, Connecticut, United States
Medical Oncology Hematology Consultants, PA, Newark, Delaware, United States
Lynn Cancer Institute Center for Hematology Oncology, Boca Raton, Florida, United States
Halifax Health - Medical Center, Daytona Beach, Florida, United States
University of Miami Health System Sylvester at Deerfield Beach, Deerfield Beach, Florida, United States
Memorial Regional Hospital, Hollywood, Florida, United States
Baptist Health Medical Group Oncology, LLC, Miami, Florida, United States
University of South Florida - H. Lee Moffitt, Tampa, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States
University Of Chicago Medical Center, Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C., Decatur, Illinois, United States
Saint Anthony Medical Center, Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc, Fort Wayne, Indiana, United States
AAMC Oncology and Hematology, Annapolis, Maryland, United States
The Center for Cancer and Blood Disorders (CCBD) - Bethesda, Bethesda, Maryland, United States
The John R Marsh Cancer Center, Hagerstown, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Luke's Hospital Duluth, Duluth, Minnesota, United States
Frauenshuh Cancer Center, Saint Louis Park, Minnesota, United States
St. Louis Cancer Care, LLP - North County, Bridgeton, Missouri, United States
Renown Regional Medical Center, Reno, Nevada, United States
Hackensack University Medical Center - John Theurer Cancer Center, Hackensack, New Jersey, United States
New Mexico Cancer Center, Albuquerque, New Mexico, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
Clinical Research Alliance, Lake Success, New York, United States
University Of North Carolina At Chapel Hill, Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
New Hanover Regional Medical Center - Zimmer Cancer Center, Wilmington, North Carolina, United States
Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
Tulsa Cancer Institute, PLLC, Tulsa, Oklahoma, United States
Kaiser Permanente Northwest, Portland, Oregon, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC, Sayre, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Prairie Lakes Healthcare System, Watertown, South Dakota, United States
Erlanger Institute for Clinical Research, Chattanooga, Tennessee, United States
Associates In Oncology and Hematology, Chattanooga, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Texas Oncology-Arlington North, Arlington, Texas, United States
Texas Oncology - Arlington South, Arlington, Texas, United States
Texas Oncology, P.A., Beaumont, Texas, United States
Texas Oncology, PA, Dallas, Texas, United States
Simmons Comprehensive Cancer Center, Dallas, Texas, United States
Houston Methodist Hospital Research Institute, Houston, Texas, United States
Millennium Oncology, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Cancer Care Centers Of South Texas, San Antonio, Texas, United States
Cancer Care Centers Of South Texas, San Antonio, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology - Sherman, Sherman, Texas, United States
Providence Regional Medical Center Everett, Everett, Washington, United States
Cancer Care Northwest, Spokane Valley, Washington, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Mary Babb Cancer Center, Morgantown, West Virginia, United States
Green Bay Oncology, Ltd. - St. Mary's Site, Green Bay, Wisconsin, United States
Green Bay Oncology, Green Bay, Wisconsin, United States
Landesklinikum Krems, Krems, Niederösterreich, Austria
Krankenhaus Der Barmherzigen Schwestern, Linz, Oberösterreich, Austria
Klinikum Wels-Grieskirchen, Wels, Oberösterreich, Austria
Bezirkskrankenhaus Kufstein [Onkologie], Kufstein, Tirol, Austria
Allgemeines Krankenhaus Linz, Linz, , Austria
Elisabeth Linz Hospital, Linz, , Austria
Otto Wagner Spital, Wien, , Austria
Sozialmedizinisches Zentrum Baumgartner Höhe, Wien, , Austria
AZ Sint-Maarten - Campus Leopoldstraat, Mechelen, Antwerpen, Belgium
Clinique Saint-Pierre Ottignies, Ottignies, Brabant Wallon, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame, Charleroi, Hainaut, Belgium
INDC Entité Jolimontoise - Polyclinique de Jolimont, Haine St. Paul, Hainaut, Belgium
CHU Dinant Godinne UCL Namur, Yvoir, Namur, Belgium
Algemeen Stedelijk Ziekenhuis - Campus Aalst, Roeselaere, West-Vlaanderen, Belgium
Cliniques Universitaire Saint-Luc, Bruxelles, , Belgium
CHR de la Citadelle - Site Citadelle, Liège, , Belgium
Clinical Centre Banja Luka, Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Center Tuzla, Tuzla, Tuzlanski kanton, Bosnia and Herzegovina
Clinical Hospital Mostar, Mostar, , Bosnia and Herzegovina
Clinical Center University of Sarajevo, Clinic of Oncology, Sarajevo, , Bosnia and Herzegovina
University Clinical Centre Sarajevo, Sarajevo, , Bosnia and Herzegovina
University Clinical Center Tuzla, Tuzla, , Bosnia and Herzegovina
Kantonalna bolnica Zenica, Zenica, , Bosnia and Herzegovina
Princess Margaret Hospital, Toronto, Ontario, Canada
Mc Gill University-MUHC, Montreal, Quebec, Canada
University Hospital Center Zagreb, Zagreb, Grad Zagreb, Croatia
Opca bolnica Pula, Pula, Istarska županija, Croatia
Fakultni nemocnice Olomouc, Olomouc, , Czech Republic
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czech Republic
Vseobecna fakultni nemocnice v Praze, Prague, , Czech Republic
Nemocnice Na Bulovce, Prague, , Czech Republic
CHI des Alpes du Sud, Gap, Hautes-Alpes, France
Centre D'Oncologie Du Pays Basque, Bayonne, Pyrénées-Atlantiques, France
Centre Hosptalier De Villefranche-Sur-Saone, Villefranche Sur Saone, Rhône, France
Chi creteil, Creteil, Val-de-Marne, France
Chu De Grenoble - Hopital Michallon, Grenoble, , France
Centre Léon Bérard, Lyon, , France
Groupe Hospitalier Cochin, Paris, , France
Centre Hospitalier Universitaire de Rennes - Hopital d, Rennes, , France
Hôpital Charles Nicolle, Rouen, , France
CHRU de Strasbourg, Strasbourg, , France
Universitätsklinikum Freiburg, Freiburg, Baden-Württemberg, Germany
Universiaetsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Schwarzwald-Baar-Klinikum, Villingen-Schwenningen, Baden-Württemberg, Germany
Asklepios Fachklinik München-Gauting, Gauting, Bayern, Germany
Klinikum Bogenhausen, Muenchen, Bayern, Germany
Gesundheitszentrum Wetterau, Bad Nauheim, Hessen, Germany
Johann Wolfgang Goethe University Clinic Frankfurt, Frankfurt, Hessen, Germany
Johann Wolfgang Goethe University Clinic Frankfurt, Frankfurt, Hessen, Germany
Klinikum Kassel, Kassel, Hessen, Germany
Kliniken der Stadt Köln gGmbH, Köln, Nordrhein-Westfalen, Germany
Universitaetsklinikum des Saarlandes, Homburg, Saarland, Germany
Universitätsklinikum Leipzig [Pneumologie], Leipzig, Sachsen, Germany
Pneumologisches Forschungsinstitut an der Lungenclinic Gross, Großhansdorf, Schleswig-Holstein, Germany
MVZ Äerzteforum Seestraße, Berlin, , Germany
Ev. Krankenhaus Bielefeld, Bielefeld, , Germany
Klinikum Frankfurt An Der Oder, Frankfurt/Oder, , Germany
Practice Laack, Hamburg, , Germany
Unikl. Schleswig-Holstein - Lübeck, Lübeck, , Germany
J. Gutenberg Uni.Mainz, Mainz, , Germany
Medizinische Fakultät Mannheim Uni Heidelberg, Mannheim, , Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie, Muenster, , Germany
Klinikum Offenbach GmbH, Offenbach, , Germany
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó, Deszk, Csongrád, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház, Székesfehérvár, Fejér, Hungary
Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Pest, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intézet, Budapest, , Hungary
Békés Megyei Pándy Kálmán Kórház, Gyula, , Hungary
CRU Hungary Kft., Miskolc, , Hungary
Irccs Irst, Meldola, Forli, Italy
Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo, Viterbo, Lazio, Italy
Azienda Ospedaliera San Gerardo, Monza, Lombardia, Italy
CRO, IRCCS, Istituto Nazionale Tumori, Aviano, Pordenone, Italy
Azienda Policlinico Umberto I, Rome, Roma, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna, Bologna, , Italy
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can, Genova, , Italy
Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a, Milano, , Italy
Iov-Irccs, Padova, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia, Universi, Perugia, , Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza, Piacenza, , Italy
Istituti Fisioterapici Ospitalieri Regina Elena, Roma, , Italy
Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona, Verona, , Italy
Ziekenhuis Assen, Assen, Drenthe, Netherlands
Ziekenhuis St Jansdal, Harderwijk, Gelderland, Netherlands
Gelre Ziekenhuis Zutphen, Zutphen, Gelderland, Netherlands
academisch ziekenhuis Maastricht, Maastricht, Limburg, Netherlands
Isala Klinieken Zwolle, Zwolle, Overijssel, Netherlands
Sint Antoniusziekenhuis, location Utrecht, Utrecht, , Netherlands
Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Lodz, Lodzkie, Poland
Medica Pro Familia Sp. z o.o. S.K.A., Krakow, Malopolskie, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock, Mazowieckie, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie, Warszawa, Mazowieckie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, Podlaskie, Poland
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego, Lomza, Podlaskie, Poland
Szpital Wojewodzki Zespolony, Elblag, Warminsko-mazurskie, Poland
NZOZ Med Polonia, Poznan, Wielkopolskie, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii, Poznan, Wielkopolskie, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Olsztyn, , Poland
Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach, Pilchowice, , Poland
Szpital Specjalistyczny, Prabuty, , Poland
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu", Bucharest, , Romania
Spitalul Universitar de Urgenta Bucuresti, Bucharest, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca, Cluj Napoca, , Romania
Medisprof, Cluj Napoca, , Romania
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca, Cluj-Napoca, , Romania
Centrul de Oncologie Sf. Nectarie, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Oncomed, Timisoara, , Romania
Synta Pharmaceuticals Investigational Site, Chelyabinsk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Ekaterinburg, , Russian Federation
Synta Pharmaceuticals Investigational Site, Ivanovo, , Russian Federation
Synta Pharmaceuticals Investigational Site, Izhevsk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Kemerovo, , Russian Federation
Synta Pharmaceuticals Investigational Site, Krasnoyarsk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Kursk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Lipetsk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Moscow, , Russian Federation
Synta Pharmaceuticals Investigational Site, Nizhny Novgorod, , Russian Federation
Synta Pharmaceuticals Investigational Site, Novosibirsk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Omsk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Orel, , Russian Federation
Synta Pharmaceuticals Investigational Site, Rostov-on-Don, , Russian Federation
Synta Pharmaceuticals Investigational Site, Samara, , Russian Federation
Synta Pharmaceuticals Investigational Site, Saransk, , Russian Federation
Synta Pharmaceuticals Investigational Site, Sochi, , Russian Federation
Synta Pharmaceuticals Investigational Site, St. Petersburg, , Russian Federation
Synta Pharmaceuticals Investigational Site, St. Petersburg, , Russian Federation
Synta Pharmaceuticals Investigational Site, St. Petersburg, , Russian Federation
