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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01308580




Trial ID
NCT01308580
Ethics application status
Date submitted
3/03/2011
Date registered
3/03/2011
Date last updated
16/03/2017

Titles & IDs
Public title
Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer
Scientific title
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen
Secondary ID [1] 0 0
2010-022163-35
Secondary ID [2] 0 0
EFC11785
Universal Trial Number (UTN)
Trial acronym
PROSELICA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cabazitaxel (XRP6258)
Treatment: Drugs - Prednisone (or Prednisolone)

Experimental: 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.

Experimental: 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.


Treatment: Drugs: Cabazitaxel (XRP6258)
Pharmaceutical form: Concentrate and solvent for solution for infusion
Route of administration: Intravenous

Treatment: Drugs: Prednisone (or Prednisolone)
Pharmaceutical form: Tablet
Route of administration: Oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.
Timepoint [1] 0 0
From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of =5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: =25% increase over baseline/nadir value if baseline PSA =10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of =1 point in median Present Pain Intensity (PPI) from nadir or =25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.
Timepoint [1] 0 0
From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Secondary outcome [2] 0 0
Time to Tumor Progression - Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of =5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.
Timepoint [2] 0 0
From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Secondary outcome [3] 0 0
Percentage of Participants With Overall Objective Tumor Response - Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. 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 had 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.
Timepoint [3] 0 0
From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Secondary outcome [4] 0 0
Time to PSA Progression - Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA =10 ng/mL): increase of =25% (=2 ng/mL) over nadir value, confirmed by second PSA =3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA =10 ng/mL): increase of =25% (=2 ng/mL) over baseline value, confirmed by second PSA =3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (=2 ng/mL) above baseline level, confirmed by second PSA value =3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value =2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.
Timepoint [4] 0 0
From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Secondary outcome [5] 0 0
Percentage of Participants With PSA Response - 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.
Timepoint [5] 0 0
From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
Secondary outcome [6] 0 0
Time to Pain Progression - Pain Progression was defined as an increase of =1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or =25 % increase in the mean AS compared with the baseline score 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. AS 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.
Timepoint [6] 0 0
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Secondary outcome [7] 0 0
Percentage of Participants With Pain Response - Pain response was defined as either a =2-point decrease from baseline median PPI score without increase in AS, or a =50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.
Timepoint [7] 0 0
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Secondary outcome [8] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) - FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.
Timepoint [8] 0 0
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
Secondary outcome [9] 0 0
Change From Baseline in FACT-P:Total Score as a Measure of HRQoL - FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.
Timepoint [9] 0 0
Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)
Secondary outcome [10] 0 0
Percentage of Participants With FACT-P Total Score Response - FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists 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 sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.
Timepoint [10] 0 0
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Secondary outcome [11] 0 0
Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales - The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.
Timepoint [11] 0 0
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Secondary outcome [12] 0 0
Time to Definitive Deterioration of ECOG PS Score From Baseline - The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to =2, or from 2 to =3. Analysis was performed by Kaplan-Meier method.
Timepoint [12] 0 0
From baseline until death or study cut-off date (maximum duration: 48 months)
Secondary outcome [13] 0 0
Time to Definitive Weight Loss by 5% and 10% From Baseline - Time to definitive weight loss was defined as the time to first occurrence of =5% or =10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.
Timepoint [13] 0 0
From baseline until death or study cut-off date (maximum duration: 48 months)
Secondary outcome [14] 0 0
Time to First Definitive Consumption of Narcotic Medication - Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method.
Timepoint [14] 0 0
From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
Secondary outcome [15] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs.
Timepoint [15] 0 0
From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)
Secondary outcome [16] 0 0
Plasma Clearance (CL) for Cabazitaxel - Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.
Timepoint [16] 0 0
Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
Secondary outcome [17] 0 0
Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel - Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.
Timepoint [17] 0 0
Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI

Eligibility
Key inclusion 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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 03. 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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036014 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036013 - Bankstown
Recruitment hospital [3] 0 0
Investigational Site Number 036010 - Box Hill
Recruitment hospital [4] 0 0
Investigational Site Number 036012 - Camperdown
Recruitment hospital [5] 0 0
Investigational Site Number 036008 - Coffs Harbour
Recruitment hospital [6] 0 0
Investigational Site Number 036001 - Concord
Recruitment hospital [7] 0 0
Investigational Site Number 036015 - Elizabeth Vale
Recruitment hospital [8] 0 0
Investigational Site Number 036009 - Fitzroy
Recruitment hospital [9] 0 0
Investigational Site Number 036007 - Garran
Recruitment hospital [10] 0 0
Investigational Site Number 036005 - Heidelberg West
Recruitment hospital [11] 0 0
Investigational Site Number 036002 - Malvern
Recruitment hospital [12] 0 0
Investigational Site Number 036006 - South Brisbane
Recruitment hospital [13] 0 0
Investigational Site Number 036016 - Subiaco
Recruitment hospital [14] 0 0
Investigational Site Number 036003 - Wahroonga
Recruitment hospital [15] 0 0
Investigational Site Number 036004 - Wodonga
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
2050 - Camperdown
Recruitment postcode(s) [5] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [6] 0 0
2137 - Concord
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
2605 - Garran
Recruitment postcode(s) [10] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment postcode(s) [12] 0 0
4101 - South Brisbane
Recruitment postcode(s) [13] 0 0
6008 - Subiaco
Recruitment postcode(s) [14] 0 0
2076 - Wahroonga
Recruitment postcode(s) [15] 0 0
3690 - Wodonga
Recruitment outside Australia
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Minnesota
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Mississippi
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North Carolina
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Ohio
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Rhode Island
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Tennessee
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Texas
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Argentina
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Salta
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Argentina
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Santa Fe
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Belgium
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Antwerpen
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Brussel
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Bruxelles
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Charleroi
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Gent
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Godinne
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Hasselt
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Libramont
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Liège
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Fortaleza
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Ijui
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Salvador
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Brazil
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Sao Jose Do Rio Preto
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Brazil
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Sao Paulo
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Canada
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Greenfield Park
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Canada
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Oshawa
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Canada
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Ottawa
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Canada
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Owen Sound
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Chile
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Santiago
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Chile
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Viña Del Mar
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France
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Avignon Cedex 9
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Hyeres
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La Roche Sur Yon
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Nantes Cedex 2
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Nimes
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Paris
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Reims
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Toulouse Cedex 03
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Toulouse Cedex 09
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Aachen
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Dresden
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Düsseldorf
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Germany
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Erlangen
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Hamburg
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Homburg
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München
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Germany
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Nürtingen
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Germany
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Tübingen
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Germany
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Wuppertal
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Hungary
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Budapest
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Hungary
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Miskolc
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Hungary
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Pécs
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Netherlands
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Arnhem
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Blaricum
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Hoofddorp
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Nijmegen
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Netherlands
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Zwolle
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Lubin
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Olsztyn
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Rybnik
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Siedlce
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Poland
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Torun
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Romania
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Alba Iulia
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Romania
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Baia Mare
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01308580
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries