Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

NCT ID: NCT01308580

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-08-31

Brief Summary

Primary Objective:

• To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

• To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².
• To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

• Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;
• PSA Progression;
• Pain progression;
• Tumor response in participants with measurable disease (RECIST 1.1);
• PSA response;
• Pain response in participants with stable pain at baseline.
• To compare Health-related Quality of Life (HRQoL).
• To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

Detailed Description

Participants were treated until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever came first.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Group Type: EXPERIMENTAL

Cabazitaxel (XRP6258)

Intervention Type: DRUG

Pharmaceutical form: Concentrate and solvent for solution for infusion

Route of administration: Intravenous

Prednisone (or Prednisolone)

Intervention Type: DRUG

Pharmaceutical form: Tablet

Route of administration: Oral

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Group Type: EXPERIMENTAL

Cabazitaxel (XRP6258)

Intervention Type: DRUG

Pharmaceutical form: Concentrate and solvent for solution for infusion

Route of administration: Intravenous

Prednisone (or Prednisolone)

Intervention Type: DRUG

Pharmaceutical form: Tablet

Route of administration: Oral

Interventions

Cabazitaxel (XRP6258)

Pharmaceutical form: Concentrate and solvent for solution for infusion

Route of administration: Intravenous

Intervention Type: DRUG

Prednisone (or Prednisolone)

Pharmaceutical form: Tablet

Route of administration: Oral

Intervention Type: DRUG

Other Intervention Names

Jevtana®

Eligibility Criteria

Inclusion Criteria

I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was resistant to hormone therapy and previously treated with a docetaxel-containing regimen.

I 02. Participant must had either measurable or non-measurable disease. I 03. Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents.

I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours).

I 06. Age ≥18 years (or country's legal age of majority if the legal age was > 18 years).

Exclusion Criteria

E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must had elapsed prior to first study drug administration.

E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study.

E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 5 years ago and from which the participant had been disease-free for ≥ 5 years.

E 06. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.

E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months was also not allowed.

E 10. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or to comply with the study procedures or interfere with interpretation of study results.

E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.

E 12. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" was based on the Investigator's judgment. Participant's Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason had no chance of becoming pregnant) not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and /or in a local protocol addendum.

E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E 16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840002

