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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01254279
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: CABAZITAXEL Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 984 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cabazitaxel
Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Drug: CABAZITAXEL
Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous




Primary Outcome Measures :
  1. 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 Measures :
  1. To document safety of cabazitaxel in these patients [ Time Frame: Up to 35 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254279


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Locations
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Australia
Investigational Site Number 036004
Box Hill, Australia, 3128
Investigational Site Number 036020
Campbelltown, Australia, 2560
Investigational Site Number 036001
Camperdown, Australia, 2050
Investigational Site Number 036002
Camperdown, Australia, 2050
Investigational Site Number 036011
Douglas, Australia, 4814
Investigational Site Number 036019
Nambour, Australia, 4560
Investigational Site Number 036023
North Adelaide, Australia, 5006
Investigational Site Number 036008
Parkville, Australia, 3050
Investigational Site Number 036005
Perth, Australia
Investigational Site Number 036003
Port Macquarie, Australia
Investigational Site Number 036025
Randwick, Australia, 2031
Investigational Site Number 036009
South Brisbane, Australia, 4101
Investigational Site Number 036022
South Brisbane, Australia, 4101
Investigational Site Number 036017
Southport, Australia, 4215
Investigational Site Number 036012
St Leonards, Australia, 2065
Investigational Site Number 036010
Sydney, Australia, 2076
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, 3355
Investigational Site Number 036007
Westmead, Australia, 2145
Investigational Site Number 036015
Wodonga, Australia
Austria
Investigational Site Number 040-004
Linz, Austria, 4010
Investigational Site Number 040-005
Salzburg, Austria
Investigational Site Number 040-003
Vienna, Austria
Investigational Site Number 040-002
Wien, Austria, 1090
Belgium
Investigational Site Number 056002
Brugge, Belgium, 8000
Investigational Site Number 056007
Bruxelles, Belgium, 1020
Investigational Site Number 056003
Haine St Paul, Belgium, 7100
Investigational Site Number 056005
Liège, Belgium, 4000
Investigational Site Number 056004
Ottignies, Belgium, 1340
Investigational Site Number 056001
Roeselare, Belgium, 8800
Investigational Site Number 056006
Tournai, Belgium, 7500
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, Bosnia and Herzegovina
Bulgaria
Investigational Site Number 100004
Plovdiv, Bulgaria, 4000
Investigational Site Number 100001
Sofia, Bulgaria, 1527
Investigational Site Number 100003
Sofia, Bulgaria, 1756
Investigational Site Number 100002
Sofia, Bulgaria
Canada
Investigational Site Number 124012
Kitchener, Canada, N2G1G3
Investigational Site Number 124009
Laval, Canada, H7M3L9
Investigational Site Number 124004
London, Canada, N6A 4L6
Investigational Site Number 124007
Moncton, Canada, E1C6Z8
Investigational Site Number 124001
Montreal, Canada, H2L 4M1
Investigational Site Number 124011
Montreal, Canada, H3G1A4
Investigational Site Number 124010
Quebec, Canada, G1R 2J6
Investigational Site Number 124003
Toronto, Canada, M4N3M5
Investigational Site Number 124002
Toronto, Canada, M5G2M9
Investigational Site Number 124006
Winnipeg, Canada, R3E0V9
Croatia
Investigational Site Number 191-001
Zagreb, Croatia, 10000
Czech Republic
Investigational Site Number 203001
Brno, Czech Republic, 65653
Denmark
Investigational Site Number 208-001
Cph Ø, Denmark, 2100
Investigational Site Number 208-002
Herlev, Denmark, 2730
Investigational Site Number 208-003
Odense, Denmark, 5000
Finland
Investigational Site Number 246002
Helsinki, Finland, 00180
Investigational Site Number 246001
Seinäjoki, Finland, 60220
Hungary
Investigational Site Number 348001
Budapest, Hungary, 1032
Investigational Site Number 348002
Szolnok, Hungary, 5000
Investigational Site Number 348003
Szombathely, Hungary, 9700
Investigational Site Number 348004
Veszprém, Hungary, 8200
India
Investigational Site Number 356004
Chennai, India, 600035
Investigational Site Number 356006
Gurgaon, India, 12201
Investigational Site Number 356001
New Delhi, India, 110029
Investigational Site Number 356002
New Delhi, India, 110085
Investigational Site Number 356005
Trivandrum, India, 695011
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, Ireland
Italy
Investigational Site Number 380-001
Arezzo, Italy, 06156
Investigational Site Number 380-011
Aviano, Italy
Investigational Site Number 380-025
Bari, Italy
Investigational Site Number 380-007
Bergamo, Italy, 24128
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, 16132
Investigational Site Number 380-005
Genova, Italy, 16132
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, 80131
Investigational Site Number 380-010
Napoli, Italy, 80131
Investigational Site Number 380-027
Napoli, Italy
Investigational Site Number 380-004
