This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: January 12, 2017
Last verified: December 2016
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 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 (OS) [ Time Frame: Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months) ]
    OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months) ]
    PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.

  • Time to Tumor Progression Free Survival [ Time Frame: Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months) ]
    Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.

  • Percentage of Participants With Overall Objective Tumor Response [ Time Frame: Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months) ]
    Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  • Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS) [ Time Frame: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier ((maximum duration: 51 months) ]
    Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.

  • Percentage of Participants With PSA Response [ Time Frame: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months) ]
    PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.

  • Time to Pain Progression Free Survival (Pain PFS) [ Time Frame: Baseline until disease progression, death or study cut-off date (maximum duration: 51 months) ]
    Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.

  • Percentage of Participants With Pain Response [ Time Frame: Baseline until pain progression, death or study cut-off date (maximum duration: 51 months) ]
    Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.

  • Skeletal Related Events (SRE) Free Survival [ Time Frame: Baseline until occurrence of first SRE or death (maximum duration: 51 months) ]
    SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.

  • Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL) [ Time Frame: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks) ]
    FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.

  • Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL [ Time Frame: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks) ]
    FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.


Enrollment: 1168
Study Start Date: May 2011
Estimated Study Completion Date: October 2017
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Cabazitaxel (XRP6258)
Pharmaceutical form: Solution for injection; Route of administration: Intravenous
Drug: Prednisone
Pharmaceutical form: Tablet; Route of administration: Oral
Experimental: 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.
Drug: Cabazitaxel (XRP6258)
Pharmaceutical form: Solution for injection; Route of administration: Intravenous
Drug: Prednisone
Pharmaceutical form: Tablet; Route of administration: Oral
Active Comparator: 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.
Drug: Docetaxel (XRP6976)
Pharmaceutical form: Solution for injection'; Route of administration: Intravenous
Drug: Prednisone
Pharmaceutical form: Tablet; Route of administration: Oral

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 come first.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.
  • 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 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, 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.

  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 840238
Boston, Massachusetts, United States, 02114
Investigational Site Number 840138
Boston, Massachusetts, United States, 02115
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 076001
Porto Alegre, Brazil, 90035-001
Investigational Site Number 076002
Porto Alegre, Brazil, 90610-000
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 156002
Shanghai, China, 200032
Investigational Site Number 156003
Shanghai, China, 200040
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 604006
Lima, Peru, 027
Investigational Site Number 604001
Lima, Peru, 041
Investigational Site Number 604005
Lima, Peru, LIMA 01
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 620005
Lisboa, Portugal, 1099-023
Investigational Site Number 620004
Lisboa, Portugal, 1649-035
Investigational Site Number 620001
Porto, Portugal, 4200
Investigational Site Number 620002
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 724001
Barcelona, Spain, 08003
Investigational Site Number 724007
Barcelona, Spain, 08025
Investigational Site Number 724002
Barcelona, Spain, 08036
Investigational Site Number 724003
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724005
Madrid, Spain, 28007
Investigational Site Number 724004
Madrid, Spain, 28041
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

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 ( EudraCT Number )
U1111-1117-8356 ( Other Identifier: UTN )
Study First Received: March 3, 2011
Results First Received: September 8, 2016
Last Updated: January 12, 2017

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
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 June 23, 2017