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

NCT01254279 | Completed Phase 3

• 3 other identifiers: CABAZ_C_053312010-021128-92U1111-1115-2476
• Study Type: interventional
• Target: 984
• Locations: 27 countries
• Sites: 159

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

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To document safety of cabazitaxel in these patients

  Up to 35 weeks

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

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

Drug: CABAZITAXEL

Interventions

CABAZITAXEL DRUG

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

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (165)

Investigational Site Number 036004

Box Hill, 3128, Australia

Location

Investigational Site Number 036020

Campbelltown, 2560, Australia

Location

Investigational Site Number 036001

Camperdown, 2050, Australia

Location

Investigational Site Number 036002

Camperdown, 2050, Australia

Location

Investigational Site Number 036011

Douglas, 4814, Australia

Location

Investigational Site Number 036019

Nambour, 4560, Australia

Location

Investigational Site Number 036023

North Adelaide, 5006, Australia

Location

Investigational Site Number 036008

Parkville, 3050, Australia

Location

Investigational Site Number 036005

Perth, Australia

Location

Investigational Site Number 036003

Port Macquarie, Australia

Location

Investigational Site Number 036025

Randwick, 2031, Australia

Location

Investigational Site Number 036009

South Brisbane, 4101, Australia

Location

Investigational Site Number 036022

South Brisbane, 4101, Australia

Location

Investigational Site Number 036017

Southport, 4215, Australia

Location

Investigational Site Number 036012

St Leonards, 2065, Australia

Location

Investigational Site Number 036010

Sydney, 2076, Australia

Location

Investigational Site Number 036013

Sydney, Australia

Location

Investigational Site Number 036014

Sydney, Australia

Location

Investigational Site Number 036016

Tweed Heads, Australia

Location

Investigational Site Number 036024

Wendouree, 3355, Australia

Location

Investigational Site Number 036007

Westmead, 2145, Australia

Location

Investigational Site Number 036015

Wodonga, Australia

Location

Investigational Site Number 040-004

Linz, 4010, Austria

Location

Investigational Site Number 040-005

Salzburg, Austria

Location

Investigational Site Number 040-002

Vienna, 1090, Austria

Location

Investigational Site Number 040-003

Vienna, Austria

Location

Investigational Site Number 056002

Bruges, 8000, Belgium

Location

Investigational Site Number 056007

Brussels, 1020, Belgium

Location

Investigational Site Number 056003

Haine-Saint-Paul, 7100, Belgium

Location

Investigational Site Number 056005

Liège, 4000, Belgium

Location

Investigational Site Number 056004

Ottignies, 1340, Belgium

Location

Investigational Site Number 056001

Roeselare, 8800, Belgium

Location

Investigational Site Number 056006

Tournai, 7500, Belgium

Location

Investigational Site Number 070003

Banja Luka, Bosnia and Herzegovina

Location

Investigational Site Number 070001

Sarajevo, Bosnia and Herzegovina

Location

Investigational Site Number 070002

Zenica, Bosnia and Herzegovina

Location

Investigational Site Number 100004

Plovdiv, 4000, Bulgaria

Location

Investigational Site Number 100001

Sofia, 1527, Bulgaria

Location

Investigational Site Number 100003

Sofia, 1756, Bulgaria

Location

Investigational Site Number 100002

Sofia, Bulgaria

Location

Investigational Site Number 124012

Kitchener, N2G1G3, Canada

Location

Investigational Site Number 124009

Laval, H7M3L9, Canada

Location

Investigational Site Number 124004

London, N6A 4L6, Canada

Location

Investigational Site Number 124007

Moncton, E1C6Z8, Canada

Location

Investigational Site Number 124001

Montreal, H2L 4M1, Canada

Location

Investigational Site Number 124011

Montreal, H3G1A4, Canada

Location

Investigational Site Number 124010

Québec, G1R 2J6, Canada

Location

Investigational Site Number 124003

Toronto, M4N3M5, Canada

Location

Investigational Site Number 124002

Toronto, M5G2M9, Canada

Location

Investigational Site Number 124006

Winnipeg, R3E0V9, Canada

Location

