A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
NCT ID: NCT01798485
Last Updated: 2016-07-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
696 participants
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Docetaxel
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Synta Pharmaceuticals Corp.
INDUSTRY
Responsible Party
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Locations
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Arizona Oncology Associates PC- NAHOA
Flagstaff, Arizona, United States
Arizona Oncology Associates, PC- NAHOA
Prescott Valley, Arizona, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Pacific Cancer Medical Center, Inc
Anaheim, California, United States
Comprehensive Blood & Cancer Center
Bakersfield, California, United States
City of Hope Comprehensive Breast Cancer Center
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
St. Joseph Hospital, Center for Cancer Prevention and Treatment
Orange, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
UC Davis Medical Center - UC Davis Comprehensive Cancer
Sacramento, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States
City of Hope- South Pasadena
South Pasadena, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Eastern Connecticut Hematology Associates
Norwich, Connecticut, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, United States
Halifax Health - Medical Center
Daytona Beach, Florida, United States
University of Miami Health System Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Baptist Health Medical Group Oncology, LLC
Miami, Florida, United States
University of South Florida - H. Lee Moffitt
Tampa, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc
Fort Wayne, Indiana, United States
AAMC Oncology and Hematology
Annapolis, Maryland, United States
The Center for Cancer and Blood Disorders (CCBD) - Bethesda
Bethesda, Maryland, United States
The John R Marsh Cancer Center
Hagerstown, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Luke's Hospital Duluth
Duluth, Minnesota, United States
Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
St. Louis Cancer Care, LLP - North County
Bridgeton, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Clinical Research Alliance
Lake Success, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
New Hanover Regional Medical Center - Zimmer Cancer Center
Wilmington, North Carolina, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Tulsa Cancer Institute, PLLC
Tulsa, Oklahoma, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
Erlanger Institute for Clinical Research
Chattanooga, Tennessee, United States
Associates In Oncology and Hematology
Chattanooga, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Texas Oncology-Arlington North
Arlington, Texas, United States
Texas Oncology - Arlington South
Arlington, Texas, United States
Texas Oncology, P.A.
Beaumont, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Houston Methodist Hospital Research Institute
Houston, Texas, United States
Millennium Oncology
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Texas Oncology - Sherman
Sherman, Texas, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Mary Babb Cancer Center
Morgantown, West Virginia, United States
Green Bay Oncology, Ltd. - St. Mary's Site
Green Bay, Wisconsin, United States
Green Bay Oncology
Green Bay, Wisconsin, United States
Landesklinikum Krems
Krems, Lower Austria, Austria
Bezirkskrankenhaus Kufstein [Onkologie]
Kufstein, Tyrol, Austria
Krankenhaus Der Barmherzigen Schwestern
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Allgemeines Krankenhaus Linz
Linz, , Austria
Elisabeth Linz Hospital
Linz, , Austria
Otto Wagner Spital
Vienna, , Austria
Sozialmedizinisches Zentrum Baumgartner Höhe
Vienna, , Austria
AZ Sint-Maarten - Campus Leopoldstraat
Mechelen, Antwerpen, Belgium
Clinique Saint-Pierre Ottignies
Ottignies, Brabant Wallon, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Hainaut, Belgium
INDC Entité Jolimontoise - Polyclinique de Jolimont
Haine-Saint-Paul, Hainaut, Belgium
CHU Dinant Godinne UCL Namur
Yvoir, Namur, Belgium
Algemeen Stedelijk Ziekenhuis - Campus Aalst
Roeselaere, West-Vlaanderen, Belgium
Cliniques Universitaire Saint-Luc
Brussels, , Belgium
CHR de la Citadelle - Site Citadelle
Liège, , Belgium
Clinical Centre Banja Luka
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Tuzlanski kanton, Bosnia and Herzegovina
Clinical Hospital Mostar
Mostar, , Bosnia and Herzegovina
Clinical Center University of Sarajevo, Clinic of Oncology
Sarajevo, , Bosnia and Herzegovina
University Clinical Centre Sarajevo
Sarajevo, , Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, , Bosnia and Herzegovina
Kantonalna bolnica Zenica
Zenica, , Bosnia and Herzegovina
Princess Margaret Hospital
Toronto, Ontario, Canada
Mc Gill University-MUHC
Montreal, Quebec, Canada
University Hospital Center Zagreb
