Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
- Registration Number
- NCT01254279
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients.
Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 984
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cabazitaxel CABAZITAXEL Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
- Primary Outcome Measures
Name Time Method To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen Up to 30 weeks
- Secondary Outcome Measures
Name Time Method To document safety of cabazitaxel in these patients Up to 35 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (165)
Investigational Site Number 380-005
🇮🇹Genova, Italy
Investigational Site Number 036002
🇦🇺Camperdown, Australia
Investigational Site Number 036020
🇦🇺Campbelltown, Australia
Investigational Site Number 036004
🇦🇺Box Hill, Australia
Investigational Site Number 036001
🇦🇺Camperdown, Australia
Investigational Site Number 036011
🇦🇺Douglas, Australia
Investigational Site Number 036019
🇦🇺Nambour, Australia
Investigational Site Number 036008
🇦🇺Parkville, Australia
Investigational Site Number 036023
🇦🇺North Adelaide, Australia
Investigational Site Number 036003
🇦🇺Port Macquarie, Australia
Investigational Site Number 036005
🇦🇺Perth, Australia
Investigational Site Number 036025
🇦🇺Randwick, Australia
Investigational Site Number 036009
🇦🇺South Brisbane, Australia
Investigational Site Number 036022
🇦🇺South Brisbane, Australia
Investigational Site Number 036017
🇦🇺Southport, Australia
Investigational Site Number 036012
🇦🇺St Leonards, Australia
Investigational Site Number 036016
🇦🇺Tweed Heads, Australia
Investigational Site Number 036013
🇦🇺Sydney, Australia
Investigational Site Number 036007
🇦🇺Westmead, Australia
Investigational Site Number 036014
🇦🇺Sydney, Australia
Investigational Site Number 036010
🇦🇺Sydney, Australia
Investigational Site Number 036024
🇦🇺Wendouree, Australia
Investigational Site Number 040-005
🇦🇹Salzburg, Austria
Investigational Site Number 040-004
🇦🇹Linz, Austria
Investigational Site Number 036015
🇦🇺Wodonga, Australia
Investigational Site Number 040-003
🇦🇹Vienna, Austria
Investigational Site Number 056002
🇧🇪Brugge, Belgium
Investigational Site Number 056003
🇧🇪Haine St Paul, Belgium
Investigational Site Number 056007
🇧🇪Bruxelles, Belgium
Investigational Site Number 056005
🇧🇪Liège, Belgium
Investigational Site Number 056004
🇧🇪Ottignies, Belgium
Investigational Site Number 056006
🇧🇪Tournai, Belgium
Investigational Site Number 056001
🇧🇪Roeselare, Belgium
Investigational Site Number 100004
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 100001
🇧🇬Sofia, Bulgaria
Investigational Site Number 124009
🇨🇦Laval, Canada
Investigational Site Number 100002
🇧🇬Sofia, Bulgaria
Investigational Site Number 100003
🇧🇬Sofia, Bulgaria
Investigational Site Number 124004
🇨🇦London, Canada
Investigational Site Number 124012
🇨🇦Kitchener, Canada
Investigational Site Number 124001
🇨🇦Montreal, Canada
Investigational Site Number 124007
🇨🇦Moncton, Canada
Investigational Site Number 124011
🇨🇦Montreal, Canada
Investigational Site Number 124003
🇨🇦Toronto, Canada
Investigational Site Number 124010
🇨🇦Quebec, Canada
Investigational Site Number 124002
🇨🇦Toronto, Canada
Investigational Site Number 124006
🇨🇦Winnipeg, Canada
Investigational Site Number 191-001
