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

Non-small Cell Lung Cancer Metastatic Clinical Trial

— Galaxy 2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798485
• Other study ID #: 9090-14
• Status: Terminated
• Phase: Phase 3
• First received: February 4, 2013
• Last updated: November 3, 2015
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Austrian Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsBosnia: Federal Ministry of HealthCanada: Health CanadaCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovenia: Agency for Medicinal Products and Medical Devices of the Republic of SloveniaSpain: Agencia Española de Medicamentos y Productos SanitariosUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 696
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced Stage IIIB or IV 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:

• EGFR mutations

• ALK translocations

• Predominantly squamous, adenosquamous or unclear histologic type

• Active or untreated 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Stage IIIB
• Non-small Cell Lung Cancer Stage IV
• Non-Small-Cell Lung Adenocarcinoma

Intervention

Drug:
• Arm A: single agent docetaxel
Single agent docetaxel 75 mg/m2
• Arm B: Combination of ganetespib and docetaxel
ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2

Locations

Country	Name	City	State
Austria	Landesklinikum Krems	Krems	Niederösterreich
Austria	Bezirkskrankenhaus Kufstein [Onkologie]	Kufstein	Tirol
Austria	Allgemeines Krankenhaus Linz	Linz
Austria	Elisabeth Linz Hospital	Linz
Austria	Krankenhaus Der Barmherzigen Schwestern	Linz	Oberösterreich
Austria	Klinikum Wels-Grieskirchen	Wels	Oberösterreich
Austria	Otto Wagner Spital	Wien
Austria	Sozialmedizinisches Zentrum Baumgartner Höhe	Wien
Belgium	Cliniques Universitaire Saint-Luc	Bruxelles
Belgium	Grand Hôpital de Charleroi - Site Notre-Dame	Charleroi	Hainaut
Belgium	INDC Entité Jolimontoise - Polyclinique de Jolimont	Haine St. Paul	Hainaut
Belgium	CHR de la Citadelle - Site Citadelle	Liège
Belgium	AZ Sint-Maarten - Campus Leopoldstraat	Mechelen	Antwerpen
Belgium	Clinique Saint-Pierre Ottignies	Ottignies	Brabant Wallon
Belgium	Algemeen Stedelijk Ziekenhuis - Campus Aalst	Roeselaere	West-Vlaanderen
Belgium	CHU Dinant Godinne UCL Namur	Yvoir	Namur
Bosnia and Herzegovina	Clinical Centre Banja Luka	Banja Luka	Republika Srpska
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	University Clinical Center Tuzla	Tuzla	Tuzlanski kanton
Bosnia and Herzegovina	Kantonalna bolnica Zenica	Zenica
Canada	Mc Gill University-MUHC	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Croatia	Opca bolnica Pula	Pula	Istarska županija
Croatia	University Hospital Center Zagreb	Zagreb	Grad Zagreb
Czech Republic	Fakultni nemocnice Olomouc	Olomouc
Czech Republic	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czech Republic	Nemocnice Na Bulovce	Prague
Czech Republic	Vseobecna fakultni nemocnice v Praze	Prague
France	Centre D'Oncologie Du Pays Basque	Bayonne	Pyrénées-Atlantiques
France	Chi creteil	Creteil	Val-de-Marne
France	CHI des Alpes du Sud	Gap	Hautes-Alpes
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	Centre Hosptalier De Villefranche-Sur-Saone	Villefranche Sur Saone	Rhône
Germany	Gesundheitszentrum Wetterau	Bad Nauheim	Hessen
Germany	MVZ Äerzteforum Seestraße	Berlin
Germany	Ev. Krankenhaus Bielefeld	Bielefeld
Germany	Johann Wolfgang Goethe University Clinic Frankfurt	Frankfurt	Hessen
Germany	Johann Wolfgang Goethe University Clinic Frankfurt	Frankfurt	Hessen
Germany	Klinikum Frankfurt An Der Oder	Frankfurt/Oder
Germany	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Asklepios Fachklinik München-Gauting	Gauting	Bayern
Germany	Pneumologisches Forschungsinstitut an der Lungenclinic Gross	Großhansdorf	Schleswig-Holstein
Germany	Practice Laack	Hamburg
Germany	Universitaetsklinikum des Saarlandes	Homburg	Saarland
Germany	Klinikum Kassel	Kassel	Hessen
Germany	Kliniken der Stadt Köln gGmbH	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Leipzig [Pneumologie]	Leipzig	Sachsen
Germany	Unikl. Schleswig-Holstein - Lübeck	Lübeck
Germany	J. Gutenberg Uni.Mainz	Mainz
Germany	Medizinische Fakultät Mannheim Uni Heidelberg	Mannheim
Germany	Klinikum Bogenhausen	Muenchen	Bayern
Germany	Gemeinschaftspraxis fuer Haematologie und Onkologie	Muenster
Germany	Klinikum Offenbach GmbH	Offenbach
Germany	Universiaetsklinikum Ulm	Ulm	Baden-Württemberg
Germany	Schwarzwald-Baar-Klinikum	Villingen-Schwenningen	Baden-Württemberg
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest	Pest
Hungary	Országos Korányi TBC és Pulmonológiai Intézet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó	Deszk	Csongrád
Hungary	Békés Megyei Pándy Kálmán Kórház	Gyula
Hungary	CRU Hungary Kft.	Miskolc
Hungary	Fejér Megyei Szent György Egyetemi Oktató Kórház	Székesfehérvár	Fejér
Italy	CRO, IRCCS, Istituto Nazionale Tumori	Aviano	Pordenone
Italy	Policlinico S.Orsola Malpighi, AOU di Bologna	Bologna
Italy	AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can	Genova
Italy	Irccs Irst	Meldola	Forli
Italy	Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a	Milano
Italy	Azienda Ospedaliera San Gerardo	Monza	Lombardia
Italy	Iov-Irccs	Padova
Italy	Ospedale S.Maria della Misericordia, AO di Perugia, Universi	Perugia
Italy	Ospedale Guglielmo da Saliceto, AUSL Piacenza	Piacenza
Italy	Istituti Fisioterapici Ospitalieri Regina Elena	Roma
Italy	Azienda Policlinico Umberto I	Rome	Roma
Italy	Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona	Verona
Italy	Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo	Viterbo	Lazio
Netherlands	Ziekenhuis Assen	Assen	Drenthe
Netherlands	Ziekenhuis St Jansdal	Harderwijk	Gelderland
Netherlands	academisch ziekenhuis Maastricht	Maastricht	Limburg
Netherlands	Sint Antoniusziekenhuis, location Utrecht	Utrecht
Netherlands	Gelre Ziekenhuis Zutphen	Zutphen	Gelderland
Netherlands	Isala Klinieken Zwolle	Zwolle	Overijssel
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	Szpital Wojewodzki Zespolony	Elblag	Warminsko-mazurskie
Poland	Medica Pro Familia Sp. z o.o. S.K.A.	Krakow	Malopolskie
Poland	Wojewodzki Szpital Specjalistyczny im. M.Kopernika	Lodz	Lodzkie
Poland	Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego	Lomza	Podlaskie
Poland	Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy	Otwock	Mazowieckie
Poland	Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach	Pilchowice
Poland	NZOZ Med Polonia	Poznan	Wielkopolskie
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii	Poznan	Wielkopolskie
Poland	Szpital Specjalistyczny	Prabuty
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie	Warszawa	Mazowieckie
Romania	Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"	Bucharest
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucharest
Romania	Spitalul Clinic Coltea	Bucuresti
Romania	Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca	Cluj Napoca
Romania	Medisprof	Cluj Napoca
Romania	Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca	Cluj-Napoca
Romania	Centrul de Oncologie Sf. Nectarie	Craiova
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Oncomed	Timisoara
Russian Federation	Synta Pharmaceuticals Investigational Site	Chelyabinsk
Russian Federation	Synta Pharmaceuticals Investigational Site	Ekaterinburg
Russian Federation	Synta Pharmaceuticals Investigational Site	Ivanovo
Russian Federation	Synta Pharmaceuticals Investigational Site	Izhevsk
Russian Federation	Synta Pharmaceuticals Investigational Site	Kemerovo
Russian Federation	Synta Pharmaceuticals Investigational Site	Krasnoyarsk
Russian Federation	Synta Pharmaceuticals Investigational Site	Kursk
Russian Federation	Synta Pharmaceuticals Investigational Site	Lipetsk
Russian Federation	Synta Pharmaceuticals Investigational Site	Moscow
Russian Federation	Synta Pharmaceuticals Investigational Site	Nizhny Novgorod
Russian Federation	Synta Pharmaceuticals Investigational Site	Novosibirsk
Russian Federation	Synta Pharmaceuticals Investigational Site	Omsk
Russian Federation	Synta Pharmaceuticals Investigational Site	Orel
Russian Federation	Synta Pharmaceuticals Investigational Site	Rostov-on-Don
Russian Federation	Synta Pharmaceuticals Investigational Site	Samara
Russian Federation	Synta Pharmaceuticals Investigational Site	Saransk
