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    Summary
    EudraCT Number:2015-002184-42
    Sponsor's Protocol Code Number:TED12689
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-02-19
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-002184-42
    A.3Full title of the trial
    A Phase 1-2 Dose Finding, Safety and Efficacy Study of Cabazitaxel in
    Pediatric Patients with Refractory Solid Tumors Including Tumors of the
    Central Nervous System
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Cabazitaxel in Pediatric Patients with Refractory
    Solid Tumors Including Central Nervous System Tumors
    A.4.1Sponsor's protocol code numberTED12689
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1128-5704
    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 SponsorSanofi-aventis
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-aventis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis Research and Development
    B.5.2Functional name of contact pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.4CountryUnited States
    B.5.6E-mailContact-US@sanofi.com
    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 U.S. LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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
    D.3.2Product code XRP6258
    D.3.4Pharmaceutical form Concentrate 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 nameCABAZITAXEL
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10061268
    E.1.2Term Malignant nervous system neoplasm
    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
    Phase 1 Part:

    To determine the dose limiting toxicity (DLT) and the maximum
    tolerated dose (MTD) of cabazitaxel as a single agent in pediatric
    patients with recurrent or refractory solid tumors including tumors of
    the central nervous system.

    Phase 2 Part:

    To determine the objective response rate (complete and partial
    response) and the duration of response to cabazitaxel as a single agent
    in patients with recurrent or refractory high grade glioma (HGG) or
    diffuse intrinsic pontine glioma (DIPG).
    E.2.2Secondary objectives of the trial
    Phase 1 Part:

    To characterize the safety and tolerability of cabazitaxel in patients
    with recurrent or refractory solid tumors including tumors of the
    central nervous system.
    To characterize the pharmacokinetic (PK) profile of cabazitaxel in
    patients with recurrent or refractory solid tumors including tumors of
    the central nervous system.
    To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in patients with recurrent or refractory solid tumors
    including tumors of the central nervous system.

    Phase 2 Part:

    To characterize the safety and tolerability of cabazitaxel in patients
    with recurrent or refractory HGG or DIPG.
    To estimate progression free survival in patients with recurrent or
    refractory HGG or DIPG.
    To estimate overall survival in patients with recurrent or refractory
    HGG or DIPG.
    To characterize the plasma PK profile of cabazitaxel in patients with
    recurrent or refractory HGG or DIPG.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To characterize the PK profile of cabazitaxel in cerebrospinal fluid
    (optional) in patients with brain tumors.
    E.3Principal inclusion criteria
    Phase 1 Part (dose escalation):

    Patients with a histologically confirmed
    solid tumor including tumors of the central nervous system that is
    recurrent or refractory and for which no further effective standard
    treatment is available. All patients must have measurable disease.
    Patients with diffuse pontine glioma are eligible without a biopsy after
    evidence of progressive disease post radiation therapy.

    Phase 2 Part (safety and activity):

    Patients with recurrent or refractory
    high grade glioma or diffuse intrinsic pontine glioma for whom no
    further effective therapy is available. All patients must have
    measurable disease. Patients with diffuse pontine glioma are eligible
    without a biopsy after evidence of progressive disease post radiation
    therapy. Patients with a grade III or grade IV glioma must have
    pathologic conformation either at the time of initial diagnosis or at the
    time of recurrence.
    Patients aged ≥2 years and ≤18 years
    Patients should meet the body surface area (BSA) requirements to be
    eligible:
    a) Minimal BSA requirements for a particular dose level;
    b) During the Phase 1 part patients must have a BSA <2.1 m² at the
    time of enrollment
    c) During the Phase 2 part patients with a BSA ≥2.1 m² will be eligible,
    however the actual dose of cabazitaxel for these patients will be
    adjusted to a maximum dose calculated with (capped at) the BSA of 2.1
    m²
    Performance status by:
    a) Lansky score ≥60 (patients ≤10 years of age)
    b) Karnofsky score ≥60% (patients >10 years of age)
    Patients who are unable to walk because of paralysis, but who are
    mobile in a wheelchair, will be considered ambulatory for the purpose
    of assessing the performance score
    Patients must have adequate liver, renal and marrow function as
    defined below:
    a) Total bilirubin ≤1.0 x the upper limit of normal (ULN) for age
    b) AST (SGOT) and ALT (SGPT) ≤2.5 x ULN
    c) Serum creatinine ≤1.5 x ULN for age or creatinine clearance ≥60
    mL/min/1.73 m²
    d) Absolute neutrophil count ≥1.0x10^9 /L
    e) Platelets ≥75x10^9/L (transfusion independent)
    f) Hemoglobin ≥8.0 g/dL (can be transfused)
    Female patients of child-bearing potential must have a negative
    pregnancy test ≤7 days before starting cabazitaxel treatment.
    Male and female patients of reproductive potential must agree to use
    adequate contraception prior to study entry, for the duration of study
    participation and for 6 months following the last dose of cabazitaxel.
    Written informed consent/assent prior to any study-specific
    procedures. Consent must be obtained from the patient and/or
    parent(s) or legal guardian(s) and the signature of at least one parent or guardian will be required. Investigators will also obtain assent of
    patients according to local, regional or national guidelines.
    Patients must have recovered from the acute toxic effects of all prior
    therapy to ≤ grade 1before entering the study
    E.4Principal exclusion criteria
    Prior treatment within the following timeframes:
    a) Systemic anti-cancer treatment within 3 weeks (6 weeks for
    nitrosourea, mitomycin and monoclonal antibodies including
    bevacizumab)
    b) Surgery or smaller field radiation therapy within 4 weeks
    c) Treatment with an investigational agent within 4 weeks or within 5
    half-lives of the agent, whichever is longer
    Craniospinal or other large field radiation therapy (defined as >25% of
    bone marrow irradiated) within 6 months prior to the first dose.
    Prior systemic radioisotope therapy (this does not include diagnostic
    imaging or radioimmunoconjugates lacking myelosuppressive
    properties) or total body irradiation.
    Prior bone marrow or stem cell transplant
    Patients with any clinically significant illness that, in the investigator's
    opinion, cannot be adequately controlled with appropriate therapy,
    would compromise a patient's ability to tolerate cabazitaxel or result in
    inability to assess toxicity. This includes, but is not limited to
    uncontrolled intercurrent illness including ongoing or active infection,
    cardiac disease, renal impairment, planned surgery or psychiatric
    illness/social situations that would limit compliance with study
    requirements.
    Known human immunodeficiency virus (HIV) infection or acquired
    immunodeficiency-syndrome (AIDS)-related disease
    Known history of hepatitis C or known active hepatitis B infection.
    Pregnant or breast feeding women
    Treatment with strong inhibitors or strong inducers of CYP3A4 or
    enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to
    first dose of cabazitaxel and for the duration of study. Non-EIAEDs are
    permitted.
    Known history of hypersensitivity to taxanes or polysorbate 80 or GCSF.
    Participation in another interventional clinical trial and/or concurrent
    treatment with any investigational drug.
    Patients not able to comply with scheduled visits, treatment plans,
    laboratory tests, and other study procédures.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Maximally tolerated dose of cabazitaxel
    2 - Antitumor activity by evaluating the objective response rate (ORR)
    for patients with recurrent or refractory high grade glioma (HGG) or
    diffuse intrinsic pontine glioma (DIPG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 18 months
    E.5.2Secondary end point(s)
    1 - Number of adverse events for patients with recurrent or refractory
    solid tumors including tumors of the central nervous system
    2 - Pharmacokinetics: AUC
    3 - Pharmacokinetics: CL
    4 - Pharmacokinetics: Vss
    5 - Pharmacokinetics: Cmax
    6 - Preliminary anti-tumor activity in patients with recurrent or
    refractory solid tumors including tumors of the central nervous system
    7 - Progression free survival in patients with recurrent or refractory
    HGG or DIPG
    8 - Overall survival in patients with recurrent or refractory HGG or
    DIPG
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 36 months
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding in children
    E.7.2Therapeutic exploratory (Phase II) No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 57
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 29
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects/patients who are considered by law to be minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 57
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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