Zagreb, City of Zagreb, Croatia
Opca bolnica Pula
Pula, Istria County, Croatia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
CHI des Alpes du Sud
Gap, Hautes-Alpes, France
Centre D'Oncologie Du Pays Basque
Bayonne, Pyrénées-Atlantiques, France
Centre Hosptalier De Villefranche-Sur-Saone
Villefranche-sur-Saône, Rhône, France
Chi creteil
Créteil, Val-de-Marne, France
Chu De Grenoble - Hopital Michallon
Grenoble, , France
Centre Léon Bérard
Lyon, , France
Groupe Hospitalier Cochin
Paris, , France
Centre Hospitalier Universitaire de Rennes - Hopital d
Rennes, , France
Hôpital Charles Nicolle
Rouen, , France
CHRU de Strasbourg
Strasbourg, , France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universiaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Asklepios Fachklinik München-Gauting
Gauting, Bavaria, Germany
Klinikum Bogenhausen
Munich, Bavaria, Germany
Gesundheitszentrum Wetterau
Bad Nauheim, Hesse, Germany
Johann Wolfgang Goethe University Clinic Frankfurt
Frankfurt am Main, Hesse, Germany
Johann Wolfgang Goethe University Clinic Frankfurt
Frankfurt am Main, Hesse, Germany
Klinikum Kassel
Kassel, Hesse, Germany
Kliniken der Stadt Köln gGmbH
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes
Homburg, Saarland, Germany
Universitätsklinikum Leipzig [Pneumologie]
Leipzig, Saxony, Germany
Pneumologisches Forschungsinstitut an der Lungenclinic Gross
Großhansdorf, Schleswig-Holstein, Germany
MVZ Äerzteforum Seestraße
Berlin, , Germany
Ev. Krankenhaus Bielefeld
Bielefeld, , Germany
Klinikum Frankfurt An Der Oder
Frankfurt (Oder), , Germany
Practice Laack
Hamburg, , Germany
Unikl. Schleswig-Holstein - Lübeck
Lübeck, , Germany
J. Gutenberg Uni.Mainz
Mainz, , Germany
Medizinische Fakultät Mannheim Uni Heidelberg
Mannheim, , Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie
Münster, , Germany
Klinikum Offenbach GmbH
Offenbach, , Germany
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó
Deszk, Csongrád megye, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, Fejér, Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Pest County, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, , Hungary
Békés Megyei Pándy Kálmán Kórház
Gyula, , Hungary
CRU Hungary Kft.
Miskolc, , Hungary
Irccs Irst
Meldola, Forli, Italy
Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo
Viterbo, Lazio, Italy
Azienda Ospedaliera San Gerardo
Monza, Lombardy, Italy
CRO, IRCCS, Istituto Nazionale Tumori
Aviano, Pordenone, Italy
Istituti Fisioterapici Ospitalieri Regina Elena
Roma, Roma, Italy
Azienda Policlinico Umberto I
Rome, Roma, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna, , Italy
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
Genova, , Italy
Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a
Milan, , Italy
Iov-Irccs
Padua, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia, Universi
Perugia, , Italy
Ospedale Guglielmo da Saliceto, AUSL Piacenza
Piacenza, , Italy
Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
Verona, , Italy
Ziekenhuis Assen
Assen, Drenthe, Netherlands
Ziekenhuis St Jansdal
Harderwijk, Gelderland, Netherlands
Gelre Ziekenhuis Zutphen
Zutphen, Gelderland, Netherlands
academisch ziekenhuis Maastricht
Maastricht, Limburg, Netherlands
Isala Klinieken Zwolle
Zwolle, Overijssel, Netherlands
Sint Antoniusziekenhuis, location Utrecht
Utrecht, , Netherlands
NZOZ Med Polonia
Poznan, Greater Poland Voivodeship, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznan, Greater Poland Voivodeship, Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Krakow, Lesser Poland Voivodeship, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Masovian Voivodeship, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
Łomża, Podlaskie Voivodeship, Poland
Szpital Wojewodzki Zespolony
Elblag, Warmian-Masurian Voivodeship, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, , Poland
Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach
Pilchowice, , Poland
Szpital Specjalistyczny
Prabuty, , Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
Lodz, Łódź Voivodeship, Poland
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
Bucharest, , Romania
Spitalul Clinic Coltea
Bucharest, , Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, , Romania
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
Cluj-Napoca, , Romania
Medisprof
Cluj-Napoca, , Romania
Centrul de Oncologie Sf. Nectarie
Craiova, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Oncomed
Timișoara, , Romania
Synta Pharmaceuticals Investigational Site
Chelyabinsk, , Russia
Synta Pharmaceuticals Investigational Site
Ivanovo, , Russia
Synta Pharmaceuticals Investigational Site
Izhevsk, , Russia
Synta Pharmaceuticals Investigational Site
Kemerovo, , Russia
Synta Pharmaceuticals Investigational Site
Krasnoyarsk, , Russia
Synta Pharmaceuticals Investigational Site
Kursk, , Russia
