AzTrials
AzTrials

Non-Small-Cell Lung AdenocarcinomaPhase 3Galaxy 2NCT01798485

A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

A Phase 3 study testing Docetaxel and Ganetespib in people with Non-Small-Cell Lung Adenocarcinoma and Non-small Cell Lung Cancer Stage IIIB, run by Synta Pharmaceuticals Corp. at 267 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel and Ganetespib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
267 sitesin 20 countries
Study dates
Apr 2013to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

267 sites in 20 countries.

267 sites in 20 countries

United States78 sites

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Pacific Cancer Medical Center, Inc

    Anaheim, California, 92801

  • AAMC Oncology and Hematology

    Annapolis, Maryland, 21401

  • Texas Oncology-Arlington North

    Arlington, Texas, 76012

  • Texas Oncology - Arlington South

    Arlington, Texas, 76014

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Comprehensive Blood & Cancer Center

    Bakersfield, California, 93309

  • Texas Oncology, P.A.

    Beaumont, Texas, 77702

  • The Center for Cancer and Blood Disorders (CCBD) - Bethesda

    Bethesda, Maryland, 20817

  • Lynn Cancer Institute Center for Hematology Oncology

    Boca Raton, Florida, 33486

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • St. Louis Cancer Care, LLP - North County

    Bridgeton, Missouri, 63044

  • University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Erlanger Institute for Clinical Research

    Chattanooga, Tennessee, 37403

  • Associates In Oncology and Hematology

    Chattanooga, Tennessee, 37421

  • University Of Chicago Medical Center

    Chicago, Illinois, 60637

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • Halifax Health - Medical Center

    Daytona Beach, Florida, 32114

  • Cancer Care Specialists of Central Illinois, S.C.

    Decatur, Illinois, 62526

  • University of Miami Health System Sylvester at Deerfield Beach

    Deerfield Beach, Florida, 33442-7753

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Breast Cancer Center

    Duarte, California, 91010

  • St. Luke's Hospital Duluth

    Duluth, Minnesota, 55805

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Arizona Oncology Associates PC- NAHOA

    Flagstaff, Arizona, 86001

  • Fort Wayne Medical Oncology and Hematology Inc

    Fort Wayne, Indiana, 46804

  • Green Bay Oncology, Ltd. - St. Mary's Site

    Green Bay, Wisconsin, 54303-3216

  • Green Bay Oncology

    Green Bay, Wisconsin, 54307

  • Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • The John R Marsh Cancer Center

    Hagerstown, Maryland, 21742

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Houston Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Millennium Oncology

    Houston, Texas, 77090

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • Loma Linda University Cancer Center

    Loma Linda, California, 92345

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Baptist Health Medical Group Oncology, LLC

    Miami, Florida, 33176

  • Mary Babb Cancer Center

    Morgantown, West Virginia, 26506

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Eastern Connecticut Hematology Associates

    Norwich, Connecticut, 06360

  • St. Joseph Hospital, Center for Cancer Prevention and Treatment

    Orange, California, 92868

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Arizona Oncology Associates, PC- NAHOA

    Prescott Valley, Arizona, 86314

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California, 90277

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • UC Davis Medical Center - UC Davis Comprehensive Cancer

    Sacramento, California, 95817

  • Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Cancer Care Centers Of South Texas

    San Antonio, Texas, 78212

  • Cancer Care Centers Of South Texas

    San Antonio, Texas, 78217

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78258

  • Santa Barbara Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105-4230

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania, 18840

  • Northern Arizona Hematology & Oncology Associates

    Sedona, Arizona, 86336

  • Texas Oncology - Sherman

    Sherman, Texas, 75090

  • City of Hope- South Pasadena

    South Pasadena, California, 91030

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • University of South Florida - H. Lee Moffitt

    Tampa, Florida, 33612

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85715

  • Tulsa Cancer Institute, PLLC

    Tulsa, Oklahoma, 74146

  • Prairie Lakes Healthcare System

    Watertown, South Dakota, 57201

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • New Hanover Regional Medical Center - Zimmer Cancer Center

    Wilmington, North Carolina, 28401

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia23 sites

  • Synta Pharmaceuticals Investigational Site

    Chelyabinsk, 454087

  • Synta Pharmaceuticals Investigational Site

    Ivanovo, 153040

  • Synta Pharmaceuticals Investigational Site

    Izhevsk, 426067

  • Synta Pharmaceuticals Investigational Site

    Kemerovo, 650036

  • Synta Pharmaceuticals Investigational Site

    Krasnoyarsk, 660133

  • Synta Pharmaceuticals Investigational Site

    Kursk, 305035

  • Synta Pharmaceuticals Investigational Site

    Lipetsk, 398005

  • Synta Pharmaceuticals Investigational Site

    Moscow, 115478

  • Synta Pharmaceuticals Investigational Site

    Nizhny Novgorod, 603081

  • Synta Pharmaceuticals Investigational Site

    Novosibirsk, 630047

  • Synta Pharmaceuticals Investigational Site

    Omsk, 644013

  • Synta Pharmaceuticals Investigational Site

    Oryol, 302020

  • Synta Pharmaceuticals Investigational Site

    Rostov-on-Don, 344037

  • Synta Pharmaceuticals Investigational Site

    Saint Petersburg, 194017

  • Synta Pharmaceuticals Investigational Site

    Saint Petersburg, 197758

  • Synta Pharmaceuticals Investigational Site

    Saint Petersburg, 198255

  • Synta Pharmaceuticals Investigational Site

    Samara, 443031

  • Synta Pharmaceuticals Investigational Site

    Saransk, 430032

  • Synta Pharmaceuticals Investigational Site

    Sochi, 354057

  • Synta Pharmaceuticals Investigational Site

    Stavropol, 355047

  • Synta Pharmaceuticals Investigational Site

    Ufa, 450000

  • Synta Pharmaceuticals Investigational Site

    Ufa, 450054

  • Synta Pharmaceuticals Investigational Site

    Yekaterinburg, 620036

Other trials in Russia

Germany22 sites

  • Gesundheitszentrum Wetterau

    Bad Nauheim, Hesse, 61231

  • MVZ Äerzteforum Seestraße

    Berlin, 13347

  • Ev. Krankenhaus Bielefeld

    Bielefeld, 33611

  • Kliniken der Stadt Köln gGmbH

    Cologne, North Rhine-Westphalia, 51109

  • Klinikum Frankfurt An Der Oder

    Frankfurt (Oder), 15236

  • Johann Wolfgang Goethe University Clinic Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Johann Wolfgang Goethe University Clinic Frankfurt

    Frankfurt am Main, Hesse, D-60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Asklepios Fachklinik München-Gauting

    Gauting, Bavaria, 82131

  • Pneumologisches Forschungsinstitut an der Lungenclinic Gross

    Großhansdorf, Schleswig-Holstein, 22927

  • Practice Laack

    Hamburg, 20251

  • Universitaetsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Klinikum Kassel

    Kassel, Hesse, 34125

  • Universitätsklinikum Leipzig [Pneumologie]

    Leipzig, Saxony, 04103

  • Unikl. Schleswig-Holstein - Lübeck

    Lübeck, 23538

  • J. Gutenberg Uni.Mainz

    Mainz, 55101

  • Medizinische Fakultät Mannheim Uni Heidelberg

    Mannheim, 68167

  • Klinikum Bogenhausen

    Munich, Bavaria, 81925

  • Gemeinschaftspraxis fuer Haematologie und Onkologie

    Münster, 48149

  • Klinikum Offenbach GmbH

    Offenbach, 63069

  • Universiaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, Baden-Wurttemberg, 78052

Other trials in Germany

Spain21 sites

  • Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera

    A Coruña, A Coruña, 15006

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • H.U. Vall d'Hebrón

    Barcelona, 08035

  • Synta Pharmaceuticals Investigational Site

    Barcelona, 08036

  • H.U. Reina Sofía

    Córdoba, 14004

  • Onkologikoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Synta Pharmaceuticals Investigational Site

