Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01254279




Registration number
NCT01254279
Ethics application status
Date submitted
2/12/2010
Date registered
6/12/2010
Date last updated
21/01/2015

Titles & IDs
Public title
Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
Scientific 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
Secondary ID [1] 0 0
2010-021128-92
Secondary ID [2] 0 0
CABAZ_C_05331
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CABAZITAXEL

Experimental: Cabazitaxel - Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily


Treatment: Drugs: CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
Timepoint [1] 0 0
Up to 30 weeks
Secondary outcome [1] 0 0
To document safety of cabazitaxel in these patients
Timepoint [1] 0 0
Up to 35 weeks

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
984
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036004 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036020 - Campbelltown
Recruitment hospital [3] 0 0
Investigational Site Number 036001 - Camperdown
Recruitment hospital [4] 0 0
Investigational Site Number 036002 - Camperdown
Recruitment hospital [5] 0 0
Investigational Site Number 036011 - Douglas
Recruitment hospital [6] 0 0
Investigational Site Number 036019 - Nambour
Recruitment hospital [7] 0 0
Investigational Site Number 036023 - North Adelaide
Recruitment hospital [8] 0 0
Investigational Site Number 036008 - Parkville
Recruitment hospital [9] 0 0
Investigational Site Number 036005 - Perth
Recruitment hospital [10] 0 0
Investigational Site Number 036003 - Port Macquarie
Recruitment hospital [11] 0 0
Investigational Site Number 036025 - Randwick
Recruitment hospital [12] 0 0
Investigational Site Number 036009 - South Brisbane
Recruitment hospital [13] 0 0
Investigational Site Number 036022 - South Brisbane
Recruitment hospital [14] 0 0
Investigational Site Number 036017 - Southport
Recruitment hospital [15] 0 0
Investigational Site Number 036012 - St Leonards
Recruitment hospital [16] 0 0
Investigational Site Number 036010 - Sydney
Recruitment hospital [17] 0 0
Investigational Site Number 036013 - Sydney
Recruitment hospital [18] 0 0
Investigational Site Number 036014 - Sydney
Recruitment hospital [19] 0 0
Investigational Site Number 036016 - Tweed Heads
Recruitment hospital [20] 0 0
Investigational Site Number 036024 - Wendouree
Recruitment hospital [21] 0 0
Investigational Site Number 036007 - Westmead
Recruitment hospital [22] 0 0
Investigational Site Number 036015 - Wodonga
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
4560 - Nambour
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment postcode(s) [9] 0 0
- Port Macquarie
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment postcode(s) [12] 0 0
4215 - Southport
Recruitment postcode(s) [13] 0 0
2065 - St Leonards
Recruitment postcode(s) [14] 0 0
2076 - Sydney
Recruitment postcode(s) [15] 0 0
- Sydney
Recruitment postcode(s) [16] 0 0
- Tweed Heads
Recruitment postcode(s) [17] 0 0
3355 - Wendouree
Recruitment postcode(s) [18] 0 0
2145 - Westmead
Recruitment postcode(s) [19] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Haine St Paul
Country [8] 0 0
Belgium
State/province [8] 0 0
Liège
Country [9] 0 0
Belgium
State/province [9] 0 0
Ottignies
Country [10] 0 0
Belgium
State/province [10] 0 0
Roeselare
Country [11] 0 0
Belgium
State/province [11] 0 0
Tournai
Country [12] 0 0
Bosnia and Herzegovina
State/province [12] 0 0
Banja Luka
Country [13] 0 0
Bosnia and Herzegovina
State/province [13] 0 0
Sarajevo
Country [14] 0 0
Bosnia and Herzegovina
State/province [14] 0 0
Zenica
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Plovdiv
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofia
Country [17] 0 0
Canada
State/province [17] 0 0
Kitchener
Country [18] 0 0
Canada
State/province [18] 0 0
Laval
Country [19] 0 0
Canada
State/province [19] 0 0
London
Country [20] 0 0
Canada
State/province [20] 0 0
Moncton
Country [21] 0 0
Canada
State/province [21] 0 0
Montreal
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Canada
State/province [23] 0 0
Toronto
Country [24] 0 0
Canada
State/province [24] 0 0
Winnipeg
Country [25] 0 0
Croatia
State/province [25] 0 0
Zagreb
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Brno
Country [27] 0 0
Denmark
State/province [27] 0 0
Cph Ø
Country [28] 0 0
Denmark
State/province [28] 0 0
Herlev
Country [29] 0 0
Denmark
State/province [29] 0 0
Odense
Country [30] 0 0
Finland
State/province [30] 0 0
Helsinki
Country [31] 0 0
Finland
State/province [31] 0 0
Seinäjoki
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Szolnok
Country [34] 0 0
Hungary
State/province [34] 0 0
Szombathely
Country [35] 0 0
Hungary
State/province [35] 0 0
Veszprém
Country [36] 0 0
India
State/province [36] 0 0
Chennai
Country [37] 0 0
India
State/province [37] 0 0
Gurgaon
Country [38] 0 0
India
State/province [38] 0 0
New Delhi
Country [39] 0 0
India
State/province [39] 0 0
Trivandrum
Country [40] 0 0
Ireland
State/province [40] 0 0
Cork
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Ireland
State/province [41] 0 0
Dublin 24
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Ireland
State/province [42] 0 0
Dublin 7
