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

Prostate Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254279
• Other study ID #: CABAZ_C_05331
• Secondary ID: 2010-021128-92U1
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2010
• Last updated: January 19, 2015
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 984
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Drug:
• CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czech Republic,  Denmark,  Finland,  Hungary,  India,  Ireland,  Italy,  Kazakhstan,  Luxembourg,  Malaysia,  Mexico,  Philippines,  Poland,  Portugal,  Romania,  Serbia,  Singapore,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen		Up to 30 weeks	No
Secondary	To document safety of cabazitaxel in these patients		Up to 35 weeks	Yes