Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

NCT ID: NCT01308567

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-05
• Study Completion Date: 2018-05-31

Brief Summary

Primary Objective:

• To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

• To evaluate safety in the 3 treatment arms.
• To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:

• Progression Free Survival (PFS) (RECIST 1.1)
• Tumor progression free survival (RECIST 1.1)
• Tumor response in participants with measurable disease (RECIST 1.1),
• PSA response
• PSA-Progression free survival (PSA-PFS).
• Pain response in participants with stable pain at baseline
• Pain progression free survival
• Time to occurrence of any skeletal related events (SRE)
• To compare Health-Related Quality of Life (HRQL).
• To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Detailed Description

Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. 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 comes first.

Conditions

Prostate Cancer

Study Design

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

Study Groups

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.

Group Type: EXPERIMENTAL

Cabazitaxel (XRP6258)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Prednisone

Intervention Type: DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Group Type: EXPERIMENTAL

Cabazitaxel (XRP6258)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Prednisone

Intervention Type: DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Docetaxel 75 mg/m^2

Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Group Type: ACTIVE_COMPARATOR

Docetaxel (XRP6976)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection'; Route of administration: Intravenous

Prednisone

Intervention Type: DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Interventions

Cabazitaxel (XRP6258)

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Intervention Type: DRUG

Docetaxel (XRP6976)

Pharmaceutical form: Solution for injection'; Route of administration: Intravenous

Intervention Type: DRUG

Prednisone

Pharmaceutical form: Tablet; Route of administration: Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• I 01. Histologically- or cytologically-confirmed prostate adenocarcinoma.
• I 02. Metastatic disease.
• I 03. Progressive disease while receiving hormonal therapy or after surgical castration.
• I 04. Effective castration (serum testosterone levels ≤0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone (LHRH) agonists or antagonist with or without anti-androgens.

Exclusion Criteria

• E 01. Prior chemotherapy for prostate cancer,
• E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry.
• E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
• E 05. Less than 18 years (or country's legal age of majority if the legal age is >18 years).
• E 06. Eastern Cooperative Oncology Group (ECOG) performance status >2.
• E 07. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
• E 08. Prior malignancy.
• E 09. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
• E 10. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack.
• E 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
• E 12. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
• E 13. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures.
• E 14. Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study.
• E 15. Participants with reproductive potential who did not agree to use accepted and effective method of contraception during the study treatment period.
• E 16. History of hypersensitivity to docetaxel, or polysorbate 80.
• E 17. Inadequate organ and bone marrow function
• E 18. Contraindications to the use of corticosteroid treatment.
• E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [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 840004