Investigational Site Number 191-001

Zagreb, 10000, Croatia

Location

Investigational Site Number 203001

Brno, 65653, Czechia

Location

Investigational Site Number 208-001

Cph Ø, 2100, Denmark

Location

Investigational Site Number 208-002

Herlev, 2730, Denmark

Location

Investigational Site Number 208-003

Odense, 5000, Denmark

Location

Investigational Site Number 246002

Helsinki, 00180, Finland

Location

Investigational Site Number 246001

Seinäjoki, 60220, Finland

Location

Investigational Site Number 348001

Budapest, 1032, Hungary

Location

Investigational Site Number 348002

Szolnok, 5000, Hungary

Location

Investigational Site Number 348003

Szombathely, 9700, Hungary

Location

Investigational Site Number 348004

Veszprém, 8200, Hungary

Location

Investigational Site Number 356004

Chennai, 600035, India

Location

Investigational Site Number 356006

Gūrgaon, 12201, India

Location

Investigational Site Number 356001

New Delhi, 110029, India

Location

Investigational Site Number 356002

New Delhi, 110085, India

Location

Investigational Site Number 356005

Trivandrum, 695011, India

Location

Investigational Site Number 372004

Cork, Ireland

Location

Investigational Site Number 372001

Dublin, Ireland

Location

Investigational Site Number 372002

Dublin, Ireland

Location

Investigational Site Number 372003

Dublin, Ireland

Location

Investigational Site Number 380-001

Arezzo, 06156, Italy

Location

Investigational Site Number 380-011

Aviano, Italy

Location

Investigational Site Number 380-025

Bari, Italy

Location

Investigational Site Number 380-007

Bergamo, 24128, Italy

Location

Investigational Site Number 380-015

Bologna, Italy

Location

Investigational Site Number 380-021

Fano, Italy

Location

Investigational Site Number 380-012

Florence, Italy

Location

Investigational Site Number 380-003

Genova, 16132, Italy

Location

Investigational Site Number 380-005

Genova, 16132, Italy

Location

Investigational Site Number 380-014

Lecce, Italy

Location

Investigational Site Number 380-023

Messina, Italy

Location

Investigational Site Number 380-018

Milan, Italy

Location

Investigational Site Number 380-022

Milan, Italy

Location

Investigational Site Number 380-006

Napoli, 80131, Italy

Location

Investigational Site Number 380-010

Napoli, 80131, Italy

Location

Investigational Site Number 380-027

Napoli, Italy

Location

Investigational Site Number 380-004

Orbassano, 10043, Italy

Location

Investigational Site Number 380-017

Padua, Italy

Location

Investigational Site Number 380-002

Parma, 43100, Italy

Location

Investigational Site Number 380-009

Roma, 00152, Italy

Location

Investigational Site Number 380-008

Roma, 00189, Italy

Location

Investigational Site Number 380-024

Rozzano, 20089, Italy

Location

Investigational Site Number 380-020

San Giovanni Rotondo, Italy

Location

Investigational Site Number 380-013

Sassari, Italy

Location

Investigational Site Number 380-016

Taormina, Italy

Location

Investigational Site Number 398001

Almaty, Kazakhstan

Location

Investigational Site Number 398003

Shymkent, Kazakhstan

Location

Investigational Site Number 442001

Niedercorn, 4602, Luxembourg

Location

Investigational Site Number 458002

George Town, 10050, Malaysia

Location

Investigational Site Number 458001

Kuala Lumpur, 59100, Malaysia

Location

Investigational Site Number 458003

Kuching, 93586, Malaysia

Location

Investigational Site Number 484002

Durango, 34000, Mexico

Location

Investigational Site Number 484006

Irapuato, 36500, Mexico

Location

Investigational Site Number 484005

Toluca, 50180, Mexico

Location

Investigational Site Number 484001

Zapopan, 45200, Mexico

Location

Investigational Site Number 608001

Manila, 1000, Philippines

Location

Investigational Site Number 616-001

Gdansk, 80-952, Poland

Location

Investigational Site Number 620002

Coimbra, 3000-75, Portugal

Location

Investigational Site Number 620003

Lisbon, 1099-023, Portugal

Location

Investigational Site Number 620004

Lisbon, 1649-035, Portugal

Location

Investigational Site Number 620001

Porto, 4200-072, Portugal

Location

Investigational Site Number 620005

Setúbal, 2910-446, Portugal

Location

Investigational Site Number 642001

Bucharest, 030171, Romania