    Girona, 17007

  • Synta Pharmaceuticals Investigational Site

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Synta Pharmaceuticals Investigational Site

    Madrid, 28034

  • F. Jiménez Diaz

    Madrid, 28040

  • Synta Pharmaceuticals Investigational Site

    Madrid, 28041

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

  • Synta Pharmaceuticals Investigational Site

    Madrid, 28223

  • Synta Pharmaceuticals Investigational Site

    Málaga, Andalusia, 29010

  • Hospital de Mataró, Consorci Sanitari del Maresme

    Mataró, Barcelona, 08304

  • Synta Pharmaceuticals Investigational Site

    Oviedo, Principality of Asturias, 33006

  • H. Son Llàtzer

    Palma de Mallorca, Balearic Islands, 07198

  • Synta Pharmaceuticals Investigational Site

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 460026

Other trials in Spain

Ukraine17 sites

  • Synta Pharmaceuticals Investigational Site

    Cherkasy, 18009

  • Synta Pharmaceuticals Investigational Site

    Chernivtsi, 58013

  • Synta Pharmaceuticals Investigational Site

    Dnipro, 49102

  • Synta Pharmaceuticals Investigational Site

    Donetsk, 83087

  • Synta Pharmaceuticals Investigational Site

    Donetsk, 83092

  • Synta Pharmaceuticals Investigational Site

    Ivano-Frankivsk, 76000

  • Synta Pharmaceuticals Investigative Site

    Kharkiv, 61070

  • Synta Pharmaceuticals Investigational Site

    Khmelnytskyi, 29009

  • Synta Pharmaceuticals Investigational Site

    Kirovohrad, 25011

  • Synta Pharmaceuticals Investigational Site

    Kryvyi Rih, 50048

  • Synta Pharmaceuticals Investigational Site

    Kyiv, 03115

  • Synta Pharmaceuticals Investigational Site

    Makiivka, 86120

  • Synta Pharmaceuticals Investigational Site

    Poltava, 36011

  • Synta Pharmaceuticals Investigational Site

    Simferopol, 95023

  • Synta Pharmaceuticals Investigational Site

    Sumy, 40022

  • Synta Pharmaceuticals Investigational Site

    Uzhhorod, 88014

  • Synta Pharmaceuticals Investigational Site

    Vinnytsia, 21021

Other trials in Ukraine

Italy13 sites

  • CRO, IRCCS, Istituto Nazionale Tumori

    Aviano, Pordenone, 33081

  • Policlinico S.Orsola Malpighi, AOU di Bologna

    Bologna, 40138

  • AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

    Genova, 16132

  • Irccs Irst

    Meldola, Forli, 47014

  • Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a

    Milan, 20141

  • Azienda Ospedaliera San Gerardo

    Monza, Lombardy, 20900

  • Iov-Irccs

    Padova, 35128

  • Ospedale S.Maria della Misericordia, AO di Perugia, Universi

    Perugia, 06156

  • Ospedale Guglielmo da Saliceto, AUSL Piacenza

    Piacenza, 29100

  • Istituti Fisioterapici Ospitalieri Regina Elena

    Roma, Roma, 00144

  • Azienda Policlinico Umberto I

    Rome, Roma, 00161

  • Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

    Verona, 37134

  • Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo

    Viterbo, Lazio, 01100

Other trials in Italy

Poland12 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-540

  • Szpital Wojewodzki Zespolony

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Medica Pro Familia Sp. z o.o. S.K.A.

    Krakow, Lesser Poland Voivodeship, 31-002

  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika

    Lodz, Łódź Voivodeship, 93-513

  • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

    Łomża, Podlaskie Voivodeship, 18-400

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, Masovian Voivodeship, 05-400

  • Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach

    Pilchowice, 44145

  • NZOZ Med Polonia

    Poznan, Greater Poland Voivodeship, 60-693

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii

    Poznan, Greater Poland Voivodeship, 60569

  • Szpital Specjalistyczny

    Prabuty, 82-550

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

United Kingdom12 sites

  • Synta Pharmaceuticals Investigational Site

    Cardiff, CF14 2TL

  • Synta Pharmaceuticals Investigational Site

    Edinburgh, EH4 2XU

  • Synta Pharmaceuticals Investigational Site

    Leicester, LEI 5WW

  • Synta Pharmaceuticals Investigational Site

    London, SE1 9RT

  • Synta Pharmaceuticals Investigational Site

    London, SW3 6JJ

  • Synta Pharmaceuticals Investigational Site

    London, W6 8RF

  • Synta Pharmaceuticals Investigational Site

    Nottingham, NG5 1PB

  • Synta Pharmaceuticals Investigational Site

    Shrewsbury, Shropshire, SY3 8XQ

  • Synta Pharmaceuticals Investigational Site

    Southampton, SO16 6YD

  • Synta Pharmaceuticals Investigational Site

    Sutton, Surrey, SM2 5PT

  • Synta Pharmaceuticals Investigational Site

    Swindon, Wiltshire, SN3 6BB

  • Synta Pharmaceuticals Investigational Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

France10 sites

  • Centre D'Oncologie Du Pays Basque

    Bayonne, Pyrénées-Atlantiques, 64100

  • Chi creteil

    Créteil, Val-de-Marne, 94010

  • CHI des Alpes du Sud

    Gap, Hautes-Alpes, 5000

  • Chu De Grenoble - Hopital Michallon

    Grenoble, 38700

  • Centre Léon Bérard

    Lyon, 69373

  • Groupe Hospitalier Cochin

    Paris, 75679

  • Centre Hospitalier Universitaire de Rennes - Hopital d

    Rennes, 35033

  • Hôpital Charles Nicolle

    Rouen, 76000

  • CHRU de Strasbourg

    Strasbourg, 67091

  • Centre Hosptalier De Villefranche-Sur-Saone

    Villefranche-sur-Saône, Rhône, 69655

Other trials in France

Austria8 sites

  • Landesklinikum Krems

    Krems, Lower Austria, 3500

  • Bezirkskrankenhaus Kufstein [Onkologie]

    Kufstein, Tyrol, A-6330

  • Krankenhaus Der Barmherzigen Schwestern

    Linz, Upper Austria, 4010

  • Allgemeines Krankenhaus Linz

    Linz, 4021

  • Elisabeth Linz Hospital

    Linz, 4021

  • Otto Wagner Spital

    Vienna, 1140

  • Sozialmedizinisches Zentrum Baumgartner Höhe

    Vienna, 1145

  • Klinikum Wels-Grieskirchen

    Wels, Upper Austria, A-4600

Other trials in Austria

Belgium8 sites

  • Cliniques Universitaire Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi, Hainaut, 6000

  • INDC Entité Jolimontoise - Polyclinique de Jolimont

    Haine-Saint-Paul, Hainaut, 1700

  • CHR de la Citadelle - Site Citadelle

    Liège, 4000

  • AZ Sint-Maarten - Campus Leopoldstraat

    Mechelen, Antwerpen, 2800

  • Clinique Saint-Pierre Ottignies

    Ottignies, Brabant Wallon, 1340

  • Algemeen Stedelijk Ziekenhuis - Campus Aalst

    Roeselaere, West-Vlaanderen, 8800

  • CHU Dinant Godinne UCL Namur

    Yvoir, Namur, 5533

Other trials in Belgium

Romania8 sites

  • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca

    Cluj-Napoca, 400015

  • Medisprof

    Cluj-Napoca, 400058

  • Centrul de Oncologie Sf. Nectarie

    Craiova, 200385

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Oncomed

    Timișoara, 300239

Other trials in Romania

Bosnia and Herzegovina7 sites

  • Clinical Centre Banja Luka

    Banja Luka, Republika Srpska, 78000

  • Clinical Hospital Mostar

    Mostar, 88108

  • Clinical Center University of Sarajevo, Clinic of Oncology

    Sarajevo, 71000

  • University Clinical Centre Sarajevo

    Sarajevo, 71000

  • University Clinical Center Tuzla

    Tuzla, Tuzlanski kanton, 75000

  • University Clinical Center Tuzla

    Tuzla, 75000

  • Kantonalna bolnica Zenica

    Zenica, 72000

Other trials in Bosnia and Herzegovina

Hungary7 sites

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, Pest County, 1145

  • Semmelweis Egyetem

    Budapest, 1125

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, 1529

  • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

    Deszk, Csongrád megye, 6772

  • Békés Megyei Pándy Kálmán Kórház

    Gyula, 5703

  • CRU Hungary Kft.