Synta Pharmaceuticals Investigational Site
Lipetsk, , Russia
Synta Pharmaceuticals Investigational Site
Moscow, , Russia
Synta Pharmaceuticals Investigational Site
Nizhny Novgorod, , Russia
Synta Pharmaceuticals Investigational Site
Novosibirsk, , Russia
Synta Pharmaceuticals Investigational Site
Omsk, , Russia
Synta Pharmaceuticals Investigational Site
Oryol, , Russia
Synta Pharmaceuticals Investigational Site
Rostov-on-Don, , Russia
Synta Pharmaceuticals Investigational Site
Saint Petersburg, , Russia
Synta Pharmaceuticals Investigational Site
Saint Petersburg, , Russia
Synta Pharmaceuticals Investigational Site
Saint Petersburg, , Russia
Synta Pharmaceuticals Investigational Site
Samara, , Russia
Synta Pharmaceuticals Investigational Site
Saransk, , Russia
Synta Pharmaceuticals Investigational Site
Sochi, , Russia
Synta Pharmaceuticals Investigational Site
Stavropol, , Russia
Synta Pharmaceuticals Investigational Site
Ufa, , Russia
Synta Pharmaceuticals Investigational Site
Ufa, , Russia
Synta Pharmaceuticals Investigational Site
Yekaterinburg, , Russia
Clinical Centre of Serbia
Belgrade, Belgrade, Serbia
Clinical Centre Nis
Niš, Nišavski okrug, Serbia
Institute for Oncology and Radiology of Serbia
Belgrade, , Serbia
Institute for pulmonary diseases of Vojvodine
Kamenitz, , Serbia
Clinical Center Kragujevac
Kragujevac, Šumadijski okrug, Serbia
Univerzitetna klinika za pljucne bolesti in alergijo Golnik
Golnik, , Slovenia
Onkoloski institut Ljubljana
Ljubljana, , Slovenia
Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera
A Coruña, A Coruña, Spain
Synta Pharmaceuticals Investigational Site
Málaga, Andalusia, Spain
H. Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital de Mataró, Consorci Sanitari del Maresme
Mataró, Barcelona, Spain
Synta Pharmaceuticals Investigational Site
Santander, Cantabria, Spain
Onkologikoa
Donostia / San Sebastian, Guipuzcoa, Spain
Synta Pharmaceuticals Investigational Site
Oviedo, Principality of Asturias, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
H.U. Vall d'Hebrón
Barcelona, , Spain
Synta Pharmaceuticals Investigational Site
Barcelona, , Spain
H.U. Reina Sofía
Córdoba, , Spain
Synta Pharmaceuticals Investigational Site
Girona, , Spain
Synta Pharmaceuticals Investigational Site
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Synta Pharmaceuticals Investigational Site
Madrid, , Spain
F. Jiménez Diaz
Madrid, , Spain
Synta Pharmaceuticals Investigational Site
Madrid, , Spain
Hospital Madrid Norte Sanchinarro
Madrid, , Spain
Synta Pharmaceuticals Investigational Site
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Synta Pharmaceuticals Investigational Site
Cherkasy, , Ukraine
Synta Pharmaceuticals Investigational Site
Chernivtsi, , Ukraine
Synta Pharmaceuticals Investigational Site
Dnipro, , Ukraine
Synta Pharmaceuticals Investigational Site
Donetsk, , Ukraine
Synta Pharmaceuticals Investigational Site
Donetsk, , Ukraine
Synta Pharmaceuticals Investigational Site
Ivano-Frankivsk, , Ukraine
Synta Pharmaceuticals Investigative Site
Kharkiv, , Ukraine
Synta Pharmaceuticals Investigational Site
Khmelnytskyi, , Ukraine
Synta Pharmaceuticals Investigational Site
Kirovohrad, , Ukraine
Synta Pharmaceuticals Investigational Site
Kryvyi Rih, , Ukraine
Synta Pharmaceuticals Investigational Site
Kyiv, , Ukraine
Synta Pharmaceuticals Investigational Site
Makiivka, , Ukraine
Synta Pharmaceuticals Investigational Site
Poltava, , Ukraine
Synta Pharmaceuticals Investigational Site
Simferopol, , Ukraine
Synta Pharmaceuticals Investigational Site
Sumy, , Ukraine
Synta Pharmaceuticals Investigational Site
Uzhhorod, , Ukraine
Synta Pharmaceuticals Investigational Site
Vinnytsia, , Ukraine
Synta Pharmaceuticals Investigational Site
Truro, Cornwall, United Kingdom
Synta Pharmaceuticals Investigational Site
Shrewsbury, Shropshire, United Kingdom
Synta Pharmaceuticals Investigational Site
Sutton, Surrey, United Kingdom
Synta Pharmaceuticals Investigational Site
Swindon, Wiltshire, United Kingdom
Synta Pharmaceuticals Investigational Site
Cardiff, , United Kingdom
Synta Pharmaceuticals Investigational Site
Edinburgh, , United Kingdom
Synta Pharmaceuticals Investigational Site
Leicester, , United Kingdom
Synta Pharmaceuticals Investigational Site
London, , United Kingdom
Synta Pharmaceuticals Investigational Site
London, , United Kingdom
Synta Pharmaceuticals Investigational Site
London, , United Kingdom
Synta Pharmaceuticals Investigational Site
Nottingham, , United Kingdom
Synta Pharmaceuticals Investigational Site
Southampton, , United Kingdom
Countries
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Other Identifiers
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2012-004349-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9090-14
Identifier Type: -
Identifier Source: org_study_id
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