🇭🇷Zagreb, Croatia
Investigational Site Number 208-002
🇩🇰Herlev, Denmark
Investigational Site Number 246002
🇫🇮Helsinki, Finland
Investigational Site Number 348001
🇭🇺Budapest, Hungary
Investigational Site Number 356004
🇮🇳Chennai, India
Investigational Site Number 348003
🇭🇺Szombathely, Hungary
Investigational Site Number 348002
🇭🇺Szolnok, Hungary
Investigational Site Number 356001
🇮🇳New Delhi, India
Investigational Site Number 356006
🇮🇳Gurgaon, India
Investigational Site Number 372004
🇮🇪Cork, Ireland
Investigational Site Number 356005
🇮🇳Trivandrum, India
Investigational Site Number 372001
🇮🇪Dublin 7, Ireland
Investigational Site Number 380-015
🇮🇹Bologna, Italy
Investigational Site Number 372002
🇮🇪Dublin 7, Ireland
Investigational Site Number 380-001
🇮🇹Arezzo, Italy
Investigational Site Number 380-011
🇮🇹Aviano, Italy
Investigational Site Number 380-025
🇮🇹Bari, Italy
Investigational Site Number 380-007
🇮🇹Bergamo, Italy
Investigational Site Number 380-003
🇮🇹Genova, Italy
Investigational Site Number 380-021
🇮🇹Fano, Italy
Investigational Site Number 380-012
🇮🇹Firenze, Italy
Investigational Site Number 380-014
🇮🇹Lecce, Italy
Investigational Site Number 380-023
🇮🇹Messina, Italy
Investigational Site Number 380-018
🇮🇹Milano, Italy
Investigational Site Number 380-022
🇮🇹Milano, Italy
Investigational Site Number 380-010
🇮🇹Napoli, Italy
Investigational Site Number 380-006
🇮🇹Napoli, Italy
Investigational Site Number 380-027
🇮🇹Napoli, Italy
Investigational Site Number 380-017
🇮🇹Padova, Italy
Investigational Site Number 380-002
🇮🇹Parma, Italy
Investigational Site Number 380-009
🇮🇹Roma, Italy
Investigational Site Number 380-024
🇮🇹Rozzano, Italy
Investigational Site Number 380-008
🇮🇹Roma, Italy
Investigational Site Number 380-013
🇮🇹Sassari, Italy
Investigational Site Number 380-020
🇮🇹San Giovanni Rotondo, Italy
Investigational Site Number 380-016
🇮🇹Taormina, Italy
Investigational Site Number 398001
🇰🇿Almaty, Kazakhstan
Investigational Site Number 398003
🇰🇿Shymkent, Kazakhstan
Investigational Site Number 442001
🇱🇺Niederkorn, Luxembourg
Investigational Site Number 458002
🇲🇾Georgetown, Malaysia
Investigational Site Number 458001
🇲🇾Kuala Lumpur, Malaysia
Investigational Site Number 458003
🇲🇾Kuching, Malaysia
Investigational Site Number 484002
🇲🇽Durango, Mexico
Investigational Site Number 484006
🇲🇽Irapuato, Mexico
Investigational Site Number 484005
🇲🇽Toluca, Mexico
Investigational Site Number 484001
🇲🇽Zapopan, Mexico
Investigational Site Number 608001
🇵🇭Manila, Philippines
Investigational Site Number 616-001
🇵🇱Gdansk, Poland
Investigational Site Number 620002
🇵🇹Coimbra, Portugal
Investigational Site Number 620003
🇵🇹Lisboa, Portugal
Investigational Site Number 620001
🇵🇹Porto, Portugal
Investigational Site Number 620004
🇵🇹Lisboa, Portugal
Investigational Site Number 620005
🇵🇹Setúbal, Portugal
Investigational Site Number 642001
🇷🇴Bucharest, Romania
Investigational Site Number 642002
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 642003
🇷🇴Timisoara, Romania
Investigational Site Number 688001
🇷🇸Belgrade, Serbia
Investigational Site Number 688002
🇷🇸Belgrade, Serbia
Investigational Site Number 702002
🇸🇬Singapore, Singapore
Investigational Site Number 702001
🇸🇬Singapore, Singapore
Investigational Site Number 703001