Muscle Shoals, Alabama, United States

Investigational Site Number 840009

Anaheim, California, United States

Investigational Site Number 840014

Bakersfield, California, United States

Investigational Site Number 840030

Sacramento, California, United States

Investigational Site Number 840003

San Bernardino, California, United States

Investigational Site Number 840012

San Francisco, California, United States

Investigational Site Number 840019

Denver, Colorado, United States

Investigational Site Number 840013

Boca Raton, Florida, United States

Investigational Site Number 840035

Jacksonville, Florida, United States

Investigational Site Number 840001

Port Saint Lucie, Florida, United States

Investigational Site Number 840015

Decatur, Illinois, United States

Investigational Site Number 840018

Wichita, Kansas, United States

Investigational Site Number 840010

Paducah, Kentucky, United States

Investigational Site Number 840008

New Orleans, Louisiana, United States

Investigational Site Number 840006

Rockville, Maryland, United States

Investigational Site Number 840238

Boston, Massachusetts, United States

Investigational Site Number 840138

Boston, Massachusetts, United States

Investigational Site Number 840038

Brookline, Massachusetts, United States

Investigational Site Number 840005

Detroit, Michigan, United States

Investigational Site Number 840021

Saint Louis Park, Minnesota, United States

Investigational Site Number 840016

Kansas City, Missouri, United States

Investigational Site Number 840020

Lincoln, Nebraska, United States

Investigational Site Number 840017

East Orange, New Jersey, United States

Investigational Site Number 840033

Albuquerque, New Mexico, United States

Investigational Site Number 840036

Raleigh, North Carolina, United States

Investigational Site Number 840011

Washington, North Carolina, United States

Investigational Site Number 840026

Akron, Ohio, United States

Investigational Site Number 840023

Cleveland, Ohio, United States

Investigational Site Number 840032

Dunmore, Pennsylvania, United States

Investigational Site Number 840007

Pawtucket, Rhode Island, United States

Investigational Site Number 840037

Myrtle Beach, South Carolina, United States

Investigational Site Number 840028

Chattanooga, Tennessee, United States

Investigational Site Number 036016

Bankstown, , Australia

Investigational Site Number 036008

Camperdown, , Australia

Investigational Site Number 036015

Coffs Harbour, , Australia

Investigational Site Number 036001

Concord, , Australia

Investigational Site Number 036017

Fitzroy, , Australia

Investigational Site Number 036003

Herston, , Australia

Investigational Site Number 036010

Hornsby, , Australia

Investigational Site Number 036012

Kurralta Park, , Australia

Investigational Site Number 036002

Parkville, , Australia

Investigational Site Number 036009

South Brisbane, , Australia

Investigational Site Number 036011

Subiaco, , Australia

Investigational Site Number 036013

Wodonga, , Australia

Investigational Site Number 112001

Minsk, , Belarus

Investigational Site Number 112002

Minsk, , Belarus

Investigational Site Number 112004

Vitebsk, , Belarus

Investigational Site Number 076006

Passo Fundo, , Brazil

Investigational Site Number 076001

Porto Alegre, , Brazil

Investigational Site Number 076002

Porto Alegre, , Brazil

Investigational Site Number 076004

Rio de Janeiro, , Brazil

Investigational Site Number 076009

São José do Rio Preto, , Brazil

Investigational Site Number 076005

São Paulo, , Brazil

Investigational Site Number 076003

Uberlândia, , Brazil

Investigational Site Number 124002

London, , Canada

Investigational Site Number 124007

Mississauga, , Canada

Investigational Site Number 124005

Moncton, , Canada

Investigational Site Number 124003

Montreal, , Canada

Investigational Site Number 124004

Québec, , Canada

Investigational Site Number 124006

Toronto, , Canada

Investigational Site Number 156005

Beijing, , China

Investigational Site Number 156002

Shanghai, , China

Investigational Site Number 156003

Shanghai, , China

Investigational Site Number 156004

Shanghai, , China

Investigational Site Number 203002

Brno, , Czechia

Investigational Site Number 203003

Nový Jičín, , Czechia

Investigational Site Number 203001

Olomouc, , Czechia

Investigational Site Number 203004

Prague, , Czechia

Investigational Site Number 208004

Aalborg, , Denmark

Investigational Site Number 208002

Herlev, , Denmark

Investigational Site Number 208001

København Ø, , Denmark

Investigational Site Number 208003

Odense C, , Denmark

Investigational Site Number 246002

Helsinki, , Finland

Investigational Site Number 246001

Kuopio, , Finland

Investigational Site Number 246003

Turku, , Finland

Investigational Site Number 250010

Besançon, , France

Investigational Site Number 250002

Bordeaux, , France

Investigational Site Number 250006

Caen, , France

Investigational Site Number 250005

Lyon, , France

Investigational Site Number 250003

Paris, , France

Investigational Site Number 250004

Paris, , France

Investigational Site Number 250001

Paris, , France

Investigational Site Number 250007

Poitiers, , France

Investigational Site Number 250008

