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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01308567
First received: March 3, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

Primary Objective:

  • To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients 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/m² and 25 mg/m² to docetaxel for:

    • Progression Free Survival (PFS) (RECIST 1.1)
    • Tumor progression free survival (RECIST 1.1)
    • Tumor response in patients with measurable disease (RECIST 1.1),
    • PSA response
    • PSA-Progression free survival (PSA-PFS).
    • Pain response in patients 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.

Condition Intervention Phase
Prostate Cancer
Drug: Cabazitaxel (XRP6258)
Drug: Docetaxel (XRP6976)
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • overall survival [ Time Frame: up to 57 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: up to 57 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1170
Study Start Date: May 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Cabazitaxel 25 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral

Experimental: Arm B
Cabazitaxel 20 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Drug: Cabazitaxel (XRP6258)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral

Active Comparator: Arm C
Docetaxel 75 mg/m² intravenously (Day 1) every 3 weeks. Prednisone 10 mg PO daily, from day 1 continuously
Drug: Docetaxel (XRP6976)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Prednisone

Pharmaceutical form:tablet

Route of administration: oral


Detailed Description:

Patients will be treated until progressive disease, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 .

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. Patients may be on biphosphonates prior to study entry.
  • E 03. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
  • E 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
  • 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, 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 patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
  • E 14. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.
  • E 15. Patients with reproductive potential who do 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308567

