Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
NCT ID: NCT01254279
Last Updated: 2015-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
984 participants
INTERVENTIONAL
2010-12-31
2014-12-31
Brief Summary
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Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cabazitaxel
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous
Interventions
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CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous
Eligibility Criteria
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Inclusion Criteria
* Disease Progression during or after docetaxel-containing regimen for mHRPC
* Surgical or medical castration
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
* Life-expectancy ≥3 months
* Adequate bone marrow, liver, and renal function: Neutrophils\> 1500 /mm3; Hemoglobin \> 10 g/dL; Platelets \> 100 x109/L; Bilirubin \< ULN; SGOT (AST) \< 1.5xULN; SGPT (ALT) \< 1.5xULN; Creatinine \< 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \< 60 mL/min should be excluded.
Exclusion Criteria
* Prior radionuclide therapy (samarium-153, strontium-89, P-32…)
* Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
* Active grade ≥2 peripheral neuropathy
* Active grade ≥2 stomatitis
* Active infection requiring systemic antibiotic or anti-fungal medication
* Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years (except superficial basal cell skin cancer)
* Known brain or leptomeningeal involvement
* History of severe hypersensitivity reaction (≥grade 3) to docetaxel
* History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
* History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone
* Uncontrolled severe illness or medical condition (including uncontrolled cardiac arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed.
* Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5
* Participation in a clinical trial with any investigational drug
* Patient with reproductive potential not implementing accepted and effective method of contraception
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 036004
Box Hill, , Australia
Investigational Site Number 036020
Campbelltown, , Australia
Investigational Site Number 036001
Camperdown, , Australia
Investigational Site Number 036002
Camperdown, , Australia
Investigational Site Number 036011
Douglas, , Australia
Investigational Site Number 036019
Nambour, , Australia
Investigational Site Number 036023
North Adelaide, , Australia
Investigational Site Number 036008
Parkville, , Australia
Investigational Site Number 036005
Perth, , Australia
Investigational Site Number 036003
Port Macquarie, , 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 036010
Sydney, , Australia
Investigational Site Number 036013
Sydney, , Australia
Investigational Site Number 036014
Sydney, , Australia
Investigational Site Number 036016
Tweed Heads, , Australia
Investigational Site Number 036024
Wendouree, , Australia
Investigational Site Number 036007
Westmead, , Australia
Investigational Site Number 036015
Wodonga, , Australia
Investigational Site Number 040-004
Linz, , Austria
Investigational Site Number 040-005
Salzburg, , Austria
Investigational Site Number 040-002
Vienna, , Austria
Investigational Site Number 040-003
Vienna, , Austria
Investigational Site Number 056002
Bruges, , Belgium
Investigational Site Number 056007
Brussels, , Belgium
Investigational Site Number 056003
Haine-Saint-Paul, , Belgium
Investigational Site Number 056005
Liège, , Belgium
Investigational Site Number 056004
Ottignies, , Belgium
Investigational Site Number 056001
Roeselare, , Belgium
Investigational Site Number 056006
Tournai, , Belgium
Investigational Site Number 070003
Banja Luka, , Bosnia and Herzegovina
Investigational Site Number 070001
Sarajevo, , Bosnia and Herzegovina
Investigational Site Number 070002
Zenica, , Bosnia and Herzegovina
Investigational Site Number 100004
Plovdiv, , Bulgaria
Investigational Site Number 100001
Sofia, , Bulgaria
Investigational Site Number 100003
Sofia, , Bulgaria
Investigational Site Number 100002
Sofia, , Bulgaria
Investigational Site Number 124012
Kitchener, , Canada
Investigational Site Number 124009
Laval, , Canada
Investigational Site Number 124004
London, , Canada
Investigational Site Number 124007
Moncton, , Canada
Investigational Site Number 124001
Montreal, , Canada
Investigational Site Number 124011
Montreal, , Canada
Investigational Site Number 124010
Québec, , Canada
Investigational Site Number 124003
Toronto, , Canada
Investigational Site Number 124002
Toronto, , Canada
Investigational Site Number 124006
Winnipeg, , Canada
Investigational Site Number 191-001
Zagreb, , Croatia
Investigational Site Number 203001
Brno, , Czechia
Investigational Site Number 208-001
Cph Ø, , Denmark
Investigational Site Number 208-002
Herlev, , Denmark
Investigational Site Number 208-003
Odense, , Denmark
Investigational Site Number 246002
Helsinki, , Finland
Investigational Site Number 246001
Seinäjoki, , Finland
Investigational Site Number 348001
Budapest, , Hungary
Investigational Site Number 348002
Szolnok, , Hungary
Investigational Site Number 348003
