Clinical trial NCT01254279: Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
Official title: Multicentre, Single-arm, Open Label Clinical Trial Intended to Provide Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen and to Document Safety of Cabazitaxel in These Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer Metastatic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 984
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Metastatic Hormone Refractory Prostate Cancer (mHRPC) previously treated with a docetaxel-containing regimen
* 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 radiotherapy to ≥ 40% of bone marrow
* 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.

Primary outcomes:
measure: To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
timeFrame: Up to 30 weeks
Secondary outcomes:
measure: To document safety of cabazitaxel in these patients
timeFrame: Up to 35 weeks
Other outcomes:
Locations:
city: Box Hill
country: Australia
facility: Investigational Site Number 036004
city: Campbelltown
country: Australia
facility: Investigational Site Number 036020
city: Camperdown
country: Australia
facility: Investigational Site Number 036001
city: Camperdown
country: Australia
facility: Investigational Site Number 036002
city: Douglas
country: Australia
facility: Investigational Site Number 036011
city: Nambour
country: Australia
facility: Investigational Site Number 036019
city: North Adelaide
country: Australia
facility: Investigational Site Number 036023
city: Parkville
country: Australia
facility: Investigational Site Number 036008
city: Perth
country: Australia
facility: Investigational Site Number 036005
city: Port Macquarie
country: Australia
facility: Investigational Site Number 036003
city: Randwick
country: Australia
facility: Investigational Site Number 036025
city: South Brisbane
country: Australia
facility: Investigational Site Number 036009
city: South Brisbane
country: Australia
facility: Investigational Site Number 036022
city: Southport
country: Australia
facility: Investigational Site Number 036017
city: St Leonards
country: Australia
facility: Investigational Site Number 036012
city: Sydney
country: Australia
facility: Investigational Site Number 036010
city: Sydney
country: Australia
facility: Investigational Site Number 036013
city: Sydney
country: Australia
facility: Investigational Site Number 036014
city: Tweed Heads
country: Australia
facility: Investigational Site Number 036016
city: Wendouree
country: Australia
facility: Investigational Site Number 036024
city: Westmead
country: Australia
facility: Investigational Site Number 036007
city: Wodonga
country: Australia
facility: Investigational Site Number 036015
city: Linz
country: Austria
facility: Investigational Site Number 040-004
city: Salzburg
country: Austria
facility: Investigational Site Number 040-005
city: Vienna
country: Austria
facility: Investigational Site Number 040-003
city: Wien
country: Austria
facility: Investigational Site Number 040-002
city: Brugge
country: Belgium
facility: Investigational Site Number 056002
city: Bruxelles
country: Belgium
facility: Investigational Site Number 056007
city: Haine St Paul
country: Belgium
facility: Investigational Site Number 056003
city: Liège
country: Belgium
facility: Investigational Site Number 056005
city: Ottignies
country: Belgium
facility: Investigational Site Number 056004
city: Roeselare
country: Belgium
facility: Investigational Site Number 056001
city: Tournai
country: Belgium
facility: Investigational Site Number 056006
city: Banja Luka
country: Bosnia and Herzegovina
facility: Investigational Site Number 070003
city: Sarajevo
country: Bosnia and Herzegovina
facility: Investigational Site Number 070001
city: Zenica
country: Bosnia and Herzegovina
facility: Investigational Site Number 070002
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 100004
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100001
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100003
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100002
city: Kitchener
country: Canada
facility: Investigational Site Number 124012
city: Laval
country: Canada
facility: Investigational Site Number 124009
city: London
country: Canada
facility: Investigational Site Number 124004
city: Moncton
country: Canada
facility: Investigational Site Number 124007
city: Montreal
country: Canada
facility: Investigational Site Number 124001
city: Montreal
country: Canada
facility: Investigational Site Number 124011
city: Quebec
country: Canada