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Italy
State/province [43] 0 0
Arezzo
Country [44] 0 0
Italy
State/province [44] 0 0
Aviano
Country [45] 0 0
Italy
State/province [45] 0 0
Bari
Country [46] 0 0
Italy
State/province [46] 0 0
Bergamo
Country [47] 0 0
Italy
State/province [47] 0 0
Bologna
Country [48] 0 0
Italy
State/province [48] 0 0
Fano
Country [49] 0 0
Italy
State/province [49] 0 0
Firenze
Country [50] 0 0
Italy
State/province [50] 0 0
Genova
Country [51] 0 0
Italy
State/province [51] 0 0
Lecce
Country [52] 0 0
Italy
State/province [52] 0 0
Messina
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Napoli
Country [55] 0 0
Italy
State/province [55] 0 0
Orbassano
Country [56] 0 0
Italy
State/province [56] 0 0
Padova
Country [57] 0 0
Italy
State/province [57] 0 0
Parma
Country [58] 0 0
Italy
State/province [58] 0 0
Roma
Country [59] 0 0
Italy
State/province [59] 0 0
Rozzano
Country [60] 0 0
Italy
State/province [60] 0 0
San Giovanni Rotondo
Country [61] 0 0
Italy
State/province [61] 0 0
Sassari
Country [62] 0 0
Italy
State/province [62] 0 0
Taormina
Country [63] 0 0
Kazakhstan
State/province [63] 0 0
Almaty
Country [64] 0 0
Kazakhstan
State/province [64] 0 0
Shymkent
Country [65] 0 0
Luxembourg
State/province [65] 0 0
Niederkorn
Country [66] 0 0
Malaysia
State/province [66] 0 0
Georgetown
Country [67] 0 0
Malaysia
State/province [67] 0 0
Kuala Lumpur
Country [68] 0 0
Malaysia
State/province [68] 0 0
Kuching
Country [69] 0 0
Mexico
State/province [69] 0 0
Durango
Country [70] 0 0
Mexico
State/province [70] 0 0
Irapuato
Country [71] 0 0
Mexico
State/province [71] 0 0
Toluca
Country [72] 0 0
Mexico
State/province [72] 0 0
Zapopan
Country [73] 0 0
Philippines
State/province [73] 0 0
Manila
Country [74] 0 0
Poland
State/province [74] 0 0
Gdansk
Country [75] 0 0
Portugal
State/province [75] 0 0
Coimbra
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Portugal
State/province [76] 0 0
Lisboa
Country [77] 0 0
Portugal
State/province [77] 0 0
Porto
Country [78] 0 0
Portugal
State/province [78] 0 0
Setúbal
Country [79] 0 0
Romania
State/province [79] 0 0
Bucharest
Country [80] 0 0
Romania
State/province [80] 0 0
Cluj-Napoca
Country [81] 0 0
Romania
State/province [81] 0 0
Timisoara
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Serbia
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Belgrade
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Singapore
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Bratislava
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Barcelona
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Spain
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Castellón de la Plana
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Spain
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Córdoba
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Spain
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Elche
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Spain
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Granada
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Spain
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Guadalajara
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Spain
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L'Hospitalet de Llobregat
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Spain
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La Coruña
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Spain
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León
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Spain
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Madrid
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Spain
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Manresa
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Pamplona
Country [100] 0 0
Spain
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San Cristóbal de La Laguna - Sta. Cruz de Tenerife
Country [101] 0 0
Spain
State/province [101] 0 0
Santander
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Terrassa
Country [105] 0 0
Spain
State/province [105] 0 0
Valencia
Country [106] 0 0
Spain
State/province [106] 0 0
Zaragoza
Country [107] 0 0
Sweden
State/province [107] 0 0
Umeå
Country [108] 0 0
Sweden
State/province [108] 0 0
Uppsala
Country [109] 0 0
Taiwan
State/province [109] 0 0
Kaohsiung Hsien,
Country [110] 0 0
Taiwan
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Taichung
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taipei
Country [112] 0 0
Taiwan
State/province [112] 0 0
Tao Yuan Hsien
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Birmingham
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Bristol
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Glasgow
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
Country [120] 0 0
United Kingdom
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Preston
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United Kingdom
State/province [121] 0 0
Sutton
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United Kingdom
State/province [122] 0 0
Torquay
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Whitechurch
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01254279