Szombathely, , Hungary
Investigational Site Number 348004
Veszprém, , Hungary
Investigational Site Number 356004
Chennai, , India
Investigational Site Number 356006
Gurgaon, , India
Investigational Site Number 356001
New Delhi, , India
Investigational Site Number 356002
New Delhi, , India
Investigational Site Number 356005
Trivandrum, , India
Investigational Site Number 372004
Cork, , Ireland
Investigational Site Number 372001
Dublin, , Ireland
Investigational Site Number 372002
Dublin, , Ireland
Investigational Site Number 372003
Dublin, , 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 380-015
Bologna, , Italy
Investigational Site Number 380-021
Fano, , Italy
Investigational Site Number 380-012
Florence, , Italy
Investigational Site Number 380-003
Genova, , Italy
Investigational Site Number 380-005
Genova, , Italy
Investigational Site Number 380-014
Lecce, , Italy
Investigational Site Number 380-023
Messina, , Italy
Investigational Site Number 380-018
Milan, , Italy
Investigational Site Number 380-022
Milan, , Italy
Investigational Site Number 380-006
Napoli, , Italy
Investigational Site Number 380-010
Napoli, , Italy
Investigational Site Number 380-027
Napoli, , Italy
Investigational Site Number 380-004
Orbassano, , Italy
Investigational Site Number 380-017
Padua, , Italy
Investigational Site Number 380-002
Parma, , Italy
Investigational Site Number 380-009
Roma, , Italy
Investigational Site Number 380-008
Roma, , Italy
Investigational Site Number 380-024
Rozzano, , Italy
Investigational Site Number 380-020
San Giovanni Rotondo, , Italy
Investigational Site Number 380-013
Sassari, , Italy
Investigational Site Number 380-016
Taormina, , Italy
Investigational Site Number 398001
Almaty, , Kazakhstan
Investigational Site Number 398003
Shymkent, , Kazakhstan
Investigational Site Number 442001
Niedercorn, , Luxembourg
Investigational Site Number 458002
George Town, , 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
Lisbon, , Portugal
Investigational Site Number 620004
Lisbon, , Portugal
Investigational Site Number 620001
Porto, , Portugal
Investigational Site Number 620005
Setúbal, , Portugal
Investigational Site Number 642001
Bucharest, , Romania
Investigational Site Number 642002
Cluj-Napoca, , Romania
Investigational Site Number 642003
Timișoara, , 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
Košice, , Slovakia
Investigational Site Number 724002
A Coruña, , Spain
Investigational Site Number 724018
Barcelona, , Spain
Investigational Site Number 724019
Barcelona, , Spain
Investigational Site Number 724023
Castellon, , 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 724003
Madrid, , Spain
Investigational Site Number 724012
Madrid, , Spain
Investigational Site Number 724007
Madrid, , Spain
Investigational Site Number 724008
Manresa, , Spain
Investigational Site Number 724021
Málaga, , Spain
Investigational Site Number 724009
Oviedo, , Spain
Investigational Site Number 724022
Pamplona, , Spain
Investigational Site Number 724005
San Cristóbal de La Laguna - Santa Cruz de Tenerife, , Spain
Investigational Site Number 724016
Santander, , Spain
Investigational Site Number 724015
Santiago de Compostela, , Spain
Investigational Site Number 724024
Seville, , Spain
Investigational Site Number 724004
Terrassa, , Spain
Investigational Site Number 724013
Valencia, , Spain
Investigational Site Number 724014
Valencia, , 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 004
Taichung, , Taiwan
Investigational Site Number 002
Taipei, , 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 826013
Leeds, , United Kingdom
Investigational Site Number 826009
London, , United Kingdom
Investigational Site Number 826012
Manchester, , United Kingdom
Investigational Site Number 826004
Metropolitan Borough of Wirral, , United Kingdom
Investigational Site Number 826005
Nottingham, , United Kingdom
Investigational Site Number 826008
Preston, , United Kingdom
Investigational Site Number 826001
Sutton, , United Kingdom
Investigational Site Number 826007
Torquay, , United Kingdom
Investigational Site Number 826006
Whitechurch, , United Kingdom
Countries
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References
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Bahl A, Masson S, Malik Z, Birtle AJ, Sundar S, Jones RJ, James ND, Mason MD, Kumar S, Bottomley D, Lydon A, Chowdhury S, Wylie J, de Bono JS. Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279). BJU Int. 2015 Dec;116(6):880-7. doi: 10.1111/bju.13069. Epub 2015 Jun 16.
Castellano D, Anton Aparicio LM, Esteban E, Sanchez-Hernandez A, Germa JR, Batista N, Maroto P, Perez-Valderrama B, Luque R, Mendez-Vidal MJ; cabazitaxel EAP study. Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program. Expert Opin Drug Saf. 2014 Sep;13(9):1165-73. doi: 10.1517/14740338.2014.939583. Epub 2014 Jul 7.
Other Identifiers
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2010-021128-92
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1115-2476
Identifier Type: OTHER
Identifier Source: secondary_id
CABAZ_C_05331
Identifier Type: -
Identifier Source: org_study_id
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