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840004
Muscle Shoals, Alabama, United States, 35661
United States, California
Investigational Site Number 840009
Anaheim, California, United States, 92801
Investigational Site Number 840014
Bakersfield, California, United States, 93309
Investigational Site Number 840030
Sacramento, California, United States, 95816
Investigational Site Number 840003
San Bernardino, California, United States, 92404
Investigational Site Number 840012
San Francisco, California, United States, 94143
United States, Colorado
Investigational Site Number 840019
Denver, Colorado, United States, 80262
United States, Florida
Investigational Site Number 840013
Boca Raton, Florida, United States, 33486
Investigational Site Number 840035
Jacksonville, Florida, United States, 32256
Investigational Site Number 840001
Port St. Lucie, Florida, United States, 34952
United States, Illinois
Investigational Site Number 840015
Decatur, Illinois, United States, 62526
United States, Kansas
Investigational Site Number 840018
Wichita, Kansas, United States, 67214
United States, Kentucky
Investigational Site Number 840010
Paducah, Kentucky, United States, 42002
United States, Louisiana
Investigational Site Number 840008
New Orleans, Louisiana, United States, 70112
United States, Maryland
Investigational Site Number 840006
Rockville, Maryland, United States, 20850
United States, Massachusetts
Investigational Site Number 840138
Boston, Massachusetts, United States, 02115
Investigational Site Number 840238
Boston, Massachusetts, United States, 02114
Investigational Site Number 840038
Brookline, Massachusetts, United States, 02115
United States, Michigan
Investigational Site Number 840005
Detroit, Michigan, United States, 48202
United States, Minnesota
Investigational Site Number 840021
St Louis Park, Minnesota, United States, 55416
United States, Missouri
Investigational Site Number 840016
Kansas City, Missouri, United States, 64128
United States, Nebraska
Investigational Site Number 840020
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Investigational Site Number 840017
East Orange, New Jersey, United States, 07018
United States, New Mexico
Investigational Site Number 840033
Albuquerque, New Mexico, United States, 87109
United States, North Carolina
Investigational Site Number 840036
Raleigh, North Carolina, United States, 27607
Investigational Site Number 840011
Washington, North Carolina, United States, 27889
United States, Ohio
Investigational Site Number 840026
Akron, Ohio, United States, 44302
Investigational Site Number 840023
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Investigational Site Number 840032
Dunmore, Pennsylvania, United States, 18512
United States, Rhode Island
Investigational Site Number 840007
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Investigational Site Number 840037
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Investigational Site Number 840028
Chattanooga, Tennessee, United States, 37421
Australia
Investigational Site Number 036016
Bankstown, Australia, 2200
Investigational Site Number 036008
Camperdown, Australia, 2050
Investigational Site Number 036015
Coffs Harbour, Australia, 2450
Investigational Site Number 036001
Concord, Australia, 2137
Investigational Site Number 036017
Fitzroy, Australia, 3065
Investigational Site Number 036003
Herston, Australia, 4029
Investigational Site Number 036010
Hornsby, Australia, 2077
Investigational Site Number 036012
Kurralta Park, Australia, 5037
Investigational Site Number 036002
Parkville, Australia, 3050
Investigational Site Number 036009
South Brisbane, Australia, 4101
Investigational Site Number 036011
Subiaco, Australia, 6008
Investigational Site Number 036013
Wodonga, Australia, 3690
Belarus
Investigational Site Number 112001
Minsk, Belarus, 220013
Investigational Site Number 112002
Minsk, Belarus, 223040
Investigational Site Number 112004
Vitebsk, Belarus, 210603
Brazil
Investigational Site Number 076006
Passo Fundo, Brazil, 99010-260
Investigational Site Number 076002
Porto Alegre, Brazil, 90610-000
Investigational Site Number 076001
Porto Alegre, Brazil, 90035-001
Investigational Site Number 076004
Rio De Janeiro, Brazil, 20230-130
Investigational Site Number 076009
Sao Jose Do Rio Preto, Brazil, 15090-000
Investigational Site Number 076005
Sao Paulo, Brazil, 01246-000
Investigational Site Number 076003
Uberlandia, Brazil, 38408 150
Canada
Investigational Site Number 124002
London, Canada, N6A 4L6
Investigational Site Number 124007
Mississauga, Canada, L5M 2N1
Investigational Site Number 124005
Moncton, Canada, E1C 6Z8
Investigational Site Number 124003
Montreal, Canada, H2L 4M1
Investigational Site Number 124004
Quebec, Canada, G1R 2J6
Investigational Site Number 124006
Toronto, Canada, M4N 3M5
China
Investigational Site Number 156005
Beijing, China, 100034
Investigational Site Number 156003
Shanghai, China, 200040
Investigational Site Number 156002
Shanghai, China, 200032
Investigational Site Number 156004
Shanghai, China, 200040
Czech Republic
Investigational Site Number 203002
Brno, Czech Republic, 65653
Investigational Site Number 203003
Novy Jicin, Czech Republic, 74101
Investigational Site Number 203001
Olomouc, Czech Republic, 77520
Investigational Site Number 203004
Praha 2, Czech Republic, 12808
Denmark
Investigational Site Number 208002
Herlev, Denmark, 2730
Investigational Site Number 208001
København Ø, Denmark, 2100
Investigational Site Number 208003
Odense C, Denmark, 5000
Investigational Site Number 208004
Ålborg, Denmark, 9100
Finland
Investigational Site Number 246002
Helsinki, Finland, 00290
Investigational Site Number 246001
Kuopio, Finland, 70210
Investigational Site Number 246003
Turku, Finland, FIN-20520
France
Investigational Site Number 250010
Besancon Cedex, France, 25030
