## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** CABAZ_C_05331
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**ID:** 2010-021128-92
**Type:** EUDRACT_NUMBER
**Domain:** UTN
**ID:** U1111-1115-2476
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-01-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Start Date
**Date:** 2010-12

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2010-12-06
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-02
**Study First Submit QC Date:** 2010-12-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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.

### Conditions Module

**Conditions:**

- Prostate Cancer Metastatic

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 984

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: CABAZITAXEL

**Label:** Cabazitaxel

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cabazitaxel

**Description:** Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous

**Name:** CABAZITAXEL

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** 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 Outcomes

**Measure:** To document safety of cabazitaxel in these patients

**Time Frame:** Up to 35 weeks

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Box Hill

**Country:** Australia

**Facility:** Investigational Site Number 036004

**Zip:** 3128

**Location 2:**

**City:** Campbelltown

**Country:** Australia

**Facility:** Investigational Site Number 036020

**Zip:** 2560

**Location 3:**

**City:** Camperdown

**Country:** Australia

**Facility:** Investigational Site Number 036001

**Zip:** 2050

**Location 4:**

**City:** Camperdown

**Country:** Australia

**Facility:** Investigational Site Number 036002

**Zip:** 2050

**Location 5:**

**City:** Douglas

**Country:** Australia

**Facility:** Investigational Site Number 036011

**Zip:** 4814

**Location 6:**

**City:** Nambour

**Country:** Australia

**Facility:** Investigational Site Number 036019

**Zip:** 4560

**Location 7:**

**City:** North Adelaide

**Country:** Australia

**Facility:** Investigational Site Number 036023

**Zip:** 5006

**Location 8:**

**City:** Parkville

**Country:** Australia

**Facility:** Investigational Site Number 036008

**Zip:** 3050

**Location 9:**

**City:** Perth

**Country:** Australia

**Facility:** Investigational Site Number 036005

**Location 10:**

**City:** Port Macquarie

**Country:** Australia

**Facility:** Investigational Site Number 036003

**Location 11:**

**City:** Randwick

**Country:** Australia

**Facility:** Investigational Site Number 036025

**Zip:** 2031

**Location 12:**

**City:** South Brisbane

**Country:** Australia

**Facility:** Investigational Site Number 036009

**Zip:** 4101

**Location 13:**

**City:** South Brisbane

**Country:** Australia

**Facility:** Investigational Site Number 036022

**Zip:** 4101

**Location 14:**

**City:** Southport

**Country:** Australia

**Facility:** Investigational Site Number 036017

**Zip:** 4215

**Location 15:**

**City:** St Leonards

**Country:** Australia

**Facility:** Investigational Site Number 036012

**Zip:** 2065

**Location 16:**

**City:** Sydney

**Country:** Australia

**Facility:** Investigational Site Number 036010

**Zip:** 2076

**Location 17:**

**City:** Sydney

**Country:** Australia

**Facility:** Investigational Site Number 036013

**Location 18:**

**City:** Sydney

**Country:** Australia

**Facility:** Investigational Site Number 036014

**Location 19:**

**City:** Tweed Heads

**Country:** Australia

**Facility:** Investigational Site Number 036016

**Location 20:**

**City:** Wendouree

**Country:** Australia

**Facility:** Investigational Site Number 036024

**Zip:** 3355

**Location 21:**

**City:** Westmead

**Country:** Australia

**Facility:** Investigational Site Number 036007

**Zip:** 2145

**Location 22:**

**City:** Wodonga

**Country:** Australia

**Facility:** Investigational Site Number 036015

**Location 23:**

**City:** Linz

**Country:** Austria

**Facility:** Investigational Site Number 040-004

**Zip:** 4010

**Location 24:**

**City:** Salzburg

**Country:** Austria

**Facility:** Investigational Site Number 040-005

**Location 25:**

**City:** Vienna

**Country:** Austria

**Facility:** Investigational Site Number 040-003

**Location 26:**

**City:** Wien

**Country:** Austria

**Facility:** Investigational Site Number 040-002

**Zip:** 1090