Suresnes, , France

Investigational Site Number 250009

Villejuif, , France

Investigational Site Number 276003

Aachen, , Germany

Investigational Site Number 276005

Berlin, , Germany

Investigational Site Number 276001

Düsseldorf, , Germany

Investigational Site Number 276004

Erlangen, , Germany

Investigational Site Number 276002

Homburg, , Germany

Investigational Site Number 276006

München, , Germany

Investigational Site Number 376004

Kfar Saba, , Israel

Investigational Site Number 376003

Petah Tikva, , Israel

Investigational Site Number 376002

Tel Aviv, , Israel

Investigational Site Number 380001

Arezzo, , Italy

Investigational Site Number 380004

Bari, , Italy

Investigational Site Number 380003

Orbassano, , Italy

Investigational Site Number 380005

Roma, , Italy

Investigational Site Number 380002

Trento, , Italy

Investigational Site Number 392001

Bunkyō City, , Japan

Investigational Site Number 392003

Chiba, , Japan

Investigational Site Number 392006

Kashiwa-Shi, , Japan

Investigational Site Number 392005

Kōtoku, , Japan

Investigational Site Number 392004

Osaka, , Japan

Investigational Site Number 392002

Osaka Sayama-Shi, , Japan

Investigational Site Number 484007

Acapulco, , Mexico

Investigational Site Number 484008

Aguascalientes, , Mexico

Investigational Site Number 484003

D.F., , Mexico

Investigational Site Number 484004

Guadalajara, , Mexico

Investigational Site Number 484009

Mérida, , Mexico

Investigational Site Number 484005

Querétaro, , Mexico

Investigational Site Number 484002

San Luis Potosí City, , Mexico

Investigational Site Number 484006

Zapopan, , Mexico

Investigational Site Number 604006

Lima, , Peru

Investigational Site Number 604001

Lima, , Peru

Investigational Site Number 604005

Lima, , Peru

Investigational Site Number 604002

Lima, , Peru

Investigational Site Number 616002

Bydgoszcz, , Poland

Investigational Site Number 616001

Gdansk, , Poland

Investigational Site Number 616003

Kościerzyna, , Poland

Investigational Site Number 616005

Lodz, , Poland

Investigational Site Number 616004

Poznan, , Poland

Investigational Site Number 620003

Coimbra, , Portugal

Investigational Site Number 620005

Lisbon, , Portugal

Investigational Site Number 620004

Lisbon, , Portugal

Investigational Site Number 620001

Porto, , Portugal

Investigational Site Number 620002

Porto, , Portugal

Investigational Site Number 642004

Baia Mare, , Romania

Investigational Site Number 642005

Bucharest, , Romania

Investigational Site Number 642008

Bucharest, , Romania

Investigational Site Number 642002

Cluj-Napoca, , Romania

Investigational Site Number 642003

Cluj-Napoca, , Romania

Investigational Site Number 642007

Hunedoara, , Romania

Investigational Site Number 643008

Moscow, , Russia

Investigational Site Number 643003

Omsk, , Russia

Investigational Site Number 643002

Pyatigorsk, , Russia

Investigational Site Number 643007

Ryazan, , Russia

Investigational Site Number 643005

Saint Petersburg, , Russia

Investigational Site Number 643001

Tomsk, , Russia

Investigational Site Number 643006

Yaroslavl, , Russia

Investigational Site Number 643004

Yekaterinburg, , Russia

Investigational Site Number 724001

Barcelona, , Spain

Investigational Site Number 724007

Barcelona, , Spain

Investigational Site Number 724002

Barcelona, , Spain

Investigational Site Number 724003

L'Hospitalet de Llobregat, , Spain

Investigational Site Number 724005

Madrid, , Spain

Investigational Site Number 724004

Madrid, , Spain

Investigational Site Number 724006

Santiago de Compostela, , Spain

Investigational Site Number 752003

Malmo, , Sweden

Investigational Site Number 752002

Stockholm, , Sweden

Investigational Site Number 752001

Uppsala, , Sweden

Investigational Site Number 158004

Kaohsiung City, , Taiwan

Investigational Site Number 158002

Taichung, , Taiwan

Investigational Site Number 158001

Taipei, , Taiwan

Investigational Site Number 158003

Taoyuan District, , Taiwan

Investigational Site Number 792002

Ankara, , Turkey (Türkiye)

Investigational Site Number 792001

Istanbul, , Turkey (Türkiye)

Investigational Site Number 804009

Cherkasy, , Ukraine

Investigational Site Number 804004

Dnipropetrovsk, , Ukraine

Investigational Site Number 804010

Donetsk, , Ukraine

Investigational Site Number 804006

Ivano-Frankivsk, , Ukraine

Investigational Site Number 804003

Kharkiv, , Ukraine

Investigational Site Number 804002

Kyiv, , Ukraine

Investigational Site Number 804001

Kyiv, , Ukraine

Investigational Site Number 804007

Lutsk, , Ukraine

Investigational Site Number 804005

Uzhhorod, , Ukraine

Investigational Site Number 804008

Zaporizhzhya, , Ukraine

Countries

United States; Australia; Belarus; Brazil; Canada; China; Czechia; Denmark; Finland; France; Germany; Israel; Italy; Japan; Mexico; Peru; Poland; Portugal; Romania; Russia; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine

References

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Other Identifiers

2010-022064-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1117-8356

Identifier Type: OTHER

Identifier Source: secondary_id

EFC11784

Identifier Type: -

Identifier Source: org_study_id