AzTrials
AzTrials

Prostate Cancer MetastaticPhase 3NCT01254279

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

A Phase 3 study testing CABAZITAXEL in people with Prostate Cancer Metastatic, run by Sanofi at 165 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
CABAZITAXEL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
984 participants
Where
165 sitesin 29 countries
Study dates
Dec 2010to Dec 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

165 sites in 29 countries.

165 sites in 29 countries

Italy25 sites

  • Investigational Site Number 380-001

    Arezzo, 06156

  • Investigational Site Number 380-011

    Aviano

  • Investigational Site Number 380-025

    Bari

  • Investigational Site Number 380-007

    Bergamo, 24128

  • Investigational Site Number 380-015

    Bologna

  • Investigational Site Number 380-021

    Fano

  • Investigational Site Number 380-012

    Florence

  • Investigational Site Number 380-003

    Genova, 16132

  • Investigational Site Number 380-005

    Genova, 16132

  • Investigational Site Number 380-014

    Lecce

  • Investigational Site Number 380-023

    Messina

  • Investigational Site Number 380-018

    Milan

  • Investigational Site Number 380-022

    Milan

  • Investigational Site Number 380-006

    Naples, 80131

  • Investigational Site Number 380-010

    Naples, 80131

  • Investigational Site Number 380-027

    Naples

  • Investigational Site Number 380-004

    Orbassano, 10043

  • Investigational Site Number 380-017

    Padova

  • Investigational Site Number 380-002

    Parma, 43100

  • Investigational Site Number 380-009

    Roma, 00152

  • Investigational Site Number 380-008

    Roma, 00189

  • Investigational Site Number 380-024

    Rozzano, 20089

  • Investigational Site Number 380-020

    San Giovanni Rotondo

  • Investigational Site Number 380-013

    Sassari

  • Investigational Site Number 380-016

    Taormina

Other trials in Italy

Spain25 sites

  • Investigational Site Number 724002

    A Coruña, 15006

  • Investigational Site Number 724018

    Barcelona, 08025

  • Investigational Site Number 724019

    Barcelona, 08036

  • Investigational Site Number 724023

    Castellon, 12002

  • Investigational Site Number 724020

    Córdoba, 14004

  • Investigational Site Number 724025

    Elche, 03203

  • Investigational Site Number 724017

    Granada, 18014

  • Investigational Site Number 724006

    Guadalajara, 19002

  • Investigational Site Number 724011

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 724010

    León, 24071

  • Investigational Site Number 724003

    Madrid, 28007

  • Investigational Site Number 724012

    Madrid, 28040

  • Investigational Site Number 724007

    Madrid, 28041

  • Investigational Site Number 724021

    Málaga, 29010

  • Investigational Site Number 724008

    Manresa, 08243

  • Investigational Site Number 724009

    Oviedo, 33006

  • Investigational Site Number 724022

    Pamplona, 31008

  • Investigational Site Number 724005

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

  • Investigational Site Number 724016

    Santander, 39008

  • Investigational Site Number 724015

    Santiago de Compostela, 15706

  • Investigational Site Number 724024

    Seville, 41013

  • Investigational Site Number 724004

    Terrassa, 08221

  • Investigational Site Number 724013

    Valencia, 46009

  • Investigational Site Number 724014

    Valencia, 46015

  • Investigational Site Number 724001

    Zaragoza, 50009

Other trials in Spain

Australia22 sites

  • Investigational Site Number 036004

    Box Hill, 3128

  • Investigational Site Number 036020

    Campbelltown, 2560

  • Investigational Site Number 036001

    Camperdown, 2050

  • Investigational Site Number 036002

    Camperdown, 2050

  • Investigational Site Number 036011

    Douglas, 4814

  • Investigational Site Number 036019

    Nambour, 4560

  • Investigational Site Number 036023

    North Adelaide, 5006

  • Investigational Site Number 036008

    Parkville, 3050

  • Investigational Site Number 036005

    Perth

  • Investigational Site Number 036003

    Port Macquarie

  • Investigational Site Number 036025

    Randwick, 2031

  • Investigational Site Number 036009

    South Brisbane, 4101

  • Investigational Site Number 036022

    South Brisbane, 4101

  • Investigational Site Number 036017

    Southport, 4215

  • Investigational Site Number 036012

    St Leonards, 2065

  • Investigational Site Number 036010

    Sydney, 2076

  • Investigational Site Number 036013

    Sydney

  • Investigational Site Number 036014

    Sydney

  • Investigational Site Number 036016

    Tweed Heads

  • Investigational Site Number 036024

    Wendouree, 3355

  • Investigational Site Number 036007

    Westmead, 2145

  • Investigational Site Number 036015

    Wodonga

Other trials in Australia

United Kingdom12 sites

  • Investigational Site Number 826011

    Birmingham, B152TH

  • Investigational Site Number 826002

    Bristol, BS28ED

  • Investigational Site Number 826003

    Glasgow, G116NT

  • Investigational Site Number 826013

    Leeds, LS97TF

  • Investigational Site Number 826009

    London, SE19RT

  • Investigational Site Number 826012

    Manchester, M204BX

  • Investigational Site Number 826004

    Metropolitan Borough of Wirral, CH634JY

  • Investigational Site Number 826005

    Nottingham, NG51PB

  • Investigational Site Number 826008

    Preston, PR24QF

  • Investigational Site Number 826001

    Sutton, SM25PT

  • Investigational Site Number 826007

    Torquay, TQ27AA

  • Investigational Site Number 826006

    Whitechurch, CF142TL

Other trials in United Kingdom

Canada10 sites

  • Investigational Site Number 124012

    Kitchener, N2G1G3

  • Investigational Site Number 124009

    Laval, H7M3L9

  • Investigational Site Number 124004

    London, N6A 4L6

  • Investigational Site Number 124007

    Moncton, E1C6Z8

  • Investigational Site Number 124001

    Montreal, H2L 4M1

  • Investigational Site Number 124011

    Montreal, H3G1A4

  • Investigational Site Number 124010

    Québec, G1R 2J6

  • Investigational Site Number 124003

    Toronto, M4N3M5

  • Investigational Site Number 124002

    Toronto, M5G2M9

  • Investigational Site Number 124006

    Winnipeg, R3E0V9

Other trials in Canada

Belgium7 sites

  • Investigational Site Number 056002

    Bruges, 8000

  • Investigational Site Number 056007

    Brussels, 1020

  • Investigational Site Number 056003

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056005

    Liège, 4000

  • Investigational Site Number 056004

    Ottignies, 1340

  • Investigational Site Number 056001

    Roeselare, 8800

  • Investigational Site Number 056006

    Tournai, 7500

Other trials in Belgium

India5 sites

  • Investigational Site Number 356004

    Chennai, 600035

  • Investigational Site Number 356006

    Gūrgaon, 12201

  • Investigational Site Number 356001

    New Delhi, 110029

  • Investigational Site Number 356002

    New Delhi, 110085

  • Investigational Site Number 356005

    Trivandrum, 695011

Other trials in India

Portugal5 sites

  • Investigational Site Number 620002

    Coimbra, 3000-75

  • Investigational Site Number 620003

    Lisbon, 1099-023

  • Investigational Site Number 620004

    Lisbon, 1649-035

  • Investigational Site Number 620001

    Porto, 4200-072

  • Investigational Site Number 620005

    Setúbal, 2910-446

Other trials in Portugal

Taiwan5 sites

  • Investigational Site Number 005

    Kaohsiung Hsien,

  • Investigational Site Number 004

    Taichung, 407

  • Investigational Site Number 002

    Taipei, 100

  • Investigational Site Number 003

    Taipei

  • Investigational Site Number 001

    Tao Yuan Hsien

Other trials in Taiwan

Austria4 sites

  • Investigational Site Number 040-004

    Linz, 4010

  • Investigational Site Number 040-005

    Salzburg

  • Investigational Site Number 040-002

    Vienna, 1090

  • Investigational Site Number 040-003

    Vienna

Other trials in Austria

Bulgaria4 sites

  • Investigational Site Number 100004

    Plovdiv, 4000

  • Investigational Site Number 100001

    Sofia, 1527

  • Investigational Site Number 100003

    Sofia, 1756

  • Investigational Site Number 100002

    Sofia

Other trials in Bulgaria

Hungary4 sites

  • Investigational Site Number 348001

    Budapest, 1032

  • Investigational Site Number 348002

    Szolnok, 5000

  • Investigational Site Number 348003

    Szombathely, 9700

  • Investigational Site Number 348004

    Veszprém, 8200

Other trials in Hungary

