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Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Primary Purpose

Prostate Cancer Metastatic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CABAZITAXEL
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 036004
  • Investigational Site Number 036020
  • Investigational Site Number 036001
  • Investigational Site Number 036002
  • Investigational Site Number 036011
  • Investigational Site Number 036019
  • Investigational Site Number 036023
  • Investigational Site Number 036008
  • Investigational Site Number 036005
  • Investigational Site Number 036003
  • Investigational Site Number 036025
  • Investigational Site Number 036009
  • Investigational Site Number 036022
  • Investigational Site Number 036017
  • Investigational Site Number 036012
  • Investigational Site Number 036010
  • Investigational Site Number 036013
  • Investigational Site Number 036014
  • Investigational Site Number 036016
  • Investigational Site Number 036024
  • Investigational Site Number 036007
  • Investigational Site Number 036015
  • Investigational Site Number 040-004
  • Investigational Site Number 040-005
  • Investigational Site Number 040-003
  • Investigational Site Number 040-002
  • Investigational Site Number 056002
  • Investigational Site Number 056007
  • Investigational Site Number 056003
  • Investigational Site Number 056005
  • Investigational Site Number 056004
  • Investigational Site Number 056001
  • Investigational Site Number 056006
  • Investigational Site Number 070003
  • Investigational Site Number 070001
  • Investigational Site Number 070002
  • Investigational Site Number 100004
  • Investigational Site Number 100001
  • Investigational Site Number 100003
  • Investigational Site Number 100002
  • Investigational Site Number 124012
  • Investigational Site Number 124009
  • Investigational Site Number 124004
  • Investigational Site Number 124007
  • Investigational Site Number 124001
  • Investigational Site Number 124011
  • Investigational Site Number 124010
  • Investigational Site Number 124003
  • Investigational Site Number 124002
  • Investigational Site Number 124006
  • Investigational Site Number 191-001
  • Investigational Site Number 203001
  • Investigational Site Number 208-001
  • Investigational Site Number 208-002
  • Investigational Site Number 208-003
  • Investigational Site Number 246002
  • Investigational Site Number 246001
  • Investigational Site Number 348001
  • Investigational Site Number 348002
  • Investigational Site Number 348003
  • Investigational Site Number 348004
  • Investigational Site Number 356004
  • Investigational Site Number 356006
  • Investigational Site Number 356001
  • Investigational Site Number 356002
  • Investigational Site Number 356005
  • Investigational Site Number 372004
  • Investigational Site Number 372003
  • Investigational Site Number 372001
  • Investigational Site Number 372002
  • Investigational Site Number 380-001
  • Investigational Site Number 380-011
  • Investigational Site Number 380-025
  • Investigational Site Number 380-007
  • Investigational Site Number 380-015
  • Investigational Site Number 380-021
  • Investigational Site Number 380-012
  • Investigational Site Number 380-003
  • Investigational Site Number 380-005
  • Investigational Site Number 380-014
  • Investigational Site Number 380-023
  • Investigational Site Number 380-018
  • Investigational Site Number 380-022
  • Investigational Site Number 380-006
  • Investigational Site Number 380-010
  • Investigational Site Number 380-027
  • Investigational Site Number 380-004
  • Investigational Site Number 380-017
  • Investigational Site Number 380-002
  • Investigational Site Number 380-009
  • Investigational Site Number 380-008
  • Investigational Site Number 380-024
  • Investigational Site Number 380-020
  • Investigational Site Number 380-013
  • Investigational Site Number 380-016
  • Investigational Site Number 398001
  • Investigational Site Number 398003
  • Investigational Site Number 442001
  • Investigational Site Number 458002
  • Investigational Site Number 458001
  • Investigational Site Number 458003
  • Investigational Site Number 484002
  • Investigational Site Number 484006
  • Investigational Site Number 484005
  • Investigational Site Number 484001
  • Investigational Site Number 608001
  • Investigational Site Number 616-001
  • Investigational Site Number 620002
  • Investigational Site Number 620003
  • Investigational Site Number 620004
  • Investigational Site Number 620001
  • Investigational Site Number 620005
  • Investigational Site Number 642001
  • Investigational Site Number 642002
  • Investigational Site Number 642003
  • Investigational Site Number 688001
  • Investigational Site Number 688002
  • Investigational Site Number 702002
  • Investigational Site Number 702001
  • Investigational Site Number 703001
  • Investigational Site Number 703002
  • Investigational Site Number 724018
  • Investigational Site Number 724019
  • Investigational Site Number 724023
  • Investigational Site Number 724020
  • Investigational Site Number 724025
  • Investigational Site Number 724017
  • Investigational Site Number 724006
  • Investigational Site Number 724011
  • Investigational Site Number 724002
  • Investigational Site Number 724010
  • Investigational Site Number 724003
  • Investigational Site Number 724012
  • Investigational Site Number 724007
  • Investigational Site Number 724008
  • Investigational Site Number 724021
  • Investigational Site Number 724009
  • Investigational Site Number 724022
  • Investigational Site Number 724005
  • Investigational Site Number 724016
  • Investigational Site Number 724015
  • Investigational Site Number 724024
  • Investigational Site Number 724004
  • Investigational Site Number 724013
  • Investigational Site Number 724014
  • Investigational Site Number 724001
  • Investigational Site Number 752-002
  • Investigational Site Number 752-001
  • Investigational Site Number 005
  • Investigational Site Number 004
  • Investigational Site Number 002
  • Investigational Site Number 003
  • Investigational Site Number 001
  • Investigational Site Number 826011
  • Investigational Site Number 826002
  • Investigational Site Number 826003
  • Investigational Site Number 826013
  • Investigational Site Number 826009
  • Investigational Site Number 826012
  • Investigational Site Number 826005
  • Investigational Site Number 826008
  • Investigational Site Number 826001
  • Investigational Site Number 826007
  • Investigational Site Number 826006
  • Investigational Site Number 826004