**Location 27:**

**City:** Brugge

**Country:** Belgium

**Facility:** Investigational Site Number 056002

**Zip:** 8000

**Location 28:**

**City:** Bruxelles

**Country:** Belgium

**Facility:** Investigational Site Number 056007

**Zip:** 1020

**Location 29:**

**City:** Haine St Paul

**Country:** Belgium

**Facility:** Investigational Site Number 056003

**Zip:** 7100

**Location 30:**

**City:** Liège

**Country:** Belgium

**Facility:** Investigational Site Number 056005

**Zip:** 4000

**Location 31:**

**City:** Ottignies

**Country:** Belgium

**Facility:** Investigational Site Number 056004

**Zip:** 1340

**Location 32:**

**City:** Roeselare

**Country:** Belgium

**Facility:** Investigational Site Number 056001

**Zip:** 8800

**Location 33:**

**City:** Tournai

**Country:** Belgium

**Facility:** Investigational Site Number 056006

**Zip:** 7500

**Location 34:**

**City:** Banja Luka

**Country:** Bosnia and Herzegovina

**Facility:** Investigational Site Number 070003

**Location 35:**

**City:** Sarajevo

**Country:** Bosnia and Herzegovina

**Facility:** Investigational Site Number 070001

**Location 36:**

**City:** Zenica

**Country:** Bosnia and Herzegovina

**Facility:** Investigational Site Number 070002

**Location 37:**

**City:** Plovdiv

**Country:** Bulgaria

**Facility:** Investigational Site Number 100004

**Zip:** 4000

**Location 38:**

**City:** Sofia

**Country:** Bulgaria

**Facility:** Investigational Site Number 100001

**Zip:** 1527

**Location 39:**

**City:** Sofia

**Country:** Bulgaria

**Facility:** Investigational Site Number 100003

**Zip:** 1756

**Location 40:**

**City:** Sofia

**Country:** Bulgaria

**Facility:** Investigational Site Number 100002

**Location 41:**

**City:** Kitchener

**Country:** Canada

**Facility:** Investigational Site Number 124012

**Zip:** N2G1G3

**Location 42:**

**City:** Laval

**Country:** Canada

**Facility:** Investigational Site Number 124009

**Zip:** H7M3L9

**Location 43:**

**City:** London

**Country:** Canada

**Facility:** Investigational Site Number 124004

**Zip:** N6A 4L6

**Location 44:**

**City:** Moncton

**Country:** Canada

**Facility:** Investigational Site Number 124007

**Zip:** E1C6Z8

**Location 45:**

**City:** Montreal

**Country:** Canada

**Facility:** Investigational Site Number 124001

**Zip:** H2L 4M1

**Location 46:**

**City:** Montreal

**Country:** Canada

**Facility:** Investigational Site Number 124011

**Zip:** H3G1A4

**Location 47:**

**City:** Quebec

**Country:** Canada

**Facility:** Investigational Site Number 124010

**Zip:** G1R 2J6

**Location 48:**

**City:** Toronto

**Country:** Canada

**Facility:** Investigational Site Number 124003

**Zip:** M4N3M5

**Location 49:**

**City:** Toronto

**Country:** Canada

**Facility:** Investigational Site Number 124002

**Zip:** M5G2M9

**Location 50:**

**City:** Winnipeg

**Country:** Canada

**Facility:** Investigational Site Number 124006

**Zip:** R3E0V9

**Location 51:**

**City:** Zagreb

**Country:** Croatia

**Facility:** Investigational Site Number 191-001

**Zip:** 10000

**Location 52:**

**City:** Brno

**Country:** Czech Republic

**Facility:** Investigational Site Number 203001

**Zip:** 65653

**Location 53:**

**City:** Cph Ø

**Country:** Denmark

**Facility:** Investigational Site Number 208-001

**Zip:** 2100

**Location 54:**

**City:** Herlev

**Country:** Denmark

**Facility:** Investigational Site Number 208-002

**Zip:** 2730

**Location 55:**

**City:** Odense

**Country:** Denmark

**Facility:** Investigational Site Number 208-003

**Zip:** 5000

**Location 56:**

**City:** Helsinki

**Country:** Finland

**Facility:** Investigational Site Number 246002

**Zip:** 00180

**Location 57:**

**City:** Seinäjoki

**Country:** Finland

**Facility:** Investigational Site Number 246001

**Zip:** 60220

**Location 58:**

**City:** Budapest

**Country:** Hungary

**Facility:** Investigational Site Number 348001

**Zip:** 1032

**Location 59:**

**City:** Szolnok

**Country:** Hungary

**Facility:** Investigational Site Number 348002

**Zip:** 5000

**Location 60:**

**City:** Szombathely

**Country:** Hungary

**Facility:** Investigational Site Number 348003

**Zip:** 9700

**Location 61:**

**City:** Veszprém

**Country:** Hungary

**Facility:** Investigational Site Number 348004

**Zip:** 8200

**Location 62:**

**City:** Chennai

**Country:** India

**Facility:** Investigational