🇸🇰Bratislava, Slovakia
Investigational Site Number 703002
🇸🇰Kosice, Slovakia
Investigational Site Number 724018
🇪🇸Barcelona, Spain
Investigational Site Number 724019
🇪🇸Barcelona, Spain
Investigational Site Number 724023
🇪🇸Castellón de la Plana, Spain
Investigational Site Number 724020
🇪🇸Córdoba, Spain
Investigational Site Number 724025
🇪🇸Elche, Spain
Investigational Site Number 724017
🇪🇸Granada, Spain
Investigational Site Number 724006
🇪🇸Guadalajara, Spain
Investigational Site Number 724011
🇪🇸L'Hospitalet de Llobregat, Spain
Investigational Site Number 724010
🇪🇸León, Spain
Investigational Site Number 724002
🇪🇸La Coruña, Spain
Investigational Site Number 724003
🇪🇸Madrid, Spain
Investigational Site Number 724013
🇪🇸Valencia, Spain
Investigational Site Number 724007
🇪🇸Madrid, Spain
Investigational Site Number 724012
🇪🇸Madrid, Spain
Investigational Site Number 724014
🇪🇸Valencia, Spain
Investigational Site Number 724008
🇪🇸Manresa, Spain
Investigational Site Number 724021
🇪🇸Málaga, Spain
Investigational Site Number 724022
🇪🇸Pamplona, Spain
Investigational Site Number 724009
🇪🇸Oviedo, Spain
Investigational Site Number 724005
🇪🇸San Cristóbal de La Laguna - Sta. Cruz de Tenerife, Spain
Investigational Site Number 724016
🇪🇸Santander, Spain
Investigational Site Number 724024
🇪🇸Sevilla, Spain
Investigational Site Number 724015
🇪🇸Santiago de Compostela, Spain
Investigational Site Number 724004
🇪🇸Terrassa, Spain
Investigational Site Number 724001
🇪🇸Zaragoza, Spain
Investigational Site Number 752-002
🇸🇪Umeå, Sweden
Investigational Site Number 752-001
🇸🇪Uppsala, Sweden
Investigational Site Number 005
🇨🇳Kaohsiung Hsien,, Taiwan
Investigational Site Number 002
🇨🇳Taipei, Taiwan
Investigational Site Number 004
🇨🇳Taichung, Taiwan
Investigational Site Number 003
🇨🇳Taipei, Taiwan
Investigational Site Number 001
🇨🇳Tao Yuan Hsien, Taiwan
Investigational Site Number 826011
🇬🇧Birmingham, United Kingdom
Investigational Site Number 826002
🇬🇧Bristol, United Kingdom
Investigational Site Number 826003
🇬🇧Glasgow, United Kingdom
Investigational Site Number 826005
🇬🇧Nottingham, United Kingdom
Investigational Site Number 826012
🇬🇧Manchester, United Kingdom
Investigational Site Number 826013
🇬🇧Leeds, United Kingdom
Investigational Site Number 826009
🇬🇧London, United Kingdom
Investigational Site Number 826007
🇬🇧Torquay, United Kingdom
Investigational Site Number 826008
🇬🇧Preston, United Kingdom
Investigational Site Number 826006
🇬🇧Whitechurch, United Kingdom
Investigational Site Number 826004
🇬🇧Wirral, United Kingdom
Investigational Site Number 208-003
🇩🇰Odense, Denmark
Investigational Site Number 208-001
🇩🇰Cph Ø, Denmark
Investigational Site Number 380-004
🇮🇹Orbassano, Italy
Investigational Site Number 826001
🇬🇧Sutton, United Kingdom
Investigational Site Number 348004
🇭🇺Veszprém, Hungary
Investigational Site Number 070001
🇧🇦Sarajevo, Bosnia and Herzegovina
Investigational Site Number 246001
🇫🇮Seinäjoki, Finland
Investigational Site Number 040-002
🇦🇹Wien, Austria
Investigational Site Number 372003
🇮🇪Dublin 24, Ireland
Investigational Site Number 070003
🇧🇦Banja Luka, Bosnia and Herzegovina
Investigational Site Number 070002
🇧🇦Zenica, Bosnia and Herzegovina
Investigational Site Number 203001
🇨🇿Brno, Czech Republic
Investigational Site Number 356002
🇮🇳New Delhi, India