Russian Federation	Synta Pharmaceuticals Investigational Site	Sochi
Russian Federation	Synta Pharmaceuticals Investigational Site	St. Petersburg
Russian Federation	Synta Pharmaceuticals Investigational Site	St. Petersburg
Russian Federation	Synta Pharmaceuticals Investigational Site	St. Petersburg
Russian Federation	Synta Pharmaceuticals Investigational Site	Stavropol
Russian Federation	Synta Pharmaceuticals Investigational Site	Ufa
Russian Federation	Synta Pharmaceuticals Investigational Site	Ufa
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	Clinical Centre of Serbia	Beograd	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac	Šumadijski okrug
Serbia	Clinical Centre Nis	Nis	Nišavski okrug
Serbia	Institute for pulmonary diseases of Vojvodine	Sremska Kamenica
Slovenia	Univerzitetna klinika za pljucne bolesti in alergijo Golnik	Golnik
Slovenia	Onkoloski institut Ljubljana	Ljubljana
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	Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera	La Coruña	A Coruña
Spain	F. Jiménez Diaz	Madrid
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Synta Pharmaceuticals Investigational Site	Madrid
Spain	Synta Pharmaceuticals Investigational Site	Madrid
Spain	Synta Pharmaceuticals Investigational Site	Madrid
Spain	Synta Pharmaceuticals Investigational Site	Madrid
Spain	Synta Pharmaceuticals Investigational Site	Málaga	Andalucía
Spain	Hospital de Mataró, Consorci Sanitari del Maresme	Mataró	Barcelona
Spain	Synta Pharmaceuticals Investigational Site	Oviedo	Asturias
Spain	H. Son Llàtzer	Palma de Mallorca	Baleares
Spain	Onkologikoa	San Sebastian	Guipuzcoa
Spain	Synta Pharmaceuticals Investigational Site	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Ukraine	Synta Pharmaceuticals Investigational Site	Cherkasy
Ukraine	Synta Pharmaceuticals Investigational Site	Chernivtsi
Ukraine	Synta Pharmaceuticals Investigational Site	Dnepropetrovsk
Ukraine	Synta Pharmaceuticals Investigational Site	Donetsk
Ukraine	Synta Pharmaceuticals Investigational Site	Donetsk
Ukraine	Synta Pharmaceuticals Investigational Site	Ivano-Frankivsk
Ukraine	Synta Pharmaceuticals Investigative Site	Kharkiv
Ukraine	Synta Pharmaceuticals Investigational Site	Khmelnytskyi
Ukraine	Synta Pharmaceuticals Investigational Site	Kirovohrad
Ukraine	Synta Pharmaceuticals Investigational Site	Kryvyi Rih
Ukraine	Synta Pharmaceuticals Investigational Site	Kyiv
Ukraine	Synta Pharmaceuticals Investigational Site	Makiivka
Ukraine	Synta Pharmaceuticals Investigational Site	Poltava
Ukraine	Synta Pharmaceuticals Investigational Site	Simferopol
Ukraine	Synta Pharmaceuticals Investigational Site	Sumy
Ukraine	Synta Pharmaceuticals Investigational Site	Uzhhorod
Ukraine	Synta Pharmaceuticals Investigational Site	Vinnytsia
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	Shrewsbury	Shropshire
United Kingdom	Synta Pharmaceuticals Investigational Site	Southampton
United Kingdom	Synta Pharmaceuticals Investigational Site	Sutton	Surrey
United Kingdom	Synta Pharmaceuticals Investigational Site	Swindon	Wiltshire
United Kingdom	Synta Pharmaceuticals Investigational Site	Truro	Cornwall
United States	New Mexico Cancer Center	Albuquerque	New Mexico
United States	Pacific Cancer Medical Center, Inc	Anaheim	California
United States	AAMC Oncology and Hematology	Annapolis	Maryland
United States	Texas Oncology - Arlington South	Arlington	Texas
United States	Texas Oncology-Arlington North	Arlington	Texas
United States	Emory University - Winship Cancer Institute	Atlanta	Georgia
United States	Comprehensive Blood & Cancer Center	Bakersfield	California
United States	Texas Oncology, P.A.	Beaumont	Texas
United States	The Center for Cancer and Blood Disorders (CCBD) - Bethesda	Bethesda	Maryland
United States	Lynn Cancer Institute Center for Hematology Oncology	Boca Raton	Florida
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	St. Louis Cancer Care, LLP - North County	Bridgeton	Missouri
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	Associates In Oncology and Hematology	Chattanooga	Tennessee
United States	Erlanger Institute for Clinical Research	Chattanooga	Tennessee