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cabazitaxel

Arm Description

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

Outcomes

Primary Outcome Measures

To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen

Secondary Outcome Measures

To document safety of cabazitaxel in these patients

Full Information

First Posted
December 2, 2010
Last Updated
January 19, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01254279
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
984 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Intervention Type
Drug
Intervention Name(s)
CABAZITAXEL
Intervention Description
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous
Primary Outcome Measure Information:
Title
To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
Time Frame
Up to 30 weeks
Secondary Outcome Measure Information:
Title
To document safety of cabazitaxel in these patients
Time Frame
Up to 35 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 036004
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Investigational Site Number 036020
City
Campbelltown
ZIP/Postal Code
2560
Country
Australia
Facility Name
Investigational Site Number 036001
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Investigational Site Number 036002
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Investigational Site Number 036011
City
Douglas
ZIP/Postal Code
4814
Country
Australia
Facility Name
Investigational Site Number 036019
City
Nambour
ZIP/Postal Code
4560
Country
Australia
Facility Name
Investigational Site Number 036023
City
North Adelaide
ZIP/Postal Code
5006
Country
Australia
Facility Name
Investigational Site Number 036008
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Investigational Site Number 036005
City
Perth
Country
Australia
Facility Name
Investigational Site Number 036003
City
Port Macquarie
Country
Australia
Facility Name
Investigational Site Number 036025
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Investigational Site Number 036009
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Investigational Site Number 036022
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Investigational Site Number 036017
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Investigational Site Number 036012
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Investigational Site Number 036010
City
Sydney
ZIP/Postal Code
2076
Country
Australia
Facility Name
Investigational Site Number 036013
City
Sydney
Country
Australia
Facility Name
Investigational Site Number 036014
City
Sydney
Country
Australia
Facility Name
Investigational Site Number 036016
City
Tweed Heads
Country
Australia
Facility Name
Investigational Site Number 036024
City
Wendouree
ZIP/Postal Code
3355
Country
Australia
Facility Name
Investigational Site Number 036007
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Investigational Site Number 036015
City
Wodonga
Country
Australia
Facility Name
Investigational Site Number 040-004
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Investigational Site Number 040-005
City
Salzburg
Country
Austria
Facility Name
Investigational Site Number 040-003
City
Vienna
Country
Austria
Facility Name
Investigational Site Number 040-002
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Investigational Site Number 056002
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Investigational Site Number 056007
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Investigational Site Number 056003
City
Haine St Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Investigational Site Number 056005
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number 056004
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Investigational Site Number 056006
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
Investigational Site Number 070003
City
Banja Luka
Country
Bosnia and Herzegovina
Facility Name
Investigational Site Number 070001
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Investigational Site Number 070002
City
Zenica
Country
Bosnia and Herzegovina
Facility Name
Investigational Site Number 100004
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Investigational Site Number 100001
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Investigational Site Number 100003
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Investigational Site Number 100002
City
Sofia
Country
Bulgaria
Facility Name
Investigational Site Number 124012
City
Kitchener
ZIP/Postal Code
N2G1G3
Country
Canada
Facility Name
Investigational Site Number 124009
City
Laval
ZIP/Postal Code
H7M3L9
Country
Canada
Facility Name
Investigational Site Number 124004
City
London
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Investigational Site Number 124007
City
Moncton
ZIP/Postal Code
E1C6Z8
Country
Canada
Facility Name
Investigational Site Number 124001
City
Montreal
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Investigational Site Number 124011
City
Montreal
ZIP/Postal Code
H3G1A4
Country
Canada
Facility Name
Investigational Site Number 124010
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Investigational Site Number 124003
City
Toronto
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Investigational Site Number 124002
