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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01308580




Registration number
NCT01308580
Ethics application status
Date submitted
3/03/2011
Date registered
4/03/2011
Date last updated
17/04/2017

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)
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)
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
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
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
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
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
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
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)
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
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
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
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
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
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
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)
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
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
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
Sex
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
1200
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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United States of America
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Alabama
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Arkansas
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Minnesota
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Mississippi
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Nebraska
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North Carolina
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Ohio
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Tennessee
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Argentina
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Santa Fe
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Antwerpen
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Bruxelles
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Charleroi
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Gent
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Hasselt
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Libramont
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Liège
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Hamburg
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Homburg
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München
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Nürtingen
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Tübingen
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Wuppertal
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Budapest
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Miskolc
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Pécs
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Korea, Republic of
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Seongnam
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Seoul
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Netherlands
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Hoofddorp
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Nijmegen
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Zwolle
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Lubin
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Baia Mare
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Bucuresti
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Focsani
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Hunedoara
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Onesti
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Tula
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Durban
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South Africa
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Pretoria
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Sabadell
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Sevilla
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Taipei
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Tunisia
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Sfax
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Tunisia
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Sousse
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Tunisia
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Tunis
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Turkey
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Antalya
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Turkey
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Bornova
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Turkey
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Istanbul
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United Kingdom
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Birmingham
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United Kingdom
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Colchester
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United Kingdom
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Glasgow
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United Kingdom
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Guildford
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
State/province [124] 0 0
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01308580