Spots Global Cancer Trial Database for Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Official Title: Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
Study ID: NCT01308567
Conditions
Study Description
Brief Summary: Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: * To evaluate safety in the 3 treatment arms. * To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for: * Progression Free Survival (PFS) (RECIST 1.1) * Tumor progression free survival (RECIST 1.1) * Tumor response in participants with measurable disease (RECIST 1.1), * PSA response * PSA-Progression free survival (PSA-PFS). * Pain response in participants with stable pain at baseline * Pain progression free survival * Time to occurrence of any skeletal related events (SRE) * To compare Health-Related Quality of Life (HRQL). * To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.
Detailed Description: Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Investigational Site Number 840004, Muscle Shoals, Alabama, United States
Investigational Site Number 840009, Anaheim, California, United States
Investigational Site Number 840014, Bakersfield, California, United States
Investigational Site Number 840030, Sacramento, California, United States
Investigational Site Number 840003, San Bernardino, California, United States
Investigational Site Number 840012, San Francisco, California, United States
Investigational Site Number 840019, Denver, Colorado, United States
Investigational Site Number 840013, Boca Raton, Florida, United States
Investigational Site Number 840035, Jacksonville, Florida, United States
Investigational Site Number 840001, Port Saint Lucie, Florida, United States
Investigational Site Number 840015, Decatur, Illinois, United States
Investigational Site Number 840018, Wichita, Kansas, United States
Investigational Site Number 840010, Paducah, Kentucky, United States
Investigational Site Number 840008, New Orleans, Louisiana, United States
Investigational Site Number 840006, Rockville, Maryland, United States
Investigational Site Number 840238, Boston, Massachusetts, United States
Investigational Site Number 840138, Boston, Massachusetts, United States
Investigational Site Number 840038, Brookline, Massachusetts, United States
Investigational Site Number 840005, Detroit, Michigan, United States
Investigational Site Number 840021, Saint Louis Park, Minnesota, United States
Investigational Site Number 840016, Kansas City, Missouri, United States
Investigational Site Number 840020, Lincoln, Nebraska, United States
Investigational Site Number 840017, East Orange, New Jersey, United States
Investigational Site Number 840033, Albuquerque, New Mexico, United States
Investigational Site Number 840036, Raleigh, North Carolina, United States
Investigational Site Number 840011, Washington, North Carolina, United States
Investigational Site Number 840026, Akron, Ohio, United States
Investigational Site Number 840023, Cleveland, Ohio, United States
Investigational Site Number 840032, Dunmore, Pennsylvania, United States
Investigational Site Number 840007, Pawtucket, Rhode Island, United States
Investigational Site Number 840037, Myrtle Beach, South Carolina, United States
Investigational Site Number 840028, Chattanooga, Tennessee, United States
Investigational Site Number 036016, Bankstown, , Australia
Investigational Site Number 036008, Camperdown, , Australia
Investigational Site Number 036015, Coffs Harbour, , Australia
Investigational Site Number 036001, Concord, , Australia
Investigational Site Number 036017, Fitzroy, , Australia
Investigational Site Number 036003, Herston, , Australia
Investigational Site Number 036010, Hornsby, , Australia
Investigational Site Number 036012, Kurralta Park, , Australia
Investigational Site Number 036002, Parkville, , Australia
Investigational Site Number 036009, South Brisbane, , Australia
Investigational Site Number 036011, Subiaco, , Australia
Investigational Site Number 036013, Wodonga, , Australia
Investigational Site Number 112001, Minsk, , Belarus
Investigational Site Number 112002, Minsk, , Belarus
Investigational Site Number 112004, Vitebsk, , Belarus
Investigational Site Number 076006, Passo Fundo, , Brazil
Investigational Site Number 076001, Porto Alegre, , Brazil
Investigational Site Number 076002, Porto Alegre, , Brazil
Investigational Site Number 076004, Rio De Janeiro, , Brazil
Investigational Site Number 076009, Sao Jose Do Rio Preto, , Brazil
Investigational Site Number 076005, Sao Paulo, , Brazil
Investigational Site Number 076003, Uberlandia, , Brazil
Investigational Site Number 124002, London, , Canada
Investigational Site Number 124007, Mississauga, , Canada
Investigational Site Number 124005, Moncton, , Canada
Investigational Site Number 124003, Montreal, , Canada
Investigational Site Number 124004, Quebec, , Canada
Investigational Site Number 124006, Toronto, , Canada
Investigational Site Number 156005, Beijing, , China
Investigational Site Number 156002, Shanghai, , China
Investigational Site Number 156003, Shanghai, , China
Investigational Site Number 156004, Shanghai, , China
Investigational Site Number 203002, Brno, , Czechia
Investigational Site Number 203003, Novy Jicin, , Czechia
Investigational Site Number 203001, Olomouc, , Czechia
Investigational Site Number 203004, Praha 2, , Czechia
Investigational Site Number 208002, Herlev, , Denmark
Investigational Site Number 208001, København Ø, , Denmark
Investigational Site Number 208003, Odense C, , Denmark
Investigational Site Number 208004, Ålborg, , Denmark
Investigational Site Number 246002, Helsinki, , Finland
Investigational Site Number 246001, Kuopio, , Finland
Investigational Site Number 246003, Turku, , Finland
Investigational Site Number 250010, Besancon Cedex, , France
Investigational Site Number 250002, Bordeaux Cedex, , France
Investigational Site Number 250006, Caen Cedex 05, , France
Investigational Site Number 250005, Lyon, , France
Investigational Site Number 250003, Paris Cedex 05, , France
Investigational Site Number 250004, Paris Cedex 10, , France
Investigational Site Number 250001, Paris Cedex 15, , France
Investigational Site Number 250007, Poitiers Cedex, , France
Investigational Site Number 250008, Suresnes, , France
Investigational Site Number 250009, Villejuif, , France
Investigational Site Number 276003, Aachen, , Germany
Investigational Site Number 276005, Berlin, , Germany
Investigational Site Number 276001, Düsseldorf, , Germany
Investigational Site Number 276004, Erlangen, , Germany
Investigational Site Number 276002, Homburg, , Germany
Investigational Site Number 276006, München, , Germany
Investigational Site Number 376004, Kfar Saba, , Israel
Investigational Site Number 376003, Petah-Tikva, , Israel
Investigational Site Number 376002, Tel Aviv, , Israel
Investigational Site Number 380001, Arezzo, , Italy
Investigational Site Number 380004, Bari, , Italy
Investigational Site Number 380003, Orbassano, , Italy
Investigational Site Number 380005, Roma, , Italy
Investigational Site Number 380002, Trento, , Italy
Investigational Site Number 392001, Bunkyo-Ku, , Japan
Investigational Site Number 392003, Chiba-Shi, , Japan
Investigational Site Number 392006, Kashiwa-Shi, , Japan
Investigational Site Number 392005, Koto-Ku, , Japan
Investigational Site Number 392002, Osaka Sayama-Shi, , Japan
Investigational Site Number 392004, Osaka-Shi, , Japan
Investigational Site Number 484007, Acapulco, , Mexico
Investigational Site Number 484008, Aguascalientes, , Mexico
Investigational Site Number 484003, D.f., , Mexico
Investigational Site Number 484004, Guadalajara, , Mexico
Investigational Site Number 484009, Merida, , Mexico
Investigational Site Number 484005, Queretaro, , Mexico
Investigational Site Number 484002, San Luis Potosi, , Mexico
Investigational Site Number 484006, Zapopan, , Mexico
Investigational Site Number 604006, Lima, , Peru
Investigational Site Number 604001, Lima, , Peru
Investigational Site Number 604005, Lima, , Peru
Investigational Site Number 604002, Lima, , Peru
Investigational Site Number 616002, Bydgoszcz, , Poland
Investigational Site Number 616001, Gdansk, , Poland
Investigational Site Number 616003, Koscierzyna, , Poland
Investigational Site Number 616005, Lodz, , Poland
Investigational Site Number 616004, Poznan, , Poland
Investigational Site Number 620003, Coimbra, , Portugal
Investigational Site Number 620005, Lisboa, , Portugal
Investigational Site Number 620004, Lisboa, , Portugal
Investigational Site Number 620001, Porto, , Portugal
Investigational Site Number 620002, Porto, , Portugal
Investigational Site Number 642004, Baia Mare, , Romania
Investigational Site Number 642008, Bucharest, , Romania
Investigational Site Number 642005, Bucuresti, , Romania
Investigational Site Number 642002, Cluj Napoca, , Romania
Investigational Site Number 642003, Cluj Napoca, , Romania
Investigational Site Number 642007, Hunedoara, , Romania
Investigational Site Number 643004, Ekaterinburg, , Russian Federation
Investigational Site Number 643008, Moscow, , Russian Federation
Investigational Site Number 643003, Omsk, , Russian Federation
Investigational Site Number 643002, Pyatigorsk, , Russian Federation
Investigational Site Number 643007, Ryazan, , Russian Federation
Investigational Site Number 643005, St-Petersburg, , Russian Federation
Investigational Site Number 643001, Tomsk, , Russian Federation
Investigational Site Number 643006, Yaroslavl, , Russian Federation
Investigational Site Number 724001, Barcelona, , Spain
Investigational Site Number 724007, Barcelona, , Spain
Investigational Site Number 724002, Barcelona, , Spain
Investigational Site Number 724003, Hospitalet De Llobregat, , Spain
Investigational Site Number 724005, Madrid, , Spain
Investigational Site Number 724004, Madrid, , Spain
Investigational Site Number 724006, Santiago De Compostela, , Spain
Investigational Site Number 752003, Malmö, , Sweden
Investigational Site Number 752002, Stockholm, , Sweden
Investigational Site Number 752001, Uppsala, , Sweden
Investigational Site Number 158004, Kaohsiung, , Taiwan
Investigational Site Number 158002, Taichung, , Taiwan
Investigational Site Number 158001, Taipei, , Taiwan
Investigational Site Number 158003, Tao-Yuan, , Taiwan
Investigational Site Number 792002, Ankara, , Turkey
Investigational Site Number 792001, Istanbul, , Turkey
Investigational Site Number 804009, Cherkasy, , Ukraine
Investigational Site Number 804004, Dnipropetrovsk, , Ukraine
Investigational Site Number 804010, Donetsk, , Ukraine
Investigational Site Number 804006, Ivano-Frankivsk, , Ukraine
Investigational Site Number 804003, Kharkov, , Ukraine
Investigational Site Number 804002, Kyiv, , Ukraine
Investigational Site Number 804001, Kyiv, , Ukraine
Investigational Site Number 804007, Lutsk, , Ukraine
Investigational Site Number 804005, Uzhgorod, , Ukraine
Investigational Site Number 804008, Zaporizhzhya, , Ukraine
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
