A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)

May 26, 2016 updated by: Synta Pharmaceuticals Corp.

A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

696

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Allgemeines Krankenhaus Linz
      • Linz, Austria, 4021
        • Elisabeth Linz Hospital
      • Wien, Austria, 1140
        • Otto Wagner Spital
      • Wien, Austria, 1145
        • Sozialmedizinisches Zentrum Baumgartner Höhe
    • Niederösterreich
      • Krems, Niederösterreich, Austria, 3500
        • Landesklinikum Krems
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4010
        • Krankenhaus der barmherzigen Schwestern
      • Wels, Oberösterreich, Austria, A-4600
        • Klinikum Wels-Grieskirchen
    • Tirol
      • Kufstein, Tirol, Austria, A-6330
        • Bezirkskrankenhaus Kufstein [Onkologie]
  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaire Saint-Luc
      • Liège, Belgium, 4000
        • CHR de la Citadelle - Site Citadelle
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • AZ Sint-Maarten - Campus Leopoldstraat
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340
        • Clinique Saint-Pierre Ottignies
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hôpital de Charleroi - Site Notre-Dame
      • Haine St. Paul, Hainaut, Belgium, 1700
        • INDC Entité Jolimontoise - Polyclinique de Jolimont
    • Namur
      • Yvoir, Namur, Belgium, 5533
        • CHU Dinant Godinne UCL Namur
    • West-Vlaanderen
      • Roeselaere, West-Vlaanderen, Belgium, 8800
        • Algemeen Stedelijk Ziekenhuis - campus Aalst
  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina, 88108
        • Clinical hospital Mostar
      • Sarajevo, Bosnia and Herzegovina, 71000
        • University Clinical Centre Sarajevo
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo, Clinic of Oncology
      • Tuzla, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla
      • Zenica, Bosnia and Herzegovina, 72000
        • Kantonalna bolnica Zenica
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • Clinical Centre Banja Luka
    • Tuzlanski kanton
      • Tuzla, Tuzlanski kanton, Bosnia and Herzegovina, 75000
        • University Clinical Center Tuzla
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, MG5 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • Mc Gill University-MUHC
  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10 000
        • University Hospital Center Zagreb
    • Istarska županija
      • Pula, Istarska županija, Croatia, 52000
        • Opca bolnica Pula
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Fakultni Nemocnice Olomouc
      • Ostrava - Poruba, Czech Republic, 708 52
        • Fakultni Nemocnice Ostrava
      • Prague, Czech Republic, 128 08
        • Vseobecna Fakultni Nemocnice V Praze
      • Prague, Czech Republic, 180 81
        • Nemocnice Na Bulovce
  • France
      • Grenoble, France, 38700
        • CHU de Grenoble - Hopital Michallon
      • Lyon, France, 69373
        • Centre LEON BERARD
      • Paris, France, 75679
        • Groupe Hospitalier Cochin
      • Rennes, France, 35033
        • Centre Hospitalier Universitaire de Rennes - Hopital d
      • Rouen, France, 76000
        • Hopital Charles Nicolle
      • Strasbourg, France, 67091
        • CHRU de Strasbourg
    • Hautes-Alpes
      • Gap, Hautes-Alpes, France, 5000
        • Chi Des Alpes Du Sud
    • Pyrénées-Atlantiques
      • Bayonne, Pyrénées-Atlantiques, France, 64100
        • Centre d'oncologie du Pays Basque
    • Rhône
      • Villefranche Sur Saone, Rhône, France, 69655
        • Centre Hosptalier De Villefranche-Sur-Saone
    • Val-de-Marne
      • Creteil, Val-de-Marne, France, 94010
        • CHI Créteil
  • Germany
      • Berlin, Germany, 13347
        • MVZ Äerzteforum Seestraße
      • Bielefeld, Germany, 33611
        • Ev. Krankenhaus Bielefeld
      • Frankfurt/Oder, Germany, 15236
        • Klinikum Frankfurt An Der Oder
      • Hamburg, Germany, 20251
        • Practice Laack
      • Lübeck, Germany, 23538
        • Unikl. Schleswig-Holstein - Lübeck
      • Mainz, Germany, 55101
        • J. Gutenberg Uni.Mainz
      • Mannheim, Germany, 68167
        • Medizinische Fakultät Mannheim Uni Heidelberg
      • Muenster, Germany, 48149
        • Gemeinschaftspraxis fuer Haematologie und Onkologie
      • Offenbach, Germany, 63069
        • Klinikum Offenbach GmbH
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Universitatsklinikum Freiburg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Universiaetsklinikum Ulm
      • Villingen-Schwenningen, Baden-Württemberg, Germany, 78052
        • Schwarzwald-Baar-Klinikum
    • Bayern
      • Gauting, Bayern, Germany, 82131
        • Asklepios Fachklinik München-Gauting
      • Muenchen, Bayern, Germany, 81925
        • Klinikum Bogenhausen
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Gesundheitszentrum Wetterau
      • Frankfurt, Hessen, Germany, 60590
        • Johann Wolfgang Goethe University Clinic Frankfurt
      • Frankfurt, Hessen, Germany, D-60590
        • Johann Wolfgang Goethe University Clinic Frankfurt
      • Kassel, Hessen, Germany, 34125
        • Klinikum Kassel
