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

NCT01798485 | Terminated Phase 3 Results DMC

• 2 other identifiers: 9090-142012-004349-34
• Study Type: interventional
• Target: 696
• Locations: 20 countries
• Sites: 267

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.

Conditions

Non-Small-Cell Lung Adenocarcinoma; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (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.

  up to 36 months

Secondary Outcomes (13)

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

  up to 36 months

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

  up to 36 months

• Objective Response Rate (ORR) as of 19 October 2015

  up to 36 months

• Disease Control Rate (DCR) as of 19 October 2015

  up to 36 months

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

  up to 36 months

Other Outcomes (1)

• Exploratory Biomarker Analyses

  up to 36 months

Study Arms (2)

Ganetespib and Docetaxel

EXPERIMENTAL

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; Drug: Ganetespib

Docetaxel

ACTIVE COMPARATOR

Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.

Drug: Docetaxel

Interventions

Docetaxel DRUG

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.

Also known as: Taxotere, Docecad

Docetaxel; Ganetespib and Docetaxel

Ganetespib DRUG

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.

Also known as: STA-9090

Ganetespib and Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (267)

Arizona Oncology Associates PC- NAHOA

Flagstaff, Arizona, 86001, United States

Location

Arizona Oncology Associates, PC- NAHOA

Prescott Valley, Arizona, 86314, United States

Location

Northern Arizona Hematology & Oncology Associates

Sedona, Arizona, 86336, United States

Location

Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85715, United States

Location

Pacific Cancer Medical Center, Inc

Anaheim, California, 92801, United States

Location

Comprehensive Blood & Cancer Center

Bakersfield, California, 93309, United States

Location

City of Hope Comprehensive Breast Cancer Center

Duarte, California, 91010, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Loma Linda University Cancer Center

Loma Linda, California, 92345, United States

Location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

St. Joseph Hospital, Center for Cancer Prevention and Treatment

Orange, California, 92868, United States

Location

Cancer Care Associates Medical Group, Inc.

Redondo Beach, California, 90277, United States

Location

UC Davis Medical Center - UC Davis Comprehensive Cancer

Sacramento, California, 95817, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, 93105-4230, United States

Location

City of Hope- South Pasadena

South Pasadena, California, 91030, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Eastern Connecticut Hematology Associates

Norwich, Connecticut, 06360, United States

Location

Medical Oncology Hematology Consultants, PA

Newark, Delaware, 19713, United States

Location

Lynn Cancer Institute Center for Hematology Oncology

Boca Raton, Florida, 33486, United States

Location

Halifax Health - Medical Center

Daytona Beach, Florida, 32114, United States

Location

University of Miami Health System Sylvester at Deerfield Beach

Deerfield Beach, Florida, 33442-7753, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Baptist Health Medical Group Oncology, LLC

Miami, Florida, 33176, United States

Location

University of South Florida - H. Lee Moffitt

Tampa, Florida, 33612, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, 33401, United States

Location

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, 30060, United States

Location

University Of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Fort Wayne Medical Oncology and Hematology Inc

Fort Wayne, Indiana, 46804, United States

Location

AAMC Oncology and Hematology

Annapolis, Maryland, 21401, United States

Location

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

Bethesda, Maryland, 20817, United States

Location

The John R Marsh Cancer Center

Hagerstown, Maryland, 21742, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48909, United States

Location

St. Luke's Hospital Duluth

Duluth, Minnesota, 55805, United States

Location

Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

St. Louis Cancer Care, LLP - North County

Bridgeton, Missouri, 63044, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, 11733, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

New Hanover Regional Medical Center - Zimmer Cancer Center

Wilmington, North Carolina, 28401, United States

Location

Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Tulsa Cancer Institute, PLLC

Tulsa, Oklahoma, 74146, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Guthrie Medical Group, PC

Sayre, Pennsylvania, 18840, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Prairie Lakes Healthcare System

Watertown, South Dakota, 57201, United States

Location

Erlanger Institute for Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

Associates In Oncology and Hematology

Chattanooga, Tennessee, 37421, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Texas Oncology-Arlington North

Arlington, Texas, 76012, United States

Location

Texas Oncology - Arlington South

Arlington, Texas, 76014, United States

Location

Texas Oncology, P.A.