Synta Pharmaceuticals Investigational Site, Stavropol, , Russian Federation
Synta Pharmaceuticals Investigational Site, Ufa, , Russian Federation
Synta Pharmaceuticals Investigational Site, Ufa, , Russian Federation
Clinical Centre of Serbia, Beograd, Belgrade, Serbia
Clinical Centre Nis, Nis, Nišavski okrug, Serbia
Institute for Oncology and Radiology of Serbia, Belgrade, , Serbia
Institute for pulmonary diseases of Vojvodine, Sremska Kamenica, , Serbia
Clinical Center Kragujevac, Kragujevac, Šumadijski okrug, Serbia
Univerzitetna klinika za pljucne bolesti in alergijo Golnik, Golnik, , Slovenia
Onkoloski institut Ljubljana, Ljubljana, , Slovenia
Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera, La Coruña, A Coruña, Spain
Synta Pharmaceuticals Investigational Site, Málaga, Andalucía, Spain
Synta Pharmaceuticals Investigational Site, Oviedo, Asturias, Spain
H. Son Llàtzer, Palma de Mallorca, Baleares, Spain
Hospital de Mataró, Consorci Sanitari del Maresme, Mataró, Barcelona, Spain
Synta Pharmaceuticals Investigational Site, Santander, Cantabria, Spain
Onkologikoa, San Sebastian, Guipuzcoa, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
H.U. Vall d'Hebrón, Barcelona, , Spain
Synta Pharmaceuticals Investigational Site, Barcelona, , Spain
H.U. Reina Sofía, Córdoba, , Spain
Synta Pharmaceuticals Investigational Site, Girona, , Spain
Synta Pharmaceuticals Investigational Site, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Synta Pharmaceuticals Investigational Site, Madrid, , Spain
F. Jiménez Diaz, Madrid, , Spain
Synta Pharmaceuticals Investigational Site, Madrid, , Spain
Hospital Madrid Norte Sanchinarro, Madrid, , Spain
Synta Pharmaceuticals Investigational Site, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Synta Pharmaceuticals Investigational Site, Cherkasy, , Ukraine
Synta Pharmaceuticals Investigational Site, Chernivtsi, , Ukraine
Synta Pharmaceuticals Investigational Site, Dnepropetrovsk, , Ukraine
Synta Pharmaceuticals Investigational Site, Donetsk, , Ukraine
Synta Pharmaceuticals Investigational Site, Donetsk, , Ukraine
Synta Pharmaceuticals Investigational Site, Ivano-Frankivsk, , Ukraine
Synta Pharmaceuticals Investigative Site, Kharkiv, , Ukraine
Synta Pharmaceuticals Investigational Site, Khmelnytskyi, , Ukraine
Synta Pharmaceuticals Investigational Site, Kirovohrad, , Ukraine
Synta Pharmaceuticals Investigational Site, Kryvyi Rih, , Ukraine
Synta Pharmaceuticals Investigational Site, Kyiv, , Ukraine
Synta Pharmaceuticals Investigational Site, Makiivka, , Ukraine
Synta Pharmaceuticals Investigational Site, Poltava, , Ukraine
Synta Pharmaceuticals Investigational Site, Simferopol, , Ukraine
Synta Pharmaceuticals Investigational Site, Sumy, , Ukraine
Synta Pharmaceuticals Investigational Site, Uzhhorod, , Ukraine
Synta Pharmaceuticals Investigational Site, Vinnytsia, , Ukraine
Synta Pharmaceuticals Investigational Site, Truro, Cornwall, United Kingdom
Synta Pharmaceuticals Investigational Site, Shrewsbury, Shropshire, United Kingdom
Synta Pharmaceuticals Investigational Site, Sutton, Surrey, United Kingdom
Synta Pharmaceuticals Investigational Site, Swindon, Wiltshire, United Kingdom
Synta Pharmaceuticals Investigational Site, Cardiff, , United Kingdom
Synta Pharmaceuticals Investigational Site, Edinburgh, , United Kingdom
Synta Pharmaceuticals Investigational Site, Leicester, , United Kingdom
Synta Pharmaceuticals Investigational Site, London, , United Kingdom
Synta Pharmaceuticals Investigational Site, London, , United Kingdom
Synta Pharmaceuticals Investigational Site, London, , United Kingdom
Synta Pharmaceuticals Investigational Site, Nottingham, , United Kingdom
Synta Pharmaceuticals Investigational Site, Southampton, , United Kingdom
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