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51109
        • Kliniken der Stadt Koln gGmbH
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Universitaetsklinikum des Saarlandes
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig [Pneumologie]
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927
        • Pneumologisches Forschungsinstitut an der Lungenclinic Gross
  • Hungary
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem
      • Budapest, Hungary, 1529
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Gyula, Hungary, 5703
        • Bekes Megyei Pandy Kalman Korhaz
      • Miskolc, Hungary, 3529
        • CRU Hungary Kft.
    • Csongrád
      • Deszk, Csongrád, Hungary, 6772
        • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Fejér Megyei Szent György Egyetemi Oktató Kórház
    • Pest
      • Budapest, Pest, Hungary, 1145
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S.Orsola Malpighi, AOU di Bologna
      • Genova, Italy, 16132
        • AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a
      • Padova, Italy, 35128
        • Iov-Irccs
      • Perugia, Italy, 06156
        • Ospedale S.Maria della Misericordia, AO di Perugia, Universi
      • Piacenza, Italy, 29100
        • Ospedale Guglielmo da Saliceto, AUSL Piacenza
      • Roma, Italy, 00144
        • Istituti Fisioterapici Ospitalieri Regina Elena
      • Verona, Italy, 37134
        • Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
    • Forli
      • Meldola, Forli, Italy, 47014
        • Irccs Irst
    • Lazio
      • Viterbo, Lazio, Italy, 01100
        • Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • Azienda Ospedaliera San Gerardo
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • CRO, IRCCS, Istituto Nazionale Tumori
    • Roma
      • Rome, Roma, Italy, 00161
        • Azienda Policlinico Umberto I
  • Netherlands
      • Utrecht, Netherlands, 3543 AZ
        • Sint Antoniusziekenhuis, location Utrecht
    • Drenthe
      • Assen, Drenthe, Netherlands, 9401 RK
        • Ziekenhuis Assen
    • Gelderland
      • Harderwijk, Gelderland, Netherlands, 3844 DG
        • Ziekenhuis St Jansdal
      • Zutphen, Gelderland, Netherlands, 7207 AE
        • Gelre Ziekenhuis Zutphen
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Isala Klinieken Zwolle
  • Poland
      • Olsztyn, Poland, 10-357
        • Samodzielny Publiczny Zespol Gruzlicy I Chorob Pluc
      • Pilchowice, Poland, 44145
        • Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach
      • Prabuty, Poland, 82-550
        • Szpital Specjalistyczny
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-513
        • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-002
        • Medica Pro Familia sp. z o.o. S.K.A.
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Warszawa, Mazowieckie, Poland, 02-781
        • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-540
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Lomza, Podlaskie, Poland, 18-400
        • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
    • Warminsko-mazurskie
      • Elblag, Warminsko-mazurskie, Poland, 82-300
        • Szpital Wojewodzki Zespolony
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-693
        • NZOZ Med Polonia
      • Poznan, Wielkopolskie, Poland, 60569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii
  • Romania
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucharest, Romania, 022328
        • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
      • Bucuresti, Romania, 030171
        • Spitalul Clinic Coltea
      • Cluj Napoca, Romania, 400058
        • Medisprof
      • Cluj Napoca, Romania, 400015
        • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
      • Craiova, Romania, 200385
        • Centrul de Oncologie Sf. Nectarie
      • Iasi, Romania, 700483
        • Institutul Regional de Oncologie Iasi
      • Timisoara, Romania, 300239
        • Oncomed
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Synta Pharmaceuticals Investigational Site
      • Ekaterinburg, Russian Federation, 620036
        • Synta Pharmaceuticals Investigational Site
      • Ivanovo, Russian Federation, 153040
        • Synta Pharmaceuticals Investigational Site
      • Izhevsk, Russian Federation, 426067
        • Synta Pharmaceuticals Investigational Site
      • Kemerovo, Russian Federation, 650036
        • Synta Pharmaceuticals Investigational Site
      • Krasnoyarsk, Russian Federation, 660133
        • Synta Pharmaceuticals Investigational Site
      • Kursk, Russian Federation, 305035
        • Synta Pharmaceuticals Investigational Site
      • Lipetsk, Russian Federation, 398005
        • Synta Pharmaceuticals Investigational Site
      • Moscow, Russian Federation, 115478
        • Synta Pharmaceuticals Investigational Site
      • Nizhny Novgorod, Russian Federation, 603081
        • Synta Pharmaceuticals Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Synta Pharmaceuticals Investigational Site
      • Omsk, Russian Federation, 644013
        • Synta Pharmaceuticals Investigational Site
      • Orel, Russian Federation, 302020
        • Synta Pharmaceuticals Investigational Site
      • Rostov-on-Don, Russian Federation, 344037