Beaumont, Texas, 77702, United States

Location

Texas Oncology, PA

Dallas, Texas, 75246, United States

Location

Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Millennium Oncology

Houston, Texas, 77090, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

Cancer Care Centers Of South Texas

San Antonio, Texas, 78212, United States

Location

Cancer Care Centers Of South Texas

San Antonio, Texas, 78217, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78258, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Cancer Care Northwest

Spokane Valley, Washington, 99216, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Mary Babb Cancer Center

Morgantown, West Virginia, 26506, United States

Location

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

Green Bay, Wisconsin, 54303-3216, United States

Location

Green Bay Oncology

Green Bay, Wisconsin, 54307, United States

Location

Landesklinikum Krems

Krems, Lower Austria, 3500, Austria

Location

Bezirkskrankenhaus Kufstein [Onkologie]

Kufstein, Tyrol, A-6330, Austria

Location

Krankenhaus Der Barmherzigen Schwestern

Linz, Upper Austria, 4010, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, A-4600, Austria

Location

Allgemeines Krankenhaus Linz

Linz, 4021, Austria

Location

Elisabeth Linz Hospital

Linz, 4021, Austria

Location

Otto Wagner Spital

Vienna, 1140, Austria

Location

Sozialmedizinisches Zentrum Baumgartner Höhe

Vienna, 1145, Austria

Location

AZ Sint-Maarten - Campus Leopoldstraat

Mechelen, Antwerpen, 2800, Belgium

Location

Clinique Saint-Pierre Ottignies

Ottignies, Brabant Wallon, 1340, Belgium

Location

Grand Hôpital de Charleroi - Site Notre-Dame

Charleroi, Hainaut, 6000, Belgium

Location

INDC Entité Jolimontoise - Polyclinique de Jolimont

Haine-Saint-Paul, Hainaut, 1700, Belgium

Location

CHU Dinant Godinne UCL Namur

Yvoir, Namur, 5533, Belgium

Location

Algemeen Stedelijk Ziekenhuis - Campus Aalst

Roeselaere, West-Vlaanderen, 8800, Belgium

Location

Cliniques Universitaire Saint-Luc

Brussels, 1200, Belgium

Location

CHR de la Citadelle - Site Citadelle

Liège, 4000, Belgium

Location

Clinical Centre Banja Luka

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla

Tuzla, Tuzlanski kanton, 75000, Bosnia and Herzegovina

Location

Clinical Hospital Mostar

Mostar, 88108, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo, Clinic of Oncology

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Centre Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla

Tuzla, 75000, Bosnia and Herzegovina

Location

Kantonalna bolnica Zenica

Zenica, 72000, Bosnia and Herzegovina

Location

Princess Margaret Hospital

Toronto, Ontario, MG5 2M9, Canada

Location

Mc Gill University-MUHC

Montreal, Quebec, H2W 1S6, Canada

Location

University Hospital Center Zagreb

Zagreb, City of Zagreb, 10 000, Croatia

Location

Opca bolnica Pula

Pula, Istria County, 52000, Croatia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

CHI des Alpes du Sud

Gap, Hautes-Alpes, 5000, France

Location

Centre D'Oncologie Du Pays Basque

Bayonne, Pyrénées-Atlantiques, 64100, France

Location

Centre Hosptalier De Villefranche-Sur-Saone

Villefranche-sur-Saône, Rhône, 69655, France

Location

Chi creteil

Créteil, Val-de-Marne, 94010, France

Location

Chu De Grenoble - Hopital Michallon

Grenoble, 38700, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Groupe Hospitalier Cochin

Paris, 75679, France

Location

Centre Hospitalier Universitaire de Rennes - Hopital d

Rennes, 35033, France

Location

Hôpital Charles Nicolle

Rouen, 76000, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universiaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

Location

Asklepios Fachklinik München-Gauting

Gauting, Bavaria, 82131, Germany

Location

Klinikum Bogenhausen

Munich, Bavaria, 81925, Germany

Location

Gesundheitszentrum Wetterau

Bad Nauheim, Hesse, 61231, Germany

Location

Johann Wolfgang Goethe University Clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Johann Wolfgang Goethe University Clinic Frankfurt

Frankfurt am Main, Hesse, D-60590, Germany

Location

Klinikum Kassel

Kassel, Hesse, 34125, Germany

Location

Kliniken der Stadt Köln gGmbH

Cologne, North Rhine-Westphalia, 51109, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Universitätsklinikum Leipzig [Pneumologie]