City
Toronto
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Investigational Site Number 124006
City
Winnipeg
ZIP/Postal Code
R3E0V9
Country
Canada
Facility Name
Investigational Site Number 191-001
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigational Site Number 203001
City
Brno
ZIP/Postal Code
65653
Country
Czech Republic
Facility Name
Investigational Site Number 208-001
City
Cph Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Investigational Site Number 208-002
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Investigational Site Number 208-003
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number 246002
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Investigational Site Number 246001
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Investigational Site Number 348001
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Investigational Site Number 348002
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Investigational Site Number 348004
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Investigational Site Number 356004
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Investigational Site Number 356006
City
Gurgaon
ZIP/Postal Code
12201
Country
India
Facility Name
Investigational Site Number 356001
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Investigational Site Number 356002
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Investigational Site Number 356005
City
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
Investigational Site Number 372004
City
Cork
Country
Ireland
Facility Name
Investigational Site Number 372003
City
Dublin 24
Country
Ireland
Facility Name
Investigational Site Number 372001
City
Dublin 7
Country
Ireland
Facility Name
Investigational Site Number 372002
City
Dublin 7
Country
Ireland
Facility Name
Investigational Site Number 380-001
City
Arezzo
ZIP/Postal Code
06156
Country
Italy
Facility Name
Investigational Site Number 380-011
City
Aviano
Country
Italy
Facility Name
Investigational Site Number 380-025
City
Bari
Country
Italy
Facility Name
Investigational Site Number 380-007
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Investigational Site Number 380-015
City
Bologna
Country
Italy
Facility Name
Investigational Site Number 380-021
City
Fano
Country
Italy
Facility Name
Investigational Site Number 380-012
City
Firenze
Country
Italy
Facility Name
Investigational Site Number 380-003
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number 380-005
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number 380-014
City
Lecce
Country
Italy
Facility Name
Investigational Site Number 380-023
City
Messina
Country
Italy
Facility Name
Investigational Site Number 380-018
City
Milano
Country
Italy
Facility Name
Investigational Site Number 380-022
City
Milano
Country
Italy
Facility Name
Investigational Site Number 380-006
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number 380-010
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number 380-027
City
Napoli
Country
Italy
Facility Name
Investigational Site Number 380-004
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Investigational Site Number 380-017
City
Padova
Country
Italy
Facility Name
Investigational Site Number 380-002
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Investigational Site Number 380-009
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Investigational Site Number 380-008
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Investigational Site Number 380-024
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Investigational Site Number 380-020
City
San Giovanni Rotondo
Country
Italy
Facility Name
Investigational Site Number 380-013
City
Sassari
Country
Italy
Facility Name
Investigational Site Number 380-016
City
Taormina
Country
Italy
Facility Name
Investigational Site Number 398001
City
Almaty
Country
Kazakhstan
Facility Name
Investigational Site Number 398003
City
Shymkent
Country
Kazakhstan
Facility Name
Investigational Site Number 442001
City
Niederkorn
ZIP/Postal Code
4602
Country
Luxembourg
Facility Name
Investigational Site Number 458002
City
Georgetown
ZIP/Postal Code
10050
Country
Malaysia
Facility Name
Investigational Site Number 458001
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Investigational Site Number 458003
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Investigational Site Number 484002
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Investigational Site Number 484006
City
Irapuato
ZIP/Postal Code
36500
Country
Mexico
Facility Name
Investigational Site Number 484005
City
Toluca
ZIP/Postal Code
50180
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Zapopan
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Investigational Site Number 608001
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Investigational Site Number 616-001
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Investigational Site Number 620002
City
Coimbra
ZIP/Postal Code
3000-75
Country
Portugal
Facility Name
Investigational Site Number 620003
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Investigational Site Number 620004
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number 620001