    Miskolc, 3529

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

Netherlands6 sites

  • Ziekenhuis Assen

    Assen, Drenthe, 9401 RK

  • Ziekenhuis St Jansdal

    Harderwijk, Gelderland, 3844 DG

  • academisch ziekenhuis Maastricht

    Maastricht, Limburg, 6229 HX

  • Sint Antoniusziekenhuis, location Utrecht

    Utrecht, 3543 AZ

  • Gelre Ziekenhuis Zutphen

    Zutphen, Gelderland, 7207 AE

  • Isala Klinieken Zwolle

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Serbia5 sites

  • Clinical Centre of Serbia

    Belgrade, Belgrade, 11000

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • Institute for pulmonary diseases of Vojvodine

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, Šumadijski okrug, 34 000

  • Clinical Centre Nis

    Niš, Nišavski okrug, 18000

Other trials in Serbia

Czechia4 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Canada2 sites

  • Mc Gill University-MUHC

    Montreal, Quebec, H2W 1S6

  • Princess Margaret Hospital

    Toronto, Ontario, MG5 2M9

Other trials in Canada

Croatia2 sites

  • Opca bolnica Pula

    Pula, Istria County, 52000

  • University Hospital Center Zagreb

    Zagreb, City of Zagreb, 10 000

Other trials in Croatia

Slovenia2 sites

  • Univerzitetna klinika za pljucne bolesti in alergijo Golnik

    Golnik, 4204

  • Onkoloski institut Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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

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.

Read the 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.

Being tested
Docetaxel, Ganetespib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere, Docecad

    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.

  • GanetespibDrug

    Also called STA-9090

    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.

Study groups in NCT01798485
Study groupRoleWhat they receive
Ganetespib and DocetaxelExperimentalGanetespib (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.
Receives: Drug: Docetaxel; Drug: Ganetespib
DocetaxelActive comparatorDocetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival as of 19 October 2015

    Overall survival (OS) was measured from the date of randomization to the date of death from any cause.

    Measured: up to 36 months

Secondary outcomes (13)

  1. Progression-free Survival (PFS) as of 19 October 2015

    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.

    Measured: up to 36 months

  2. Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015

    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.

    Measured: up to 36 months

  3. Objective Response Rate (ORR) as of 19 October 2015

    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.

    Measured: up to 36 months

  4. Disease Control Rate (DCR) as of 19 October 2015

    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.

    Measured: up to 36 months

  5. Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015

    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.

    Measured: up to 36 months

  6. Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015

    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.

    Measured: up to 36 months

  7. Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015

    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.

    Measured: up to 36 months

  8. Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015

    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.

    Measured: up to 36 months

  9. Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015

    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.

    Measured: up to 36 months

  10. Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015

    Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.

    Measured: up to 36 months

  11. Participants With Treatment-Emergent Adverse Events as of 23 December 2015

    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.

    Measured: up to 36 months

  12. Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey

    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.

    Measured: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial

  13. Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test

    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.

    Measured: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: The study was stopped after the first Interim Analysis due to futility.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01798485
Sponsor's protocol ID
9090-14
Other IDs
2012-004349-34
Acronym
Galaxy 2
Status last verified
May 2016
First submitted
4 Feb 2013
Last updated
1 Jul 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and Ganetespib in people with Non-Small-Cell Lung Adenocarcinoma and Non-small Cell Lung Cancer Stage IIIB, run by Synta Pharmaceuticals Corp. at 267 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 267 sites in United States, Russia, Germany, Spain, Ukraine and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival as of 19 October 2015 (time frame: up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01798485.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.

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