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

January 19, 2015 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

984

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To document safety of cabazitaxel in these patients
Time Frame: Up to 35 weeks
Up to 35 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 2, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABAZ_C_05331
  • 2010-021128-92 (EudraCT Number)
  • U1111-1115-2476 (Other Identifier: UTN)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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