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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
Not applicable
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
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Denmark
State/province [28] 0 0
Herlev
Country [29] 0 0
Denmark
State/province [29] 0 0
Odense
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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
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Szolnok
Country [34] 0 0
Hungary
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Szombathely
Country [35] 0 0
Hungary
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Veszprém
Country [36] 0 0
India
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Chennai
Country [37] 0 0
India
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Gurgaon
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India
State/province [38] 0 0
New Delhi
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India
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Trivandrum
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Lecce
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Messina
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Milano
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Napoli
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Italy
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Italy
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Padova
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Italy
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Parma
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Italy
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Rozzano
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San Giovanni Rotondo
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Italy
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Sassari
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Taormina
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Santander
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Sevilla
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Terrassa
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Umeå
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Sweden
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Uppsala
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Taiwan
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Kaohsiung Hsien,
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Tao Yuan Hsien
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United Kingdom
State/province [113] 0 0
Birmingham
Country [114] 0 0
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Bristol
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Glasgow
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Leeds
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London
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Manchester
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Nottingham
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Preston
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Sutton
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Torquay
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Whitechurch
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Wirral

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01254279
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01254279