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    Summary
    EudraCT Number:2011-004178-27
    Sponsor's Protocol Code Number:KS-01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2011-004178-27
    A.3Full title of the trial
    A Randomized, Open Label, Multicenter, Phase II, 2-Arm Study comparing the conventional 3 weekly schedule of Jevtana (Cabazitaxel) with a weekly regimen in patients with Metastastic Castration Resistant Prostate Cancer
    ConWeCab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Trial of Standard Treatment with Cabazitaxel Once Every Three Weeks Compared to a Regimen of Cabazitaxel Given Weekly for Five of Six Consecutive Weeks in Patients With Prostate Cancer that has Spread
    A.3.2Name or abbreviated title of the trial where available
    ConCab
    A.4.1Sponsor's protocol code numberKS-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStockholm Läns Landsting
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressRadiumhemmet, Karolinska Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number468517-763 77
    B.5.5Fax number468306989
    B.5.6E-mailjohanna.vernersson@karolinska.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cabazitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJevtana
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeL01CD04
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Castration Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer that has spread beyond the prostate and no longer responds to hormonal therapies
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036920
    E.1.2Term Prostate cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if a weekly regime improves tolerability of cabazitaxel compared to the standard 3 week regimen
    E.2.2Secondary objectives of the trial
    To compare drug efficacy, drug safety and patient quality of life in a weekly and three week scheduling of cabazitaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Histological confirmed prostate cancer
    • Macroscopic metastatic disease
    • Prior treatment with Docetaxel
    • Castration resistant disease defined as :
    Serum testosterone (< 0.5 ng/ml) and :
    * Increase in measurable disease (Recist 1.1) Or
    * Appearance of new lesions
    Or
    * Rising PSA
    E.4Principal exclusion criteria
    • Less than 21 days since prior treatment with chemotherapy,
    • Less than 14 days since radiotherapy or surgery to the start of cabazitaxel
    • Less than 4 weeks after stopping abiraterone or other new anti-hormonal drugs
    • Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
    • Adverse events from previous cancer therapies > grade 1 (NCI CTCAE V4.03) with the exception of alopecia. (With respect to peripheral neuropathy grade 2 is acceptable)
    • Age less than 18 years
    • ECOG performance status > 2
    • Known CNS malignancy
    • Within 6 months of randomization: myocardial infarction , unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV
    • Within 3 months prior to randomization: treatment resistant peptic ulcer disease, infectious or inflammatory bowel disease, pulmonary embolism
    • Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
    • Unable to comply with study procedures
    • History of hypersensitivity to docetaxel or polysorbate 80
    • Inadequate organ and bone marrow function as defined below
    • Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 ( eg simvastatin, keotconazole. For comprehensive list please see Appendix ) a one week wash out period is necessary for patients who are already on these treatments).
    • Patients with reproductive potential not implementing accepted and effective method of contraception.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to compare dose intensity of the 3-weekly and the weekly schedules after 18 weeks of planned therapy.

    The defininition of dose intensity is based upon the total dose the patient actually receives in relation to the total dose that the patient is expected to receive by 18 weeks of therapy. This definition applies to patients discontinuing therapy for reasons other than disease progression. For patients stopping treatment due to lack of efficacy, dose-intensity is based on the total dose received over the interval of time from the start of chemotherapy until the date of the last dose given. Both treatment arms are designed to have the same dose-intensity at the outset ie 150 mg/m2 as the total dose given over 18 weeks representing 100 % dose intensity in relation to the planned total dose at the start of treatment. Dose delays, dose reductions and especially stopping treatment for reasons other than disease progression will be mirrored by lowering the dose given in relation to the dose planned and as such is an objective measure of drug tolerability.
    E.5.1.1Timepoint(s) of evaluation of this end point
    By definition all patients discontinuing treatment before 18 weeks from the start of therapy or patients who reach 18 weeks of therapy will be evaluated for the primary endpoint.
    E.5.2Secondary end point(s)
    Overall Survival

    Disease Specific Survival

    Progression Free Survival
    Progression free survival is defined as the length of time from randomization to the first documentation of one of the following:
    PSA progression
    or
    Pain progression
    or
    Death due to any cause
    or
    Radiological disease progression

    PSA progression is defined as either a 25% increase (at least 2 ng/ml) from baseline in patients not achieving a prior > 50% decrease in PSA or a 50% increase in PSA (at least 2 ng/ml) above the nadir value in patients who have achieved a prior > 50% decrease in PSA. A confirmatory PSA will be taken at least 3 weeks later. During the first twelve weeks of therapy increases in PSA may reflect treatment induced PSA-flare and can therefore be misleading. A rising PSA, during the first 12 weeks of treatment, without clinical and/or radiological signs of progression is therefore not considered as disease progression.
    Pain will be assessed using the Present Pain Intensity (PPI) scale (see appendix). Pain assessment will be made at baseline and before each treatment until the patient discontinues therapy. Diaries will be used to assess analgesic consumption. Pain progression is defined as
    1) the need for palliative radiotherapy if the symptoms giving rise to radiotherapy were not present at baseline or
    2) they were present but the pain have worsened to the extent that the physician in question feels that it is in the patients best interest to radiate. Pain progression exists when the patients`
    3) median PPI score increases by at least one point from nadir or
    4) there is an increase in analgesic consumption of 25% over baseline.
    Radiological disease progression and tumour response are defined according to Recist 1.1 criteria. If lesions are present only in bone and assessed by bone scan, size and intensity of target lesions may not be used to determine disease progression. The appearance of two new lesions confirmed six weeks later is considered as disease progression.

    PSA Response
    Only considered after 12 weeks of treatment. PSA response is defined as a 50% or greater decline in serum PSA from baseline given that baseline PSA is at least 10 ng/ml.

    Quality of Life
    Quality of life will be assessed using the FACT-P-T self administered questionnaire. Patients will complete the questionnaire at baseline and the day before the three week general assessments. The questionnaire is to be answered at home.

    Dose Intensity at 24 and 36 weeks
    Dose intensity is defined in the same manner as for the primary endpoint.

    Tolerability
    The primary endpoint in this protocol is chosen as a means of estimating tolerability. Another estimate of tolerability will be made by examining the frequency of patients requiring a dose reduction, a dose delay as well as patients. At each cycle of therapy evaluation, three questions will apply:
    Is the patient stopping treatment for reasons of toxicity and not disease progression?
    Is there a dose delay due to toxicity?
    Is there dose reduction?

    If the answer is yes to any of the three questions, this will be recorded as an event. A patient may subsequently have more than one event, (i.e. dose delay (1 ev.), dose reduction (1 event), stopping treatment (1 event)

    Duration of Treatment
    Duration of treatment is defined as the length of time from the first day of treatment to the last day of treatment with cabazitaxel.
    Efficacy of cabazitaxel in relation to the total cumulative dose of prior treatment with docetaxel
    Efficacy endpoints described above will be correlated to the cumulative dosage of docetaxel prior to study treatment

    Frequency and time to skeletal related events
    E.5.2.1Timepoint(s) of evaluation of this end point
    When the last patient enrolled has either stopped treatment prior to week 18 or has reached the 18 th week of therapy all patients will be evlauated for all endpoints.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    the comparator is standard 3 weekly cabazitaxel
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Trail is stopped when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date due to toxicity or disease progression.

    Interim analysis when 43 patients have been randomised and the last patient has passed the time interval stipulated for the primary endpoint. If arm B has a lower dose intensity than arm A at a level of statistical significance of 0.05 or less, the independent data monitoring committee will prematurely end the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    care after participation in this trial is the expected normal treatment of metastatic prostate cancer
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-24
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