United States	University Of Chicago Medical Center	Chicago	Illinois
United States	Simmons Comprehensive Cancer Center	Dallas	Texas
United States	Texas Oncology, PA	Dallas	Texas
United States	Halifax Health - Medical Center	Daytona Beach	Florida
United States	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois
United States	University of Miami Health System Sylvester at Deerfield Beach	Deerfield Beach	Florida
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	City of Hope Comprehensive Breast Cancer Center	Duarte	California
United States	St. Luke's Hospital Duluth	Duluth	Minnesota
United States	North Shore Hematology Oncology Associates	East Setauket	New York
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Arizona Oncology Associates PC- NAHOA	Flagstaff	Arizona
United States	Fort Wayne Medical Oncology and Hematology Inc	Fort Wayne	Indiana
United States	Green Bay Oncology	Green Bay	Wisconsin
United States	Green Bay Oncology, Ltd. - St. Mary's Site	Green Bay	Wisconsin
United States	Hackensack University Medical Center - John Theurer Cancer Center	Hackensack	New Jersey
United States	The John R Marsh Cancer Center	Hagerstown	Maryland
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Houston Methodist Hospital Research Institute	Houston	Texas
United States	Millennium Oncology	Houston	Texas
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Clinical Research Alliance	Lake Success	New York
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	Baptist Health Medical Group Oncology, LLC	Miami	Florida
United States	Mary Babb Cancer Center	Morgantown	West Virginia
United States	Medical Oncology Hematology Consultants, PA	Newark	Delaware
United States	Eastern Connecticut Hematology Associates	Norwich	Connecticut
United States	St. Joseph Hospital, Center for Cancer Prevention and Treatment	Orange	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Arizona Oncology Associates, PC- NAHOA	Prescott Valley	Arizona
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Cancer Care Associates Medical Group, Inc.	Redondo Beach	California
United States	Renown Regional Medical Center	Reno	Nevada
United States	Saint Anthony Medical Center	Rockford	Illinois
United States	UC Davis Medical Center - UC Davis Comprehensive Cancer	Sacramento	California
United States	Frauenshuh Cancer Center	Saint Louis Park	Minnesota
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	Santa Barbara Hematology Oncology Medical Group, Inc.	Santa Barbara	California
United States	Guthrie Medical Group, PC	Sayre	Pennsylvania
United States	Northern Arizona Hematology & Oncology Associates	Sedona	Arizona
United States	Texas Oncology - Sherman	Sherman	Texas
United States	City of Hope- South Pasadena	South Pasadena	California
United States	Cancer Care Northwest	Spokane Valley	Washington
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington
United States	University of South Florida - H. Lee Moffitt	Tampa	Florida
United States	Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Tulsa Cancer Institute, PLLC	Tulsa	Oklahoma
United States	Prairie Lakes Healthcare System	Watertown	South Dakota
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	New Hanover Regional Medical Center - Zimmer Cancer Center	Wilmington	North Carolina
United States	Novant Health Oncology Specialists	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bosnia and Herzegovina,  Canada,  Croatia,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Slovenia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		36 months	No
Secondary	Progression-free survival		36 months	No
Secondary	Objective Response Rate		36 months	No
Secondary	Disease control rate		36 months	No
Secondary	Duration of response		36 months	No
Secondary	Symptom improvement	Symptom improvement will be evaluated based on patient responses to quality of life questionnaires.	36 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		36 months	Yes
Secondary	Exploratory biomarker analyses	Exploratory biomarker analyses will assess correlation between biomarkers and clinical outcome.	36 months	No
Secondary	Emergence of metastatic lesions		36 months	No