Breast Cancer Clinical Trial
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
Prior therapy defined as 1 prior systemic therapy for advanced disease
Documented disease progression during or following most first line therapy for advanced disease
Adequate hematologic, hepatic, renal function
Exclusion Criteria:
Epidermal growth factor receptor (EGFR) mutations
Anaplastic lymphoma kinase (ALK) translocations
Predominantly squamous, adenosquamous or unclear histologic type
Active or untreated central nervous system (CNS) metastases
Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
Serious cardiac illness or medical conditions
Pregnant or lactating women
Uncontrolled intercurrent illness
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There are 260 Locations for this study
Flagstaff Arizona, 86001, United States
Prescott Valley Arizona, 86314, United States
Sedona Arizona, 86336, United States
Tucson Arizona, 85715, United States
Anaheim California, 92801, United States
Bakersfield California, 93309, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Loma Linda California, 92345, United States
Los Angeles California, 90073, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Redondo Beach California, 90277, United States
Sacramento California, 95817, United States
Santa Barbara California, 93105, United States
South Pasadena California, 91030, United States
Denver Colorado, 80218, United States
Norwich Connecticut, 06360, United States
Newark Delaware, 19713, United States
Boca Raton Florida, 33486, United States
Daytona Beach Florida, 32114, United States
Deerfield Beach Florida, 33442, United States
Hollywood Florida, 33021, United States
Miami Florida, 33176, United States
Tampa Florida, 33612, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30322, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Rockford Illinois, 61108, United States
Fort Wayne Indiana, 46804, United States
Annapolis Maryland, 21401, United States
Bethesda Maryland, 20817, United States
Hagerstown Maryland, 21742, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Lansing Michigan, 48909, United States
Duluth Minnesota, 55805, United States
Saint Louis Park Minnesota, 55426, United States
Bridgeton Missouri, 63044, United States
Reno Nevada, 89502, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87109, United States
East Setauket New York, 11733, United States
Lake Success New York, 11042, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27103, United States
Tulsa Oklahoma, 74146, United States
Portland Oregon, 97227, United States
Pittsburgh Pennsylvania, 15232, United States
Sayre Pennsylvania, 18840, United States
Rapid City South Dakota, 57701, United States
Watertown South Dakota, 57201, United States
Chattanooga Tennessee, 37403, United States
Chattanooga Tennessee, 37421, United States
Knoxville Tennessee, 37916, United States
Arlington Texas, 76012, United States
Arlington Texas, 76014, United States
Beaumont Texas, 77702, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78212, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78258, United States
Sherman Texas, 75090, United States
Everett Washington, 98201, United States
Spokane Valley Washington, 99216, United States
Tacoma Washington, 98405, United States
Morgantown West Virginia, 26506, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Krems Niederösterreich, 3500, Austria
Linz Oberösterreich, 4010, Austria
Wels Oberösterreich, A-460, Austria
Kufstein Tirol, A-633, Austria
Linz , 4021, Austria
Linz , 4021, Austria
Wien , 1140, Austria
Wien , 1145, Austria
Mechelen Antwerpen, 2800, Belgium
Ottignies Brabant Wallon, 1340, Belgium
Charleroi Hainaut, 6000, Belgium
Haine St. Paul Hainaut, 1700, Belgium
Yvoir Namur, 5533, Belgium
Roeselaere West-Vlaanderen, 8800, Belgium
Bruxelles , 1200, Belgium
Liège , 4000, Belgium
Banja Luka Republika Srpska, 78000, Bosnia and Herzegovina
Tuzla Tuzlanski kanton, 75000, Bosnia and Herzegovina
Mostar , 88108, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Tuzla , 75000, Bosnia and Herzegovina
Zenica , 72000, Bosnia and Herzegovina
Toronto Ontario, MG5 2, Canada
Montreal Quebec, H2W 1, Canada
Zagreb Grad Zagreb, 10 00, Croatia
Pula Istarska županija, 52000, Croatia
Olomouc , 775 2, Czech Republic
Ostrava - Poruba , 708 5, Czech Republic
Prague , 128 0, Czech Republic
Prague , 180 8, Czech Republic
Gap Hautes-Alpes, 5000, France
Bayonne Pyrénées-Atlantiques, 64100, France
Villefranche Sur Saone Rhône, 69655, France
Creteil Val-de-Marne, 94010, France
Grenoble , 38700, France
Lyon , 69373, France
Paris , 75679, France
Rennes , 35033, France
Rouen , 76000, France
Strasbourg , 67091, France
Freiburg Baden-Württemberg, 79106, Germany
Ulm Baden-Württemberg, 89081, Germany
Villingen-Schwenningen Baden-Württemberg, 78052, Germany
Gauting Bayern, 82131, Germany
Muenchen Bayern, 81925, Germany
Bad Nauheim Hessen, 61231, Germany
Frankfurt Hessen, 60590, Germany
Frankfurt Hessen, D-605, Germany
Kassel Hessen, 34125, Germany
Köln Nordrhein-Westfalen, 51109, Germany
Homburg Saarland, 66421, Germany
Leipzig Sachsen, 04103, Germany
Großhansdorf Schleswig-Holstein, 22927, Germany
Berlin , 13347, Germany
Bielefeld , 33611, Germany
Frankfurt/Oder , 15236, Germany
Hamburg , 20251, Germany
Lübeck , 23538, Germany
Mainz , 55101, Germany
Mannheim , 68167, Germany
Muenster , 48149, Germany
Offenbach , 63069, Germany
Deszk Csongrád, 6772, Hungary
Székesfehérvár Fejér, 8000, Hungary
Budapest Pest, 1145, Hungary
Budapest , 1125, Hungary
Budapest , 1529, Hungary
Gyula , 5703, Hungary
Miskolc , 3529, Hungary
Meldola Forli, 47014, Italy
Viterbo Lazio, 01100, Italy
Monza Lombardia, 20900, Italy
Aviano Pordenone, 33081, Italy
Rome Roma, 00161, Italy
Bologna , 40138, Italy
Genova , 16132, Italy
Milano , 20141, Italy
Padova , 35128, Italy
Perugia , 06156, Italy
Piacenza , 29100, Italy
Roma , 00144, Italy
Verona , 37134, Italy
Assen Drenthe, 9401 , Netherlands
Harderwijk Gelderland, 3844 , Netherlands
Zutphen Gelderland, 7207 , Netherlands
Maastricht Limburg, 6229 , Netherlands
Zwolle Overijssel, 8025 , Netherlands
Utrecht , 3543 , Netherlands
Lodz Lodzkie, 93-51, Poland
Krakow Malopolskie, 31-00, Poland
Otwock Mazowieckie, 05-40, Poland
Warszawa Mazowieckie, 02-78, Poland
Bialystok Podlaskie, 15-54, Poland
Lomza Podlaskie, 18-40, Poland
Elblag Warminsko-mazurskie, 82-30, Poland
Poznan Wielkopolskie, 60-69, Poland
Poznan Wielkopolskie, 60569, Poland
Olsztyn , 10-35, Poland
Pilchowice , 44145, Poland
Prabuty , 82-55, Poland
Bucharest , 02232, Romania
Bucharest , 05009, Romania
Bucuresti , 03017, Romania
Cluj Napoca , 40001, Romania
Cluj Napoca , 40005, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20038, Romania
Iasi , 70048, Romania
Timisoara , 30023, Romania
Chelyabinsk , 45408, Russian Federation
Ekaterinburg , 62003, Russian Federation
Ivanovo , 15304, Russian Federation
Izhevsk , 42606, Russian Federation
Kemerovo , 65003, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Kursk , 30503, Russian Federation
Lipetsk , 39800, Russian Federation
Moscow , 11547, Russian Federation
Nizhny Novgorod , 60308, Russian Federation
Novosibirsk , 63004, Russian Federation
Omsk , 64401, Russian Federation
Orel , 30202, Russian Federation
Rostov-on-Don , 34403, Russian Federation
Samara , 44303, Russian Federation
Saransk , 43003, Russian Federation
Sochi , 35405, Russian Federation
St. Petersburg , 19401, Russian Federation
St. Petersburg , 19775, Russian Federation
St. Petersburg , 19825, Russian Federation
Stavropol , 35504, Russian Federation
Ufa , 45000, Russian Federation
Ufa , 45005, Russian Federation
Beograd Belgrade, 11000, Serbia
Nis Nišavski okrug, 18000, Serbia
Belgrade , 11000, Serbia
Sremska Kamenica , 21204, Serbia
Kragujevac Å umadijski okrug, 34 00, Serbia
Golnik , 4204, Slovenia
Ljubljana , 1000, Slovenia
La Coruña A Coruña, 15006, Spain
Málaga AndalucÃa, 29010, Spain
Oviedo Asturias, 33006, Spain
Palma de Mallorca Baleares, 07198, Spain
Mataró Barcelona, 08304, Spain
Santander Cantabria, 39008, Spain
San Sebastian Guipuzcoa, 20014, Spain
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Córdoba , 14004, Spain
Girona , 17007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Sevilla , 41013, Spain
Valencia , 46002, Spain
Cherkasy , 18009, Ukraine
Chernivtsi , 58013, Ukraine
Dnepropetrovsk , 49102, Ukraine
Donetsk , 83087, Ukraine
Donetsk , 83092, Ukraine
Ivano-Frankivsk , 76000, Ukraine
Kharkiv , 61070, Ukraine
Khmelnytskyi , 29009, Ukraine
Kirovohrad , 25011, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03115, Ukraine
Makiivka , 86120, Ukraine
Poltava , 36011, Ukraine
Simferopol , 95023, Ukraine
Sumy , 40022, Ukraine
Uzhhorod , 88014, Ukraine
Vinnytsia , 21021, Ukraine
Truro Cornwall, TR1 3, United Kingdom
Shrewsbury Shropshire, SY3 8, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Swindon Wiltshire, SN3 6, United Kingdom
Cardiff , CF14 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Leicester , LEI 5, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
London , W6 8R, United Kingdom
Nottingham , NG5 1, United Kingdom
Southampton , SO16 , United Kingdom
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