Investigational Site Number 250002
Bordeaux Cedex, France, 33076
Investigational Site Number 250006
Caen Cedex 05, France, 14076
Investigational Site Number 250005
Lyon, France, 69373
Investigational Site Number 250003
Paris Cedex 05, France, 75231
Investigational Site Number 250004
Paris Cedex 10, France, 75475
Investigational Site Number 250001
Paris Cedex 15, France, 75908
Investigational Site Number 250007
Poitiers Cedex, France, 86021
Investigational Site Number 250008
Suresnes, France, 92151
Investigational Site Number 250009
Villejuif, France, 94805
Germany
Investigational Site Number 276003
Aachen, Germany, 52074
Investigational Site Number 276005
Berlin, Germany, 14197
Investigational Site Number 276001
Düsseldorf, Germany, 40225
Investigational Site Number 276004
Erlangen, Germany, 91054
Investigational Site Number 276002
Homburg, Germany, 66421
Investigational Site Number 276006
München, Germany, 81675
Israel
Investigational Site Number 376004
Kfar Saba, Israel, 44281
Investigational Site Number 376003
Petah-Tikva, Israel, 49100
Investigational Site Number 376002
Tel Aviv, Israel, 64239
Italy
Investigational Site Number 380001
Arezzo, Italy, 06156
Investigational Site Number 380004
Bari, Italy, 70124
Investigational Site Number 380003
Orbassano, Italy, 10043
Investigational Site Number 380005
Roma, Italy, 00144
Investigational Site Number 380002
Trento, Italy, 38100
Japan
Investigational Site Number 392001
Bunkyo-Ku, Japan
Investigational Site Number 392003
Chiba-Shi, Japan
Investigational Site Number 392006
Kashiwa-Shi, Japan
Investigational Site Number 392005
Koto-Ku, Japan
Investigational Site Number 392002
Osaka Sayama-Shi, Japan
Investigational Site Number 392004
Osaka-Shi, Japan
Mexico
Investigational Site Number 484007
Acapulco, Mexico, 39670
Investigational Site Number 484008
Aguascalientes, Mexico, 20230
Investigational Site Number 484003
D.f., Mexico, 14080
Investigational Site Number 484004
Guadalajara, Mexico, 44280
Investigational Site Number 484009
Merida, Mexico, 97134
Investigational Site Number 484005
Queretaro, Mexico, 76000
Investigational Site Number 484002
San Luis Potosi, Mexico
Investigational Site Number 484006
Zapopan, Mexico, 45040
Peru
Investigational Site Number 604005
Lima, Peru, LIMA 01
Investigational Site Number 604001
Lima, Peru, 041
Investigational Site Number 604006
Lima, Peru, 027
Investigational Site Number 604002
Lima, Peru, LIMA 34
Poland
Investigational Site Number 616002
Bydgoszcz, Poland, 85-796
Investigational Site Number 616001
Gdansk, Poland, 80-952
Investigational Site Number 616003
Koscierzyna, Poland, 83-400
Investigational Site Number 616005
Lodz, Poland, 93-509
Investigational Site Number 616004
Poznan, Poland, 61-485
Portugal
Investigational Site Number 620003
Coimbra, Portugal, 3049
Investigational Site Number 620004
Lisboa, Portugal, 1649-035
Investigational Site Number 620005
Lisboa, Portugal, 1099-023
Investigational Site Number 620002
Porto, Portugal, 4200
Investigational Site Number 620001
Porto, Portugal, 4200
Romania
Investigational Site Number 642004
Baia Mare, Romania, 430031
Investigational Site Number 642008
Bucharest, Romania, 022328
Investigational Site Number 642005
Bucuresti, Romania, 022328
Investigational Site Number 642002
Cluj Napoca, Romania, 400015
Investigational Site Number 642003
Cluj Napoca, Romania, 400015
Investigational Site Number 642007
Hunedoara, Romania, 331057
Russian Federation
Investigational Site Number 643004
Ekaterinburg, Russian Federation, 620102
Investigational Site Number 643008
Moscow, Russian Federation, 129128
Investigational Site Number 643003
Omsk, Russian Federation, 644013
Investigational Site Number 643002
Pyatigorsk, Russian Federation, 357502
Investigational Site Number 643007
Ryazan, Russian Federation, 390011
Investigational Site Number 643005
St-Petersburg, Russian Federation, 197758
Investigational Site Number 643001
Tomsk, Russian Federation, 634028
Investigational Site Number 643006
Yaroslavl, Russian Federation, 150054
Spain
Investigational Site Number 724007
Barcelona, Spain, 08025
Investigational Site Number 724001
Barcelona, Spain, 08003
Investigational Site Number 724002
Barcelona, Spain, 08036
Investigational Site Number 724003
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724004
Madrid, Spain, 28041
Investigational Site Number 724005
Madrid, Spain, 28007
Investigational Site Number 724006
Santiago De Compostela, Spain, 15706
Sweden
Investigational Site Number 752003
Malmö, Sweden, 205 02
Investigational Site Number 752002
Stockholm, Sweden, 171 76
Investigational Site Number 752001
Uppsala, Sweden, 751 85
Taiwan
Investigational Site Number 158004
Kaohsiung, Taiwan, 833
Investigational Site Number 158002
Taichung, Taiwan, 407
Investigational Site Number 158001
Taipei, Taiwan
Investigational Site Number 158003
Tao-Yuan, Taiwan, 333
Turkey
Investigational Site Number 792002
Ankara, Turkey, 06100
Investigational Site Number 792001
Istanbul, Turkey, 34303
Ukraine
Investigational Site Number 804009
Cherkasy, Ukraine, 18009
Investigational Site Number 804004
Dnipropetrovsk, Ukraine, 49102
Investigational Site Number 804010
Donetsk, Ukraine, 83092
Investigational Site Number 804006
Ivano-Frankivsk, Ukraine, 76018
Investigational Site Number 804003
Kharkov, Ukraine, 61037
Investigational Site Number 804002
Kyiv, Ukraine, 01133
Investigational Site Number 804001
Kyiv, Ukraine, 1601
Investigational Site Number 804007
Lutsk, Ukraine, 43018
Investigational Site Number 804005
Uzhgorod, Ukraine, 88000
Investigational Site Number 804008
Zaporizhzhya, Ukraine, 69040
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01308567     History of Changes
Other Study ID Numbers: EFC11784, 2010-022064-12, U1111-1117-8356
Study First Received: March 3, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014