Site Number 356004

**Zip:** 600035

**Location 63:**

**City:** Gurgaon

**Country:** India

**Facility:** Investigational Site Number 356006

**Zip:** 12201

**Location 64:**

**City:** New Delhi

**Country:** India

**Facility:** Investigational Site Number 356001

**Zip:** 110029

**Location 65:**

**City:** New Delhi

**Country:** India

**Facility:** Investigational Site Number 356002

**Zip:** 110085

**Location 66:**

**City:** Trivandrum

**Country:** India

**Facility:** Investigational Site Number 356005

**Zip:** 695011

**Location 67:**

**City:** Cork

**Country:** Ireland

**Facility:** Investigational Site Number 372004

**Location 68:**

**City:** Dublin 24

**Country:** Ireland

**Facility:** Investigational Site Number 372003

**Location 69:**

**City:** Dublin 7

**Country:** Ireland

**Facility:** Investigational Site Number 372001

**Location 70:**

**City:** Dublin 7

**Country:** Ireland

**Facility:** Investigational Site Number 372002

**Location 71:**

**City:** Arezzo

**Country:** Italy

**Facility:** Investigational Site Number 380-001

**Zip:** 06156

**Location 72:**

**City:** Aviano

**Country:** Italy

**Facility:** Investigational Site Number 380-011

**Location 73:**

**City:** Bari

**Country:** Italy

**Facility:** Investigational Site Number 380-025

**Location 74:**

**City:** Bergamo

**Country:** Italy

**Facility:** Investigational Site Number 380-007

**Zip:** 24128

**Location 75:**

**City:** Bologna

**Country:** Italy

**Facility:** Investigational Site Number 380-015

**Location 76:**

**City:** Fano

**Country:** Italy

**Facility:** Investigational Site Number 380-021

**Location 77:**

**City:** Firenze

**Country:** Italy

**Facility:** Investigational Site Number 380-012

**Location 78:**

**City:** Genova

**Country:** Italy

**Facility:** Investigational Site Number 380-003

**Zip:** 16132

**Location 79:**

**City:** Genova

**Country:** Italy

**Facility:** Investigational Site Number 380-005

**Zip:** 16132

**Location 80:**

**City:** Lecce

**Country:** Italy

**Facility:** Investigational Site Number 380-014

**Location 81:**

**City:** Messina

**Country:** Italy

**Facility:** Investigational Site Number 380-023

**Location 82:**

**City:** Milano

**Country:** Italy

**Facility:** Investigational Site Number 380-018

**Location 83:**

**City:** Milano

**Country:** Italy

**Facility:** Investigational Site Number 380-022

**Location 84:**

**City:** Napoli

**Country:** Italy

**Facility:** Investigational Site Number 380-006

**Zip:** 80131

**Location 85:**

**City:** Napoli

**Country:** Italy

**Facility:** Investigational Site Number 380-010

**Zip:** 80131

**Location 86:**

**City:** Napoli

**Country:** Italy

**Facility:** Investigational Site Number 380-027

**Location 87:**

**City:** Orbassano

**Country:** Italy

**Facility:** Investigational Site Number 380-004

**Zip:** 10043

**Location 88:**

**City:** Padova

**Country:** Italy

**Facility:** Investigational Site Number 380-017

**Location 89:**

**City:** Parma

**Country:** Italy

**Facility:** Investigational Site Number 380-002

**Zip:** 43100

**Location 90:**

**City:** Roma

**Country:** Italy

**Facility:** Investigational Site Number 380-009

**Zip:** 00152

**Location 91:**

**City:** Roma

**Country:** Italy

**Facility:** Investigational Site Number 380-008

**Zip:** 00189

**Location 92:**

**City:** Rozzano

**Country:** Italy

**Facility:** Investigational Site Number 380-024

**Zip:** 20089

**Location 93:**

**City:** San Giovanni Rotondo

**Country:** Italy

**Facility:** Investigational Site Number 380-020

**Location 94:**

**City:** Sassari

**Country:** Italy

**Facility:** Investigational Site Number 380-013

**Location 95:**

**City:** Taormina

**Country:** Italy

**Facility:** Investigational Site Number 380-016

**Location 96:**

**City:** Almaty

**Country:** Kazakhstan

**Facility:** Investigational Site Number 398001

**Location 97:**

**City:** Shymkent

**Country:** Kazakhstan

**Facility:** Investigational Site Number 398003

**Location 98:**

**City:** Niederkorn

**Country:** Luxembourg

**Facility:** Investigational Site Number 442001

**Zip:** 4602

**Location 99:**

**City:** Georgetown

**Country:** Malaysia

**Facility:** Investigational Site Number 458002

**Zip:** 10050

**Location 100:**

**City:** Kuala Lumpur

**Country:** Malaysia

**Facility:** Investigational Site Number 