Location

Investigational Site Number 642002

Cluj-Napoca, 400015, Romania

Location

Investigational Site Number 642003

Timișoara, 300239, Romania

Location

Investigational Site Number 688001

Belgrade, Serbia

Location

Investigational Site Number 688002

Belgrade, Serbia

Location

Investigational Site Number 702002

Singapore, 169610, Singapore

Location

Investigational Site Number 702001

Singapore, 258499, Singapore

Location

Investigational Site Number 703001

Bratislava, 83310, Slovakia

Location

Investigational Site Number 703002

Košice, 04190, Slovakia

Location

Investigational Site Number 724002

A Coruña, 15006, Spain

Location

Investigational Site Number 724018

Barcelona, 08025, Spain

Location

Investigational Site Number 724019

Barcelona, 08036, Spain

Location

Investigational Site Number 724023

Castellon, 12002, Spain

Location

Investigational Site Number 724020

Córdoba, 14004, Spain

Location

Investigational Site Number 724025

Elche, 03203, Spain

Location

Investigational Site Number 724017

Granada, 18014, Spain

Location

Investigational Site Number 724006

Guadalajara, 19002, Spain

Location

Investigational Site Number 724011

L'Hospitalet de Llobregat, 08907, Spain

Location

Investigational Site Number 724010

León, 24071, Spain

Location

Investigational Site Number 724003

Madrid, 28007, Spain

Location

Investigational Site Number 724012

Madrid, 28040, Spain

Location

Investigational Site Number 724007

Madrid, 28041, Spain

Location

Investigational Site Number 724008

Manresa, 08243, Spain

Location

Investigational Site Number 724021

Málaga, 29010, Spain

Location

Investigational Site Number 724009

Oviedo, 33006, Spain

Location

Investigational Site Number 724022

Pamplona, 31008, Spain

Location

Investigational Site Number 724005

San Cristóbal de La Laguna - Santa Cruz de Tenerife, 38320, Spain

Location

Investigational Site Number 724016

Santander, 39008, Spain

Location

Investigational Site Number 724015

Santiago de Compostela, 15706, Spain

Location

Investigational Site Number 724024

Seville, 41013, Spain

Location

Investigational Site Number 724004

Terrassa, 08221, Spain

Location

Investigational Site Number 724013

Valencia, 46009, Spain

Location

Investigational Site Number 724014

Valencia, 46015, Spain

Location

Investigational Site Number 724001

Zaragoza, 50009, Spain

Location

Investigational Site Number 752-002

Umeå, 90185, Sweden

Location

Investigational Site Number 752-001

Uppsala, 75185, Sweden

Location

Investigational Site Number 005

Kaohsiung Hsien,, Taiwan

Location

Investigational Site Number 004

Taichung, 407, Taiwan

Location

Investigational Site Number 002

Taipei, 100, Taiwan

Location

Investigational Site Number 003

Taipei, Taiwan

Location

Investigational Site Number 001

Tao Yuan Hsien, Taiwan

Location

Investigational Site Number 826011

Birmingham, B152TH, United Kingdom

Location

Investigational Site Number 826002

Bristol, BS28ED, United Kingdom

Location

Investigational Site Number 826003

Glasgow, G116NT, United Kingdom

Location

Investigational Site Number 826013

Leeds, LS97TF, United Kingdom

Location

Investigational Site Number 826009

London, SE19RT, United Kingdom

Location

Investigational Site Number 826012

Manchester, M204BX, United Kingdom

Location

Investigational Site Number 826004

Metropolitan Borough of Wirral, CH634JY, United Kingdom

Location

Investigational Site Number 826005

Nottingham, NG51PB, United Kingdom

Location

Investigational Site Number 826008

Preston, PR24QF, United Kingdom

Location

Investigational Site Number 826001

Sutton, SM25PT, United Kingdom

Location

Investigational Site Number 826007

Torquay, TQ27AA, United Kingdom

Location

Investigational Site Number 826006

Whitechurch, CF142TL, United Kingdom

Location

Related Publications (2)

• 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 DERIVED

• 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

MeSH Terms

Interventions

cabazitaxel

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

SE (2); FI (2); HU (4); ME (4); PL (1); BO (3); TW (5); PT (5); BE (7); IT (25); AU (22); BU (4); CZ (1); DK (3); KA (2); RO (3); SG (2); CR (1); MY (3); GB (12); ES (25); LU (1); IN (5); SL (2); IE (4); PH (1); CA (10)