        • Synta Pharmaceuticals Investigational Site
      • Samara, Russian Federation, 443031
        • Synta Pharmaceuticals Investigational Site
      • Saransk, Russian Federation, 430032
        • Synta Pharmaceuticals Investigational Site
      • Sochi, Russian Federation, 354057
        • Synta Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 194017
        • Synta Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • Synta Pharmaceuticals Investigational Site
      • St. Petersburg, Russian Federation, 198255
        • Synta Pharmaceuticals Investigational Site
      • Stavropol, Russian Federation, 355047
        • Synta Pharmaceuticals Investigational Site
      • Ufa, Russian Federation, 450000
        • Synta Pharmaceuticals Investigational Site
      • Ufa, Russian Federation, 450054
        • Synta Pharmaceuticals Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
      • Sremska Kamenica, Serbia, 21204
        • Institute for pulmonary diseases of Vojvodine
    • Belgrade
      • Beograd, Belgrade, Serbia, 11000
        • Clinical Centre of Serbia
    • Nišavski okrug
      • Nis, Nišavski okrug, Serbia, 18000
        • Clinical Centre Nis
    • Šumadijski okrug
      • Kragujevac, Šumadijski okrug, Serbia, 34 000
        • Clinical Center Kragujevac
  • Slovenia
      • Golnik, Slovenia, 4204
        • Univerzitetna klinika za pljucne bolesti in alergijo Golnik
      • Ljubljana, Slovenia, 1000
        • Onkološki Inštitut Ljubljana
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • H.U. Vall d'Hebron
      • Barcelona, Spain, 08036
        • Synta Pharmaceuticals Investigational Site
      • Córdoba, Spain, 14004
        • H.U. Reina Sofía
      • Girona, Spain, 17007
        • Synta Pharmaceuticals Investigational Site
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Madrid, Spain, 28033
        • Synta Pharmaceuticals Investigational Site
      • Madrid, Spain, 28034
        • Synta Pharmaceuticals Investigational Site
      • Madrid, Spain, 28040
        • F. Jiménez Diaz
      • Madrid, Spain, 28041
        • Synta Pharmaceuticals Investigational Site
      • Madrid, Spain, 28223
        • Synta Pharmaceuticals Investigational Site
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 460026
        • Hospital Universitari I Politecnic La Fe
    • A Coruña
      • La Coruña, A Coruña, Spain, 15006
        • Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera
    • Andalucía
      • Málaga, Andalucía, Spain, 29010
        • Synta Pharmaceuticals Investigational Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Synta Pharmaceuticals Investigational Site
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07198
        • H. Son Llàtzer
    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataró, Consorci Sanitari del Maresme
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Synta Pharmaceuticals Investigational Site
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Onkologikoa
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Synta Pharmaceuticals Investigational Site
      • Chernivtsi, Ukraine, 58013
        • Synta Pharmaceuticals Investigational Site
      • Dnepropetrovsk, Ukraine, 49102
        • Synta Pharmaceuticals Investigational Site
      • Donetsk, Ukraine, 83087
        • Synta Pharmaceuticals Investigational Site
      • Donetsk, Ukraine, 83092
        • Synta Pharmaceuticals Investigational Site
      • Ivano-Frankivsk, Ukraine, 76000
        • Synta Pharmaceuticals Investigational Site
      • Kharkiv, Ukraine, 61070
        • Synta Pharmaceuticals Investigative Site
      • Khmelnytskyi, Ukraine, 29009
        • Synta Pharmaceuticals Investigational Site
      • Kirovohrad, Ukraine, 25011
        • Synta Pharmaceuticals Investigational Site
      • Kryvyi Rih, Ukraine, 50048
        • Synta Pharmaceuticals Investigational Site
      • Kyiv, Ukraine, 03115
        • Synta Pharmaceuticals Investigational Site
      • Makiivka, Ukraine, 86120
        • Synta Pharmaceuticals Investigational Site
      • Poltava, Ukraine, 36011
        • Synta Pharmaceuticals Investigational Site
      • Simferopol, Ukraine, 95023
        • Synta Pharmaceuticals Investigational Site
      • Sumy, Ukraine, 40022
        • Synta Pharmaceuticals Investigational Site
      • Uzhhorod, Ukraine, 88014
        • Synta Pharmaceuticals Investigational Site
      • Vinnytsia, Ukraine, 21021
        • Synta Pharmaceuticals Investigational Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Synta Pharmaceuticals Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Synta Pharmaceuticals Investigational Site
      • Leicester, United Kingdom, LEI 5WW
        • Synta Pharmaceuticals Investigational Site
      • London, United Kingdom, SW3 6JJ
        • Synta Pharmaceuticals Investigational Site
      • London, United Kingdom, SE1 9RT
        • Synta Pharmaceuticals Investigational Site
      • London, United Kingdom, W6 8RF
        • Synta Pharmaceuticals Investigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • Synta Pharmaceuticals Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Synta Pharmaceuticals Investigational Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Synta Pharmaceuticals Investigational Site