Muscle Shoals, Alabama, United States

Investigational Site Number 840004

Hot Springs, Arkansas, United States

Investigational Site Number 840008

Anaheim, California, United States

Investigational Site Number 840010

La Jolla, California, United States

Investigational Site Number 840001

San Bernardino, California, United States

Investigational Site Number 840021

Stamford, Connecticut, United States

Investigational Site Number 840023

Jacksonville, Florida, United States

Investigational Site Number 840013

Lakeland, Florida, United States

Investigational Site Number 840003

Port Saint Lucie, Florida, United States

Investigational Site Number 840007

New Orleans, Louisiana, United States

Investigational Site Number 840014

Baltimore, Maryland, United States

Investigational Site Number 840005

Rockville, Maryland, United States

Investigational Site Number 840017

Saint Louis Park, Minnesota, United States

Investigational Site Number 840011

Jackson, Mississippi, United States

Investigational Site Number 840016

Lincoln, Nebraska, United States

Investigational Site Number 840015

East Orange, New Jersey, United States

Investigational Site Number 840024

Raleigh, North Carolina, United States

Investigational Site Number 840020

Akron, Ohio, United States

Investigational Site Number 840006

Pawtucket, Rhode Island, United States

Investigational Site Number 840025

Chattanooga, Tennessee, United States

Investigational Site Number 840012

Corpus Christi, Texas, United States

Investigational Site Number 032002

Buenos Aires, , Argentina

Investigational Site Number 032001

Rosario, , Argentina

Investigational Site Number 032003

Salta, , Argentina

Investigational Site Number 032004

Santa Fe, , Argentina

Investigational Site Number 036014

Adelaide, , Australia

Investigational Site Number 036013

Bankstown, , Australia

Investigational Site Number 036010

Box Hill, , Australia

Investigational Site Number 036012

Camperdown, , Australia

Investigational Site Number 036008

Coffs Harbour, , Australia

Investigational Site Number 036001

Concord, , Australia

Investigational Site Number 036015

Elizabeth Vale, , Australia

Investigational Site Number 036009

Fitzroy, , Australia

Investigational Site Number 036007

Garran, , Australia

Investigational Site Number 036005

Heidelberg West, , Australia

Investigational Site Number 036002

Malvern, , Australia

Investigational Site Number 036006

South Brisbane, , Australia

Investigational Site Number 036016

Subiaco, , Australia

Investigational Site Number 036003

Wahroonga, , Australia

Investigational Site Number 036004

Wodonga, , Australia

Investigational Site Number 056007

Antwerp, , Belgium

Investigational Site Number 056001

Brussels, , Belgium

Investigational Site Number 056008

Brussels, , Belgium

Investigational Site Number 056002

Brussels, , Belgium

Investigational Site Number 056009

Charleroi, , Belgium

Investigational Site Number 056003

Ghent, , Belgium

Investigational Site Number 056012

Godinne, , Belgium

Investigational Site Number 056016

Haine-Saint-Paul, , Belgium

Investigational Site Number 056005

Hasselt, , Belgium

Investigational Site Number 056010

Libramont, , Belgium

Investigational Site Number 056013

Liège, , Belgium

Investigational Site Number 056011

Ottignies, , Belgium

Investigational Site Number 056004

Roeselare, , Belgium

Investigational Site Number 056006

Turnhout, , Belgium

Investigational Site Number 076016

Fortaleza, , Brazil

Investigational Site Number 076012

Ijuí, , Brazil

Investigational Site Number 076015

Mogi das Cruzes, , Brazil

Investigational Site Number 076014

Porto Alegre, , Brazil

Investigational Site Number 076010

Rio de Janeiro, , Brazil

Investigational Site Number 076007

Salvador, , Brazil

Investigational Site Number 076003

São José do Rio Preto, , Brazil

Investigational Site Number 076009

São Paulo, , Brazil

Investigational Site Number 076001

São Paulo, , Brazil

Investigational Site Number 076013

São Paulo, , Brazil

Investigational Site Number 076008

São Paulo, , Brazil

Investigational Site Number 076002

São Paulo, , Brazil

Investigational Site Number 124002

Greenfield Park, , Canada

Investigational Site Number 124001

Oshawa, , Canada

Investigational Site Number 124003

Ottawa, , Canada

Investigational Site Number 124005

Owen Sound, , Canada

Investigational Site Number 152005

Santiago, , Chile

Investigational Site Number 152004

Santiago, , Chile

Investigational Site Number 152002

Santiago, , Chile

Investigational Site Number 152001

Viña del Mar, , Chile

Investigational Site Number 250005

Avignon, , France

Investigational Site Number 250008

Hyères, , France

Investigational Site Number 250001

La Roche-sur-Yon, , France

Investigational Site Number 250002

Nantes, , France

Investigational Site Number 250004

Nîmes, , France

Investigational Site Number 250010

Paris, , France

Investigational Site Number 250009

Reims, , France

Investigational Site Number 250007

Reims, , France

Investigational Site Number 250006

Saint-Brieuc, , France

Investigational Site Number 250003

Toulouse, , France

Investigational Site Number 250011

Toulouse, , France

Investigational Site Number 276003

Aachen, , Germany

Investigational Site Number 276007