facility: Investigational Site Number 124010
city: Toronto
country: Canada
facility: Investigational Site Number 124003
city: Toronto
country: Canada
facility: Investigational Site Number 124002
city: Winnipeg
country: Canada
facility: Investigational Site Number 124006
city: Zagreb
country: Croatia
facility: Investigational Site Number 191-001
city: Brno
country: Czech Republic
facility: Investigational Site Number 203001
city: Cph Ø
country: Denmark
facility: Investigational Site Number 208-001
city: Herlev
country: Denmark
facility: Investigational Site Number 208-002
city: Odense
country: Denmark
facility: Investigational Site Number 208-003
city: Helsinki
country: Finland
facility: Investigational Site Number 246002
city: Seinäjoki
country: Finland
facility: Investigational Site Number 246001
city: Budapest
country: Hungary
facility: Investigational Site Number 348001
city: Szolnok
country: Hungary
facility: Investigational Site Number 348002
city: Szombathely
country: Hungary
facility: Investigational Site Number 348003
city: Veszprém
country: Hungary
facility: Investigational Site Number 348004
city: Chennai
country: India
facility: Investigational Site Number 356004
city: Gurgaon
country: India
facility: Investigational Site Number 356006
city: New Delhi
country: India
facility: Investigational Site Number 356001
city: New Delhi
country: India
facility: Investigational Site Number 356002
city: Trivandrum
country: India
facility: Investigational Site Number 356005
city: Cork
country: Ireland
facility: Investigational Site Number 372004
city: Dublin 24
country: Ireland
facility: Investigational Site Number 372003
city: Dublin 7
country: Ireland
facility: Investigational Site Number 372001
city: Dublin 7
country: Ireland
facility: Investigational Site Number 372002
city: Arezzo
country: Italy
facility: Investigational Site Number 380-001
city: Aviano
country: Italy
facility: Investigational Site Number 380-011
city: Bari
country: Italy
facility: Investigational Site Number 380-025
city: Bergamo
country: Italy
facility: Investigational Site Number 380-007
city: Bologna
country: Italy
facility: Investigational Site Number 380-015
city: Fano
country: Italy
facility: Investigational Site Number 380-021
city: Firenze
country: Italy
facility: Investigational Site Number 380-012
city: Genova
country: Italy
facility: Investigational Site Number 380-003
city: Genova
country: Italy
facility: Investigational Site Number 380-005
city: Lecce
country: Italy
facility: Investigational Site Number 380-014
city: Messina
country: Italy
facility: Investigational Site Number 380-023
city: Milano
country: Italy
facility: Investigational Site Number 380-018
city: Milano
country: Italy
facility: Investigational Site Number 380-022
city: Napoli
country: Italy
facility: Investigational Site Number 380-006
city: Napoli
country: Italy
facility: Investigational Site Number 380-010
city: Napoli
country: Italy
facility: Investigational Site Number 380-027
city: Orbassano
country: Italy
facility: Investigational Site Number 380-004
city: Padova
country: Italy
facility: Investigational Site Number 380-017
city: Parma
country: Italy
facility: Investigational Site Number 380-002
city: Roma
country: Italy
facility: Investigational Site Number 380-009
city: Roma
country: Italy
facility: Investigational Site Number 380-008
city: Rozzano
country: Italy
facility: Investigational Site Number 380-024
city: San Giovanni Rotondo
country: Italy
facility: Investigational Site Number 380-020
city: Sassari
country: Italy
facility: Investigational Site Number 380-013
city: Taormina
country: Italy
facility: Investigational Site Number 380-016
city: Almaty
country: Kazakhstan
facility: Investigational Site Number 398001
city: Shymkent
country: Kazakhstan
facility: Investigational Site Number 398003
city: Niederkorn
country: Luxembourg
facility: Investigational Site Number 442001
city: Georgetown
country: Malaysia
facility: Investigational Site Number 458002
city: Kuala Lumpur
country: Malaysia
facility: Investigational Site Number 458001
city: Kuching
country: Malaysia
facility: Investigational Site Number 458003
city: Durango
country: Mexico
facility: Investigational Site Number 484002
city: Irapuato
country: Mexico
facility: Investigational Site Number 484006
city: Toluca
country: Mexico
facility: Investigational Site Number 484005
city: Zapopan
country: Mexico
facility: Investigational Site Number 484001
city: Manila
country: Philippines
facility: Investigational Site Number 608001
city: Gdansk
country: Poland