458001

**Zip:** 59100

**Location 101:**

**City:** Kuching

**Country:** Malaysia

**Facility:** Investigational Site Number 458003

**Zip:** 93586

**Location 102:**

**City:** Durango

**Country:** Mexico

**Facility:** Investigational Site Number 484002

**Zip:** 34000

**Location 103:**

**City:** Irapuato

**Country:** Mexico

**Facility:** Investigational Site Number 484006

**Zip:** 36500

**Location 104:**

**City:** Toluca

**Country:** Mexico

**Facility:** Investigational Site Number 484005

**Zip:** 50180

**Location 105:**

**City:** Zapopan

**Country:** Mexico

**Facility:** Investigational Site Number 484001

**Zip:** 45200

**Location 106:**

**City:** Manila

**Country:** Philippines

**Facility:** Investigational Site Number 608001

**Zip:** 1000

**Location 107:**

**City:** Gdansk

**Country:** Poland

**Facility:** Investigational Site Number 616-001

**Zip:** 80-952

**Location 108:**

**City:** Coimbra

**Country:** Portugal

**Facility:** Investigational Site Number 620002

**Zip:** 3000-75

**Location 109:**

**City:** Lisboa

**Country:** Portugal

**Facility:** Investigational Site Number 620003

**Zip:** 1099-023

**Location 110:**

**City:** Lisboa

**Country:** Portugal

**Facility:** Investigational Site Number 620004

**Zip:** 1649-035

**Location 111:**

**City:** Porto

**Country:** Portugal

**Facility:** Investigational Site Number 620001

**Zip:** 4200-072

**Location 112:**

**City:** Setúbal

**Country:** Portugal

**Facility:** Investigational Site Number 620005

**Zip:** 2910-446

**Location 113:**

**City:** Bucharest

**Country:** Romania

**Facility:** Investigational Site Number 642001

**Zip:** 030171

**Location 114:**

**City:** Cluj-Napoca

**Country:** Romania

**Facility:** Investigational Site Number 642002

**Zip:** 400015

**Location 115:**

**City:** Timisoara

**Country:** Romania

**Facility:** Investigational Site Number 642003

**Zip:** 300239

**Location 116:**

**City:** Belgrade

**Country:** Serbia

**Facility:** Investigational Site Number 688001

**Location 117:**

**City:** Belgrade

**Country:** Serbia

**Facility:** Investigational Site Number 688002

**Location 118:**

**City:** Singapore

**Country:** Singapore

**Facility:** Investigational Site Number 702002

**Zip:** 169610

**Location 119:**

**City:** Singapore

**Country:** Singapore

**Facility:** Investigational Site Number 702001

**Zip:** 258499

**Location 120:**

**City:** Bratislava

**Country:** Slovakia

**Facility:** Investigational Site Number 703001

**Zip:** 83310

**Location 121:**

**City:** Kosice

**Country:** Slovakia

**Facility:** Investigational Site Number 703002

**Zip:** 04190

**Location 122:**

**City:** Barcelona

**Country:** Spain

**Facility:** Investigational Site Number 724018

**Zip:** 08025

**Location 123:**

**City:** Barcelona

**Country:** Spain

**Facility:** Investigational Site Number 724019

**Zip:** 08036

**Location 124:**

**City:** Castellón de la Plana

**Country:** Spain

**Facility:** Investigational Site Number 724023

**Zip:** 12002

**Location 125:**

**City:** Córdoba

**Country:** Spain

**Facility:** Investigational Site Number 724020

**Zip:** 14004

**Location 126:**

**City:** Elche

**Country:** Spain

**Facility:** Investigational Site Number 724025

**Zip:** 03203

**Location 127:**

**City:** Granada

**Country:** Spain

**Facility:** Investigational Site Number 724017

**Zip:** 18014

**Location 128:**

**City:** Guadalajara

**Country:** Spain

**Facility:** Investigational Site Number 724006

**Zip:** 19002

**Location 129:**

**City:** L'Hospitalet de Llobregat

**Country:** Spain

**Facility:** Investigational Site Number 724011

**Zip:** 08907

**Location 130:**

**City:** La Coruña

**Country:** Spain

**Facility:** Investigational Site Number 724002

**Zip:** 15006

**Location 131:**

**City:** León

**Country:** Spain

**Facility:** Investigational Site Number 724010

**Zip:** 24071

**Location 132:**

**City:** Madrid

**Country:** Spain

**Facility:** Investigational Site Number 724003

**Zip:** 28007

**Location 133:**

**City:** Madrid

**Country:** Spain

**Facility:** Investigational Site Number 724012

**Zip:** 28040

**Location 134:**

**City:** Madrid

**Country:** Spain

**Facility:** Investigational Site Number 724007

**Zip:** 28041

**Location 135:**

**City:** Manresa

**Country:** Spain

**Facility:** Investigational Site Number 724008

**Zip:** 