Leipzig, Saxony, 04103, Germany

Location

Pneumologisches Forschungsinstitut an der Lungenclinic Gross

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

MVZ Äerzteforum Seestraße

Berlin, 13347, Germany

Location

Ev. Krankenhaus Bielefeld

Bielefeld, 33611, Germany

Location

Klinikum Frankfurt An Der Oder

Frankfurt (Oder), 15236, Germany

Location

Practice Laack

Hamburg, 20251, Germany

Location

Unikl. Schleswig-Holstein - Lübeck

Lübeck, 23538, Germany

Location

J. Gutenberg Uni.Mainz

Mainz, 55101, Germany

Location

Medizinische Fakultät Mannheim Uni Heidelberg

Mannheim, 68167, Germany

Location

Gemeinschaftspraxis fuer Haematologie und Onkologie

Münster, 48149, Germany

Location

Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Location

Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

Deszk, Csongrád megye, 6772, Hungary

Location

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, Fejér, 8000, Hungary

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, Pest County, 1145, Hungary

Location

Semmelweis Egyetem

Budapest, 1125, Hungary

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, 1529, Hungary

Location

Békés Megyei Pándy Kálmán Kórház

Gyula, 5703, Hungary

Location

CRU Hungary Kft.

Miskolc, 3529, Hungary

Location

Irccs Irst

Meldola, Forli, 47014, Italy

Location

Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo

Viterbo, Lazio, 01100, Italy

Location

Azienda Ospedaliera San Gerardo

Monza, Lombardy, 20900, Italy

Location

CRO, IRCCS, Istituto Nazionale Tumori

Aviano, Pordenone, 33081, Italy

Location

Istituti Fisioterapici Ospitalieri Regina Elena

Roma, Roma, 00144, Italy

Location

Azienda Policlinico Umberto I

Rome, Roma, 00161, Italy

Location

Policlinico S.Orsola Malpighi, AOU di Bologna

Bologna, 40138, Italy

Location

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

Genova, 16132, Italy

Location

Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a

Milan, 20141, Italy

Location

Iov-Irccs

Padua, 35128, Italy

Location

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

Perugia, 06156, Italy

Location

Ospedale Guglielmo da Saliceto, AUSL Piacenza

Piacenza, 29100, Italy

Location

Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

Verona, 37134, Italy

Location

Ziekenhuis Assen

Assen, Drenthe, 9401 RK, Netherlands

Location

Ziekenhuis St Jansdal

Harderwijk, Gelderland, 3844 DG, Netherlands

Location

Gelre Ziekenhuis Zutphen

Zutphen, Gelderland, 7207 AE, Netherlands

Location

academisch ziekenhuis Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Location

Isala Klinieken Zwolle

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Sint Antoniusziekenhuis, location Utrecht

Utrecht, 3543 AZ, Netherlands

Location

NZOZ Med Polonia

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Poznan, Greater Poland Voivodeship, 60569, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-002, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, Masovian Voivodeship, 05-400, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-540, Poland