Ireland4 sites

  • Investigational Site Number 372004

    Cork

  • Investigational Site Number 372001

    Dublin

  • Investigational Site Number 372002

    Dublin

  • Investigational Site Number 372003

    Dublin

Other trials in Ireland

Mexico4 sites

  • Investigational Site Number 484002

    Durango, 34000

  • Investigational Site Number 484006

    Irapuato, 36500

  • Investigational Site Number 484005

    Toluca, 50180

  • Investigational Site Number 484001

    Zapopan, 45200

Other trials in Mexico

Bosnia and Herzegovina3 sites

  • Investigational Site Number 070003

    Banja Luka

  • Investigational Site Number 070001

    Sarajevo

  • Investigational Site Number 070002

    Zenica

Other trials in Bosnia and Herzegovina

Denmark3 sites

  • Investigational Site Number 208-001

    Cph Ø, 2100

  • Investigational Site Number 208-002

    Herlev, 2730

  • Investigational Site Number 208-003

    Odense, 5000

Other trials in Denmark

Malaysia3 sites

  • Investigational Site Number 458002

    George Town, 10050

  • Investigational Site Number 458001

    Kuala Lumpur, 59100

  • Investigational Site Number 458003

    Kuching, 93586

Other trials in Malaysia

Romania3 sites

  • Investigational Site Number 642001

    Bucharest, 030171

  • Investigational Site Number 642002

    Cluj-Napoca, 400015

  • Investigational Site Number 642003

    Timișoara, 300239

Other trials in Romania

Finland2 sites

  • Investigational Site Number 246002

    Helsinki, 00180

  • Investigational Site Number 246001

    Seinäjoki, 60220

Other trials in Finland

Kazakhstan2 sites

  • Investigational Site Number 398001

    Almaty

  • Investigational Site Number 398003

    Shymkent

Other trials in Kazakhstan

Serbia2 sites

  • Investigational Site Number 688001

    Belgrade

  • Investigational Site Number 688002

    Belgrade

Other trials in Serbia

Singapore2 sites

  • Investigational Site Number 702002

    Singapore, 169610

  • Investigational Site Number 702001

    Singapore, 258499

Other trials in Singapore

Slovakia2 sites

  • Investigational Site Number 703001

    Bratislava, 83310

  • Investigational Site Number 703002

    Košice, 04190

Other trials in Slovakia

Sweden2 sites

  • Investigational Site Number 752-002

    Umeå, 90185

  • Investigational Site Number 752-001

    Uppsala, 75185

Other trials in Sweden

Croatia1 site

  • Investigational Site Number 191-001

    Zagreb, 10000

Other trials in Croatia

Czechia1 site

  • Investigational Site Number 203001

    Brno, 65653

Other trials in Czechia

Luxembourg1 site

  • Investigational Site Number 442001

    Niedercorn, 4602

Other trials in Luxembourg

Philippines1 site

  • Investigational Site Number 608001

    Manila, 1000

Other trials in Philippines

Poland1 site

  • Investigational Site Number 616-001

    Gdansk, 80-952

Other trials in Poland

About this study

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

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.

Being tested
CABAZITAXEL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABAZITAXELDrug

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

Study groups in NCT01254279
Study groupRoleWhat they receive
CabazitaxelExperimentalCabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisone or prednisolone 10 mg daily
Receives: Drug: CABAZITAXEL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen

    Measured: Up to 30 weeks

Secondary outcomes (1)

  1. To document safety of cabazitaxel in these patients

    Measured: Up to 35 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01254279
Sponsor's protocol ID
CABAZ_C_05331
Other IDs
2010-021128-92, U1111-1115-2476
Status last verified
Jan 2015
First submitted
2 Dec 2010
Last updated
21 Jan 2015
Results posted
No

Publications

  • 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.

    PubMed 25639506

  • 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.

    PubMed 25001524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CABAZITAXEL in people with Prostate Cancer Metastatic, run by Sanofi at 165 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in Italy, Spain, Australia, United Kingdom, Canada and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01254279, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in