Orbassano, Italy, 10043
Investigational Site Number 380-017
Padova, Italy
Investigational Site Number 380-002
Parma, Italy, 43100
Investigational Site Number 380-009
Roma, Italy, 00152
Investigational Site Number 380-008
Roma, Italy, 00189
Investigational Site Number 380-024
Rozzano, Italy, 20089
Investigational Site Number 380-020
San Giovanni Rotondo, Italy
Investigational Site Number 380-013
Sassari, Italy
Investigational Site Number 380-016
Taormina, Italy
Kazakhstan
Investigational Site Number 398001
Almaty, Kazakhstan
Investigational Site Number 398003
Shymkent, Kazakhstan
Luxembourg
Investigational Site Number 442001
Niederkorn, Luxembourg, 4602
Malaysia
Investigational Site Number 458002
Georgetown, Malaysia, 10050
Investigational Site Number 458001
Kuala Lumpur, Malaysia, 59100
Investigational Site Number 458003
Kuching, Malaysia, 93586
Mexico
Investigational Site Number 484002
Durango, Mexico, 34000
Investigational Site Number 484006
Irapuato, Mexico, 36500
Investigational Site Number 484005
Toluca, Mexico, 50180
Investigational Site Number 484001
Zapopan, Mexico, 45200
Philippines
Investigational Site Number 608001
Manila, Philippines, 1000
Poland
Investigational Site Number 616-001
Gdansk, Poland, 80-952
Portugal
Investigational Site Number 620002
Coimbra, Portugal, 3000-75
Investigational Site Number 620003
Lisboa, Portugal, 1099-023
Investigational Site Number 620004
Lisboa, Portugal, 1649-035
Investigational Site Number 620001
Porto, Portugal, 4200-072
Investigational Site Number 620005
Setúbal, Portugal, 2910-446
Romania
Investigational Site Number 642001
Bucharest, Romania, 030171
Investigational Site Number 642002
Cluj-Napoca, Romania, 400015
Investigational Site Number 642003
Timisoara, Romania, 300239
Serbia
Investigational Site Number 688001
Belgrade, Serbia
Investigational Site Number 688002
Belgrade, Serbia
Singapore
Investigational Site Number 702002
Singapore, Singapore, 169610
Investigational Site Number 702001
Singapore, Singapore, 258499
Slovakia
Investigational Site Number 703001
Bratislava, Slovakia, 83310
Investigational Site Number 703002
Kosice, Slovakia, 04190
Spain
Investigational Site Number 724018
Barcelona, Spain, 08025
Investigational Site Number 724019
Barcelona, Spain, 08036
Investigational Site Number 724023
Castellón de la Plana, Spain, 12002
Investigational Site Number 724020
Córdoba, Spain, 14004
Investigational Site Number 724025
Elche, Spain, 03203
Investigational Site Number 724017
Granada, Spain, 18014
Investigational Site Number 724006
Guadalajara, Spain, 19002
Investigational Site Number 724011
L'Hospitalet de Llobregat, Spain, 08907
Investigational Site Number 724002
La Coruña, Spain, 15006
Investigational Site Number 724010
León, Spain, 24071
Investigational Site Number 724003
Madrid, Spain, 28007
Investigational Site Number 724012
Madrid, Spain, 28040
Investigational Site Number 724007
Madrid, Spain, 28041
Investigational Site Number 724008
Manresa, Spain, 08243
Investigational Site Number 724021
Málaga, Spain, 29010
Investigational Site Number 724009
Oviedo, Spain, 33006
Investigational Site Number 724022
Pamplona, Spain, 31008
Investigational Site Number 724005
San Cristóbal de La Laguna - Sta. Cruz de Tenerife, Spain, 38320
Investigational Site Number 724016
Santander, Spain, 39008
Investigational Site Number 724015
Santiago de Compostela, Spain, 15706
Investigational Site Number 724024
Sevilla, Spain, 41013
Investigational Site Number 724004
Terrassa, Spain, 08221
Investigational Site Number 724013
Valencia, Spain, 46009
Investigational Site Number 724014
Valencia, Spain, 46015
Investigational Site Number 724001
Zaragoza, Spain, 50009
Sweden
Investigational Site Number 752-002
Umeå, Sweden, 90185
Investigational Site Number 752-001
Uppsala, Sweden, 75185
Taiwan
Investigational Site Number 005
Kaohsiung Hsien,, Taiwan
Investigational Site Number 004
Taichung, Taiwan, 407
Investigational Site Number 002
Taipei, Taiwan, 100
Investigational Site Number 003
Taipei, Taiwan
Investigational Site Number 001
Tao Yuan Hsien, Taiwan
United Kingdom
Investigational Site Number 826011
Birmingham, United Kingdom, B152TH
Investigational Site Number 826002
Bristol, United Kingdom, BS28ED
Investigational Site Number 826003
Glasgow, United Kingdom, G116NT
Investigational Site Number 826013
Leeds, United Kingdom, LS97TF
Investigational Site Number 826009
London, United Kingdom, SE19RT
Investigational Site Number 826012
Manchester, United Kingdom, M204BX
Investigational Site Number 826005
Nottingham, United Kingdom, NG51PB
Investigational Site Number 826008
Preston, United Kingdom, PR24QF
Investigational Site Number 826001
Sutton, United Kingdom, SM25PT
Investigational Site Number 826007
Torquay, United Kingdom, TQ27AA
Investigational Site Number 826006
Whitechurch, United Kingdom, CF142TL
Investigational Site Number 826004
Wirral, United Kingdom, CH634JY
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01254279     History of Changes
Other Study ID Numbers: CABAZ_C_05331
2010-021128-92 ( EudraCT Number )
U1111-1115-2476 ( Other Identifier: UTN )
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs