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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-000542-35
    Sponsor's Protocol Code Number:RDD490
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-15
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2012-000542-35
    A.3Full title of the trial
    Phase II multicentre study assessing the efficacy of Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study assessing if a chemotherapy drug called Cabazitaxel is effective in Patients with certain type of breast cancer (HER2 negative) that has spread to brain that is un treatable.
    A.3.2Name or abbreviated title of the trial where available
    CiPHER
    A.4.1Sponsor's protocol code numberRDD490
    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 SponsorThe Clatterbridge Cancer Centre NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRUK Liverpool Cancer Trials Unit
    B.5.2Functional name of contact pointCharlotte Rawcliffe
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Liverpool
    B.5.3.2Town/ city1st Floor Block C Waterhouse Building
    B.5.3.3Post codeL693GL
    B.5.4Telephone number01517948167
    B.5.5Fax number0151 794 8930
    B.5.6E-mailclr001@liverpool.ac.uk
    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 Jevtana
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCabazitaxel (Jevtana)
    D.3.4Pharmaceutical form Concentrate and diluent 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.3.8INN - Proposed INNCabazitaxel
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeXRP6258
    D.3.9.3Other descriptive nameJevtana
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Her-2 negative breast cancer with brain metastases
    E.1.1.1Medical condition in easily understood language
    Her-2 negative breast cancer that has spread to the brain
    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 10027475
    E.1.2Term Metastatic breast 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 10055113
    E.1.2Term Breast 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
    The primary aim of this study is to determine whether there is evidence for Cabazitaxel increasing 18 week survival from 67% to 81%.
    Sanofi Ltd. are funding the drug & management costs for this Phase II study. GCSF is being provided by Amgen.This study is designed to assess the feasibility of Cabazitaxel use in breast cancer with brain metastases.

    Primary outcome: Overall proportion surviving at 18 weeks (i.e. up to 6 cycles of treatment) from registration
    E.2.2Secondary objectives of the trial
    Secondary outcomes:

    • Progression-free survival (PFS) – defined as the time from registration to the first of one of the following: development of disease progression or death from any cause)
    • Overall response for extracranial visceral metastases (ORv) as defined in RECIST 1.0, recorded from the start of treatment to 18 weeks
    • Overall response for CNS lesions (ORc) defined as a best response of at least PR, recorded from the start of treatment to 18 weeks
    • Acute toxicity (CTCAE v4) after each treatment cycle up to 18 weeks (for the purposes of safety, toxicity will be assessed up until 28 days after the last dose of study treatment)
    • Time to radiotherapy (measured from treatment start date until commencement of radiotherapy)
    • Time to neurological deterioration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • First or second line metastatic HER2 negative* breast cancer
    • Oligometastatic brain disease that is unsuitable for surgical resection and/or stereotactic radiosurgery
    • Age ≥18 years
    • ECOG performance status 0-2
    • Diagnosis of metastatic HER2-negative breast cancer
    • At least one measurable target lesion (RECIST 1.0) in the brain (unsuitable for resection) identified by CT scan or MRI within 21 days of registration.
    • Females of child bearing potential who have a negative pregnancy test prior to study entry
    • Agree to use adequate contraception which they agree to continue for 12 months after the study treatment
    • Ability and capacity to comply with study and follow-up procedure
    • Able to provide written informed consent

    Patients with ER+ve or ER-ve disease are eligible for the study
    Patients with meningeal disease are eligible provided they fit the other criteria. Extracranial disease is not a requirement of this study.
    E.4Principal exclusion criteria
    • Received prior radiotherapy/radiosurgery to the brain (radiotherapy may be offered on disease progression)
    • Received >2 lines of chemotherapy for metastatic recurrent disease (adjuvant treatment is permitted) prior to registration
    • Received any chemotherapy after the diagnosis of brain metastases
    • Previous hormone therapy if it will not be discontinued before Cabazitaxel treatment
    • Patients who have received an increasing dose of steroids to control CNS symptoms within 14 days of registration (steroid use is permitted only when patient is stable at a specific dose at the time of screening)
    • Visceral metastases with no recorded brain metastases
    • Pregnancy or lactation
    • Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 28 days prior to registration
    • Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
    • Grade ≥2 peripheral motor and/or sensory neuropathy
    • Grade ≥2 mucositis oral
    • History of severe hypersensitivity reaction (≥grade 3) to taxanes
    • History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80-containing drugs
    • Other concurrent serious illness or medical conditions which make it undesirable for the patient to enter the trial (including uncontrolled diabetes mellitus)
    • Inadequate organ and bone marrow function as evidenced by:
    g. Haemoglobin < 9.0 g/dL
    h. Absolute neutrophil count < 1.5 x 109/L,
    i. Platelet count <100 x 109/L,
    j. AST/SGOT and/or ALT/SGPT >2.5 x ULN;
    k. total bilirubin >1.0 x ULN,
    l. Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded (18). See Appendix B
    • Active infection requiring systemic antibiotic or anti – fungal medication.
    • Participation in another clinical trial with any investigational drug within 30 days prior to registration
    • Administration of potent inhibitors and inducers of P450 3A4/5 enzymes within 7 days of registration, or planned concurrent administration whilst on study. This excludes steroid treatment which is standard care treatment for patients with brain metastases
    • Concomitant vaccination with live attenuated vaccines
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome will be Overall response which is defined as a best response of at least PR for CNS lesions, recorded from the start of treatment to completion of 6 cycles of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall proportion surviving at 18 weeks (i.e. up to 6 cycles of treatment) from registration
    E.5.2Secondary end point(s)
    • Progression-free survival (PFS) – defined as the time from registration to the first of one of the following: development of disease progression or death from any cause)
    • Overall response for extracranial visceral metastases (ORv) as defined in RECIST 1.0, recorded from the start of treatment to 18 weeks
    • Overall response for CNS lesions (ORc) defined as a best response of at least PR, recorded from the start of treatment to 18 weeks
    • Acute toxicity (CTCAE v4) after each treatment cycle up to 18 weeks (for the purposes of safety, toxicity will be assessed up until 28 days after the last dose of study treatment)
    • Time to radiotherapy (measured from treatment start date until commencement of radiotherapy)
    • Time to neurological deterioration
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of study is defined as 12 months after the last patient’s last dose of study treatment.

    All patients will be followed up following the end of treatment cycle 6 for as long as possible.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    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 No
    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
    The end of study is defined as 12 months after the last patient’s last dose of study treatment.
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    Not applicable - Cabazitaxel will be provided to patients until disease progression, unacceptable toxicity or withdrawal of consent. Once they end Cabazitaxel treatment, they will be provided with standard of care treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-07-25
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