08243

**Location 136:**

**City:** Málaga

**Country:** Spain

**Facility:** Investigational Site Number 724021

**Zip:** 29010

**Location 137:**

**City:** Oviedo

**Country:** Spain

**Facility:** Investigational Site Number 724009

**Zip:** 33006

**Location 138:**

**City:** Pamplona

**Country:** Spain

**Facility:** Investigational Site Number 724022

**Zip:** 31008

**Location 139:**

**City:** San Cristóbal de La Laguna - Sta. Cruz de Tenerife

**Country:** Spain

**Facility:** Investigational Site Number 724005

**Zip:** 38320

**Location 140:**

**City:** Santander

**Country:** Spain

**Facility:** Investigational Site Number 724016

**Zip:** 39008

**Location 141:**

**City:** Santiago de Compostela

**Country:** Spain

**Facility:** Investigational Site Number 724015

**Zip:** 15706

**Location 142:**

**City:** Sevilla

**Country:** Spain

**Facility:** Investigational Site Number 724024

**Zip:** 41013

**Location 143:**

**City:** Terrassa

**Country:** Spain

**Facility:** Investigational Site Number 724004

**Zip:** 08221

**Location 144:**

**City:** Valencia

**Country:** Spain

**Facility:** Investigational Site Number 724013

**Zip:** 46009

**Location 145:**

**City:** Valencia

**Country:** Spain

**Facility:** Investigational Site Number 724014

**Zip:** 46015

**Location 146:**

**City:** Zaragoza

**Country:** Spain

**Facility:** Investigational Site Number 724001

**Zip:** 50009

**Location 147:**

**City:** Umeå

**Country:** Sweden

**Facility:** Investigational Site Number 752-002

**Zip:** 90185

**Location 148:**

**City:** Uppsala

**Country:** Sweden

**Facility:** Investigational Site Number 752-001

**Zip:** 75185

**Location 149:**

**City:** Kaohsiung Hsien,

**Country:** Taiwan

**Facility:** Investigational Site Number 005

**Location 150:**

**City:** Taichung

**Country:** Taiwan

**Facility:** Investigational Site Number 004

**Zip:** 407

**Location 151:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Investigational Site Number 002

**Zip:** 100

**Location 152:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Investigational Site Number 003

**Location 153:**

**City:** Tao Yuan Hsien

**Country:** Taiwan

**Facility:** Investigational Site Number 001

**Location 154:**

**City:** Birmingham

**Country:** United Kingdom

**Facility:** Investigational Site Number 826011

**Zip:** B152TH

**Location 155:**

**City:** Bristol

**Country:** United Kingdom

**Facility:** Investigational Site Number 826002

**Zip:** BS28ED

**Location 156:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** Investigational Site Number 826003

**Zip:** G116NT

**Location 157:**

**City:** Leeds

**Country:** United Kingdom

**Facility:** Investigational Site Number 826013

**Zip:** LS97TF

**Location 158:**

**City:** London

**Country:** United Kingdom

**Facility:** Investigational Site Number 826009

**Zip:** SE19RT

**Location 159:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** Investigational Site Number 826012

**Zip:** M204BX

**Location 160:**

**City:** Nottingham

**Country:** United Kingdom

**Facility:** Investigational Site Number 826005

**Zip:** NG51PB

**Location 161:**

**City:** Preston

**Country:** United Kingdom

**Facility:** Investigational Site Number 826008

**Zip:** PR24QF

**Location 162:**

**City:** Sutton

**Country:** United Kingdom

**Facility:** Investigational Site Number 826001

**Zip:** SM25PT

**Location 163:**

**City:** Torquay

**Country:** United Kingdom

**Facility:** Investigational Site Number 826007

**Zip:** TQ27AA

**Location 164:**

**City:** Whitechurch

**Country:** United Kingdom

**Facility:** Investigational Site Number 826006

**Zip:** CF142TL

**Location 165:**

**City:** Wirral

**Country:** United Kingdom

**Facility:** Investigational Site Number 826004

**Zip:** CH634JY

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### References Module

#### 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.

**PMID:** 25639506

**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.

**PMID:** 25001524

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M14121

- Name: Prednisone

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M14120

- Name: Prednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1668

- Name: Docetaxel

- Relevance: LOW

- As Found: Unknown

- ID: M11749

- Name: Methylprednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