facility: Investigational Site Number 616-001
city: Coimbra
country: Portugal
facility: Investigational Site Number 620002
city: Lisboa
country: Portugal
facility: Investigational Site Number 620003
city: Lisboa
country: Portugal
facility: Investigational Site Number 620004
city: Porto
country: Portugal
facility: Investigational Site Number 620001
city: Setúbal
country: Portugal
facility: Investigational Site Number 620005
city: Bucharest
country: Romania
facility: Investigational Site Number 642001
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642002
city: Timisoara
country: Romania
facility: Investigational Site Number 642003
city: Belgrade
country: Serbia
facility: Investigational Site Number 688001
city: Belgrade
country: Serbia
facility: Investigational Site Number 688002
city: Singapore
country: Singapore
facility: Investigational Site Number 702002
city: Singapore
country: Singapore
facility: Investigational Site Number 702001
city: Bratislava
country: Slovakia
facility: Investigational Site Number 703001
city: Kosice
country: Slovakia
facility: Investigational Site Number 703002
city: Barcelona
country: Spain
facility: Investigational Site Number 724018
city: Barcelona
country: Spain
facility: Investigational Site Number 724019
city: Castellón de la Plana
country: Spain
facility: Investigational Site Number 724023
city: Córdoba
country: Spain
facility: Investigational Site Number 724020
city: Elche
country: Spain
facility: Investigational Site Number 724025
city: Granada
country: Spain
facility: Investigational Site Number 724017
city: Guadalajara
country: Spain
facility: Investigational Site Number 724006
city: L'Hospitalet de Llobregat
country: Spain
facility: Investigational Site Number 724011
city: La Coruña
country: Spain
facility: Investigational Site Number 724002
city: León
country: Spain
facility: Investigational Site Number 724010
city: Madrid
country: Spain
facility: Investigational Site Number 724003
city: Madrid
country: Spain
facility: Investigational Site Number 724012
city: Madrid
country: Spain
facility: Investigational Site Number 724007
city: Manresa
country: Spain
facility: Investigational Site Number 724008
city: Málaga
country: Spain
facility: Investigational Site Number 724021
city: Oviedo
country: Spain
facility: Investigational Site Number 724009
city: Pamplona
country: Spain
facility: Investigational Site Number 724022
city: San Cristóbal de La Laguna - Sta. Cruz de Tenerife
country: Spain
facility: Investigational Site Number 724005
city: Santander
country: Spain
facility: Investigational Site Number 724016
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number 724015
city: Sevilla
country: Spain
facility: Investigational Site Number 724024
city: Terrassa
country: Spain
facility: Investigational Site Number 724004
city: Valencia
country: Spain
facility: Investigational Site Number 724013
city: Valencia
country: Spain
facility: Investigational Site Number 724014
city: Zaragoza
country: Spain
facility: Investigational Site Number 724001
city: Umeå
country: Sweden
facility: Investigational Site Number 752-002
city: Uppsala
country: Sweden
facility: Investigational Site Number 752-001
city: Kaohsiung Hsien,
country: Taiwan
facility: Investigational Site Number 005
city: Taichung
country: Taiwan
facility: Investigational Site Number 004
city: Taipei
country: Taiwan
facility: Investigational Site Number 002
city: Taipei
country: Taiwan
facility: Investigational Site Number 003
city: Tao Yuan Hsien
country: Taiwan
facility: Investigational Site Number 001
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 826011
city: Bristol
country: United Kingdom
facility: Investigational Site Number 826002
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 826003
city: Leeds
country: United Kingdom
facility: Investigational Site Number 826013
city: London
country: United Kingdom
facility: Investigational Site Number 826009
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826012
city: Nottingham
country: United Kingdom
facility: Investigational Site Number 826005
city: Preston
country: United Kingdom
facility: Investigational Site Number 826008
city: Sutton
country: United Kingdom
facility: Investigational Site Number 826001
city: Torquay
country: United Kingdom
facility: Investigational Site Number 826007
city: Whitechurch
country: United Kingdom
facility: Investigational Site Number 826006
city: Wirral
country: United Kingdom
facility: Investigational Site Number 826004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.