Location

Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

Łomża, Podlaskie Voivodeship, 18-400, Poland

Location

Szpital Wojewodzki Zespolony

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

Olsztyn, 10-357, Poland

Location

Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach

Pilchowice, 44145, Poland

Location

Szpital Specjalistyczny

Prabuty, 82-550, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M.Kopernika

Lodz, Łódź Voivodeship, 93-513, Poland

Location

Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

Bucharest, 022328, Romania

Location

Spitalul Clinic Coltea

Bucharest, 030171, Romania

Location

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

Location

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

Cluj-Napoca, 400015, Romania

Location

Medisprof

Cluj-Napoca, 400058, Romania

Location

Centrul de Oncologie Sf. Nectarie

Craiova, 200385, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Oncomed

Timișoara, 300239, Romania

Location

Synta Pharmaceuticals Investigational Site

Chelyabinsk, 454087, Russia

Location

Synta Pharmaceuticals Investigational Site

Ivanovo, 153040, Russia

Location

Synta Pharmaceuticals Investigational Site

Izhevsk, 426067, Russia

Location

Synta Pharmaceuticals Investigational Site

Kemerovo, 650036, Russia

Location

Synta Pharmaceuticals Investigational Site

Krasnoyarsk, 660133, Russia

Location

Synta Pharmaceuticals Investigational Site

Kursk, 305035, Russia

Location

Synta Pharmaceuticals Investigational Site

Lipetsk, 398005, Russia

Location

Synta Pharmaceuticals Investigational Site

Moscow, 115478, Russia

Location

Synta Pharmaceuticals Investigational Site

Nizhny Novgorod, 603081, Russia

Location

Synta Pharmaceuticals Investigational Site

Novosibirsk, 630047, Russia

Location

Synta Pharmaceuticals Investigational Site

Omsk, 644013, Russia

Location

Synta Pharmaceuticals Investigational Site

Oryol, 302020, Russia

Location

Synta Pharmaceuticals Investigational Site

Rostov-on-Don, 344037, Russia

Location

Synta Pharmaceuticals Investigational Site

Saint Petersburg, 194017, Russia

Location

Synta Pharmaceuticals Investigational Site

Saint Petersburg, 197758, Russia

Location

Synta Pharmaceuticals Investigational Site

Saint Petersburg, 198255, Russia

Location

Synta Pharmaceuticals Investigational Site

Samara, 443031, Russia

Location

Synta Pharmaceuticals Investigational Site

Saransk, 430032, Russia

Location

Synta Pharmaceuticals Investigational Site

Sochi, 354057, Russia

Location

Synta Pharmaceuticals Investigational Site

Stavropol, 355047, Russia

Location

Synta Pharmaceuticals Investigational Site

Ufa, 450000, Russia

Location

Synta Pharmaceuticals Investigational Site

Ufa, 450054, Russia

Location

Synta Pharmaceuticals Investigational Site

Yekaterinburg, 620036, Russia

Location

Clinical Centre of Serbia

Belgrade, Belgrade, 11000, Serbia

Location

Clinical Centre Nis

Niš, Nišavski okrug, 18000, Serbia

Location

Institute for Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Institute for pulmonary diseases of Vojvodine

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, Šumadijski okrug, 34 000, Serbia

Location

Univerzitetna klinika za pljucne bolesti in alergijo Golnik

Golnik, 4204, Slovenia

Location

Onkoloski institut Ljubljana

Ljubljana, 1000, Slovenia

Location

Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera

A Coruña, A Coruña, 15006, Spain

Location

Synta Pharmaceuticals Investigational Site

Málaga, Andalusia, 29010, Spain

Location

H. Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital de Mataró, Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Location

Synta Pharmaceuticals Investigational Site

Santander, Cantabria, 39008, Spain

Location

Onkologikoa

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Synta Pharmaceuticals Investigational Site

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

H.U. Vall d'Hebrón

Barcelona, 08035, Spain

Location

Synta Pharmaceuticals Investigational Site

Barcelona, 08036, Spain

Location

H.U. Reina Sofía

Córdoba, 14004, Spain

Location

Synta Pharmaceuticals Investigational Site

Girona, 17007, Spain

Location

Synta Pharmaceuticals Investigational Site

Madrid, 28033, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Synta Pharmaceuticals Investigational Site

Madrid, 28034, Spain

Location

F. Jiménez Diaz

Madrid, 28040, Spain

Location

Synta Pharmaceuticals Investigational Site

Madrid, 28041, Spain

Location

Hospital Madrid Norte Sanchinarro

Madrid, 28050, Spain

Location

Synta Pharmaceuticals Investigational Site

Madrid, 28223, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 460026, Spain

Location

Synta Pharmaceuticals Investigational Site

Cherkasy, 18009, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Chernivtsi, 58013, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Dnipro, 49102, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Donetsk, 83087, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Donetsk, 83092, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Ivano-Frankivsk, 76000, Ukraine

Location

Synta Pharmaceuticals Investigative Site

Kharkiv, 61070, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Khmelnytskyi, 29009, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Kirovohrad, 25011, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Kryvyi Rih, 50048, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Kyiv, 03115, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Makiivka, 86120, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Poltava, 36011, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Simferopol, 95023, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Sumy, 40022, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Uzhhorod, 88014, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Vinnytsia, 21021, Ukraine

Location

Synta Pharmaceuticals Investigational Site

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Shrewsbury, Shropshire, SY3 8XQ, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Swindon, Wiltshire, SN3 6BB, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Cardiff, CF14 2TL, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Leicester, LEI 5WW, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

London, SE1 9RT, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

London, SW3 6JJ, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

London, W6 8RF, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Nottingham, NG5 1PB, United Kingdom

Location

Synta Pharmaceuticals Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; STA 9090

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: President, Chief Executive Officer
• Organization: Synta Pharmaceuticals

781-541-7261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 25, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 1, 2016
• Results First Posted: July 1, 2016

Record last verified: 2016-05

Locations

CR (2); CZ (4); US (78); CA (2); DE (22); SE (5); IT (13); BE (8); SL (2); FR (10); PL (12); NL (6); HU (7); AU (8); BO (7); GB (12); RO (8); RU (23); ES (21); UA (17)