Dresden, , Germany

Investigational Site Number 276004

Düsseldorf, , Germany

Investigational Site Number 276001

Erlangen, , Germany

Investigational Site Number 276011

Hamburg, , Germany

Investigational Site Number 276005

Hamburg, , Germany

Investigational Site Number 276010

Homburg, , Germany

Investigational Site Number 276006

München, , Germany

Investigational Site Number 276012

Nürtingen, , Germany

Investigational Site Number 276008

Tübingen, , Germany

Investigational Site Number 276002

Wuppertal, , Germany

Investigational Site Number 348001

Budapest, , Hungary

Investigational Site Number 348005

Budapest, , Hungary

Investigational Site Number 348004

Budapest, , Hungary

Investigational Site Number 348006

Miskolc, , Hungary

Investigational Site Number 348003

Pécs, , Hungary

Investigational Site Number 528005

Arnhem, , Netherlands

Investigational Site Number 528003

Blaricum, , Netherlands

Investigational Site Number 528004

Hoofddorp, , Netherlands

Investigational Site Number 528002

Nijmegen, , Netherlands

Investigational Site Number 528001

Zwolle, , Netherlands

Investigational Site Number 604003

Arequipa, , Peru

Investigational Site Number 604006

Lima, , Peru

Investigational Site Number 604001

Lima, , Peru

Investigational Site Number 604007

Lima, , Peru

Investigational Site Number 604002

Lima, , Peru

Investigational Site Number 604004

Lima, , Peru

Investigational Site Number 604005

Lima, , Peru

Investigational Site Number 616006

Lubin, , Poland

Investigational Site Number 616002

Olsztyn, , Poland

Investigational Site Number 616001

Rybnik, , Poland

Investigational Site Number 616005

Siedlce, , Poland

Investigational Site Number 616004

Torun, , Poland

Investigational Site Number 642005

Alba Iulia, , Romania

Investigational Site Number 642006

Baia Mare, , Romania

Investigational Site Number 642009

Bucharest, , Romania

Investigational Site Number 642008

Bucharest, , Romania

Investigational Site Number 642001

Cluj-Napoca, , Romania

Investigational Site Number 642003

Cluj-Napoca, , Romania

Investigational Site Number 642004

Cluj-Napoca, , Romania

Investigational Site Number 642002

Cluj-Napoca, , Romania

Investigational Site Number 642012

Focşani, , Romania

Investigational Site Number 642007

Hunedoara, , Romania

Investigational Site Number 642013

Onești, , Romania

Investigational Site Number 643007

Moscow, , Russia

Investigational Site Number 643005

Moscow, , Russia

Investigational Site Number 643004

Moscow, , Russia

Investigational Site Number 643006

Moscow, , Russia

Investigational Site Number 643008

Obninsk, , Russia

Investigational Site Number 643001

Saint Petersburg, , Russia

Investigational Site Number 643010

Saint Petersburg, , Russia

Investigational Site Number 643003

Tula, , Russia

Investigational Site Number 643009

Yekaterinburg, , Russia

Investigational Site Number 710003

Cape Town, , South Africa

Investigational Site Number 710002

Durban, , South Africa

Investigational Site Number 710005

Johannesburg, , South Africa

Investigational Site Number 710004

Johannesburg, , South Africa

Investigational Site Number 710001

Pretoria, , South Africa

Investigational Site Number 410003

Seongnam, , South Korea

Investigational Site Number 410002

Seoul, , South Korea

Investigational Site Number 410004

Seoul, , South Korea

Investigational Site Number 410005

Seoul, , South Korea

Investigational Site Number 410001

Seoul, , South Korea

Investigational Site Number 724003

Badalona, , Spain

Investigational Site Number 724001

Barcelona, , Spain

Investigational Site Number 724002

Madrid, , Spain

Investigational Site Number 724008

Madrid, , Spain

Investigational Site Number 724006

Málaga, , Spain

Investigational Site Number 724005

Palma de Mallorca, , Spain

Investigational Site Number 724004

Sabadell, , Spain

Investigational Site Number 724007

Seville, , Spain

Investigational Site Number 158002

Taiching, , Taiwan

Investigational Site Number 158003

Tainan City, , Taiwan

Investigational Site Number 158001

Taipei, , Taiwan

Investigational Site Number 788004

Sfax, , Tunisia

Investigational Site Number 788003

Sousse, , Tunisia

Investigational Site Number 788002

Tunis, , Tunisia

Investigational Site Number 792003

Antalya, , Turkey (Türkiye)

Investigational Site Number 792001

Bornova, , Turkey (Türkiye)

Investigational Site Number 792002

Istanbul, , Turkey (Türkiye)

Investigational Site Number 826002

Birmingham, , United Kingdom

Investigational Site Number 826004

Colchester, , United Kingdom

Investigational Site Number 826005

Glasgow, , United Kingdom

Investigational Site Number 826006

Guildford, , United Kingdom

Investigational Site Number 826007

Manchester, , United Kingdom

Investigational Site Number 826003

Newcastle upon Tyne, , United Kingdom

Investigational Site Number 826001

Sutton, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; France; Germany; Hungary; Netherlands; Peru; Poland; Romania; Russia; South Africa; South Korea; Spain; Taiwan; Tunisia; Turkey (Türkiye); United Kingdom

References

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Other Identifiers

2010-022163-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC11785

Identifier Type: -

Identifier Source: org_study_id