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
        • Synta Pharmaceuticals Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Synta Pharmaceuticals Investigational Site
    • Wiltshire
      • Swindon, Wiltshire, United Kingdom, SN3 6BB
        • Synta Pharmaceuticals Investigational Site
  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Arizona Oncology Associates PC- NAHOA
      • Prescott Valley, Arizona, United States, 86314
        • Arizona Oncology Associates, PC- NAHOA
      • Sedona, Arizona, United States, 86336
        • Northern Arizona Hematology & Oncology Associates
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center, Inc.
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood & Cancer Center
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Breast Cancer Center
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Loma Linda, California, United States, 92345
        • Loma Linda University Cancer Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Orange, California, United States, 92868
        • St. Joseph Hospital, Center for Cancer Prevention and Treatment
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group, Inc.
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center - UC Davis Comprehensive Cancer
      • Santa Barbara, California, United States, 93105-4230
        • Santa Barbara Hematology Oncology Medical Group, Inc.
      • South Pasadena, California, United States, 91030
        • City of Hope- South Pasadena
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology Associates
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants, PA
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute Center for Hematology Oncology
      • Daytona Beach, Florida, United States, 32114
        • Halifax Health - Medical Center
      • Deerfield Beach, Florida, United States, 33442-7753
        • University of Miami Health System Sylvester at Deerfield Beach
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Miami, Florida, United States, 33176
        • Baptist Health Medical Group Oncology, LLC
      • Tampa, Florida, United States, 33612
        • University of South Florida - H. Lee Moffitt
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University - Winship Cancer Institute
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois, S.C.
      • Rockford, Illinois, United States, 61108
        • Saint Anthony Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology And Hematology Inc
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Aamc Oncology and Hematology
      • Bethesda, Maryland, United States, 20817
        • The Center for Cancer and Blood Disorders (CCBD) - Bethesda
      • Hagerstown, Maryland, United States, 21742
        • The John R Marsh Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Lansing, Michigan, United States, 48909
        • Sparrow Regional Cancer Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital Duluth
      • Saint Louis Park, Minnesota, United States, 55426
        • Frauenshuh Cancer Center
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • St. Louis Cancer Care, LLP - North County
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center - John Theurer Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Cancer Center
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Regional Medical Center - Zimmer Cancer Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Tulsa Cancer Institute, PLLC
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group, PC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Watertown, South Dakota, United States, 57201
        • Prairie Lakes Healthcare System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Associates in Oncology and Hematology
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Institute for Clinical Research
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Oncology-Arlington North
      • Arlington, Texas, United States, 76014
        • Texas Oncology - Arlington South
      • Beaumont, Texas, United States, 77702
        • Texas Oncology, P.A.
      • Dallas, Texas, United States, 75246
        • Texas Oncology, PA
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center
      • Houston, Texas, United States, 77090
        • Millennium Oncology
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital Research Institute
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78212
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78258
        • Cancer Care Centers of South Texas
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett
      • Spokane Valley, Washington, United States, 99216
        • Cancer Care Northwest
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Mary Babb Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303-3216
        • Green Bay Oncology, Ltd. - St. Mary's Site
      • Green Bay, Wisconsin, United States, 54307
        • Green Bay Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
  • Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
  • Prior therapy defined as 1 prior systemic therapy for advanced disease
  • Documented disease progression during or following most first line therapy for advanced disease
  • Adequate hematologic, hepatic, renal function

Exclusion Criteria:

  • Epidermal growth factor receptor (EGFR) mutations
  • Anaplastic lymphoma kinase (ALK) translocations
  • Predominantly squamous, adenosquamous or unclear histologic type
  • Active or untreated central nervous system (CNS) metastases
  • Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  • Serious cardiac illness or medical conditions
  • Pregnant or lactating women
  • Uncontrolled intercurrent illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ganetespib and Docetaxel
Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
Drug: Docetaxel
Docetaxel, 75 mg/m^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent.
Other Names:
  • Taxotere
  • Docecad
Drug: Ganetespib
Ganetespib, 150 mg/m^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent.
Other Names:
  • STA-9090
Active Comparator: Docetaxel
Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Drug: Docetaxel
Docetaxel, 75 mg/m^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent.
Other Names:
  • Taxotere
  • Docecad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival as of 19 October 2015
Time Frame: up to 36 months
Overall survival (OS) was measured from the date of randomization to the date of death from any cause.
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) as of 19 October 2015
Time Frame: up to 36 months

The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.

Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
up to 36 months
Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Time Frame: up to 36 months
OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal.
up to 36 months
Objective Response Rate (ORR) as of 19 October 2015
Time Frame: up to 36 months

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).

CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.
up to 36 months
Disease Control Rate (DCR) as of 19 October 2015
Time Frame: up to 36 months

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD).

CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks.
up to 36 months
Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015
Time Frame: up to 36 months

Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis.

CR was defined as the disappearance (or normalization) of all target lesions.

PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.
up to 36 months
Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Time Frame: up to 36 months

The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.

Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Elevated LDH includes values above the upper limit of normal.
up to 36 months
Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Time Frame: up to 36 months

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).

CR was defined as the disappearance (or normalization) of all target lesions.

PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

Elevated LDH includes values above the upper limit of normal.

This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
up to 36 months
Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Time Frame: up to 36 months

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD).

CR was defined as the disappearance (or normalization) of all target lesions.

PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks.

Elevated LDH includes values above the upper limit of normal.

This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
up to 36 months
Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015
Time Frame: up to 36 months
TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment.
up to 36 months
Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015
Time Frame: up to 36 months
Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.
up to 36 months
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
Time Frame: up to 36 months

Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.
up to 36 months
Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey
Time Frame: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial

The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and "0" represents dead, with some health states being worse than dead (<"0").

This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial
Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test
Time Frame: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial

The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.

Data were not summarized due to the early termination of the study due to futility.
Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Biomarker Analyses
Time Frame: up to 36 months
Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9090-14
  • 2012-004349-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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