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Investigational Site Number 620005
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Investigational Site Number 642001
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Investigational Site Number 642002
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Investigational Site Number 642003
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Investigational Site Number 688001
City
Belgrade
Country
Serbia
Facility Name
Investigational Site Number 688002
City
Belgrade
Country
Serbia
Facility Name
Investigational Site Number 702002
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Investigational Site Number 702001
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Investigational Site Number 703001
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Investigational Site Number 703002
City
Kosice
ZIP/Postal Code
04190
Country
Slovakia
Facility Name
Investigational Site Number 724018
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Investigational Site Number 724019
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724023
City
Castellón de la Plana
ZIP/Postal Code
12002
Country
Spain
Facility Name
Investigational Site Number 724020
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Investigational Site Number 724025
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Investigational Site Number 724017
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Investigational Site Number 724006
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Investigational Site Number 724011
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724002
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number 724010
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Investigational Site Number 724003
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number 724012
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724007
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Investigational Site Number 724008
City
Manresa
ZIP/Postal Code
08243
Country
Spain
Facility Name
Investigational Site Number 724021
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 724009
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Investigational Site Number 724022
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Investigational Site Number 724005
City
San Cristóbal de La Laguna - Sta. Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Investigational Site Number 724016
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Investigational Site Number 724015
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Investigational Site Number 724024
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Investigational Site Number 724004
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Investigational Site Number 724013
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Investigational Site Number 724014
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Investigational Site Number 724001
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Investigational Site Number 752-002
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Investigational Site Number 752-001
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Investigational Site Number 005
City
Kaohsiung Hsien,
Country
Taiwan
Facility Name
Investigational Site Number 004
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Investigational Site Number 002
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigational Site Number 003
City
Taipei
Country
Taiwan
Facility Name
Investigational Site Number 001
City
Tao Yuan Hsien
Country
Taiwan
Facility Name
Investigational Site Number 826011
City
Birmingham
ZIP/Postal Code
B152TH
Country
United Kingdom
Facility Name
Investigational Site Number 826002
City
Bristol
ZIP/Postal Code
BS28ED
Country
United Kingdom
Facility Name
Investigational Site Number 826003
City
Glasgow
ZIP/Postal Code
G116NT
Country
United Kingdom
Facility Name
Investigational Site Number 826013
City
Leeds
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
Investigational Site Number 826009
City
London
ZIP/Postal Code
SE19RT
Country
United Kingdom
Facility Name
Investigational Site Number 826012
City
Manchester
ZIP/Postal Code
M204BX
Country
United Kingdom
Facility Name
Investigational Site Number 826005
City
Nottingham
ZIP/Postal Code
NG51PB
Country
United Kingdom
Facility Name
Investigational Site Number 826008
City
Preston
ZIP/Postal Code
PR24QF
Country
United Kingdom
Facility Name
Investigational Site Number 826001
City
Sutton
ZIP/Postal Code
SM25PT
Country
United Kingdom
Facility Name
Investigational Site Number 826007
City
Torquay
ZIP/Postal Code
TQ27AA
Country
United Kingdom
Facility Name
Investigational Site Number 826006
City
Whitechurch
ZIP/Postal Code
CF142TL
Country
United Kingdom
Facility Name
Investigational Site Number 826004
City
Wirral
ZIP/Postal Code
CH634JY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25639506
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.
Results Reference
derived
PubMed Identifier
25001524
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.
Results Reference
derived

Learn more about this trial

Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

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