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    Summary
    EudraCT Number:2013-001550-98
    Sponsor's Protocol Code Number:C-GBM(XRP6258)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-001550-98
    A.3Full title of the trial
    Prospective controlled phase 2 trial of cabazitaxel in patients with temozolomide refractory glioblastoma multiforme (GBM)
    - The C-GBM Study -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective controlled phase 2 trial of cabazitaxel in patients with temozolomide refractory glioblastoma multiforme (GBM)
    - The C-GBM Study -
    A.4.1Sponsor's protocol code numberC-GBM(XRP6258)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01866449
    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 SponsorUniversity Hospital of Ulm
    B.1.3.4CountryGermany
    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 GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversity Hospital of Ulm
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Ulm
    B.5.2Functional name of contact pointClinical Trials Office IM III
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Einstein-Allee 23
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number+4973150045901
    B.5.5Fax number+4973150044505
    B.5.6E-mailcgbm.innere3@uniklinik-ulm.de
    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 AuthorisationEuropean Union
    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 XRP-6258
    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.3.11 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
    •Patients with diagnosis glioblastoma multiforme (GBM) WHO grade IV ;
    •Progression during or within 6 months after last temozolomide treatment;
    •Time since last temozolomide > 21 days
    E.1.1.1Medical condition in easily understood language
    •Patients with diagnosis glioblastoma multiforme (GBM) WHO grade IV
    •Patienten mit histologisch gesichertem Glioblastoma multiforme (GBM) WHO Grad IV
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    • Response after 12 weeks
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • Impact on progression and overall survival
    • Pharmacokinetics of cabazitaxel in patients with and without concomitant anticonvulsive medication with respect to induction of CYP3A
    • Assessment of quality of life, determined by assessment with EORTC QLQ questionnaires (C30 and BN20), and neurocognitive functioning, determined by repeated standardized measurements using MMSE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Patients with diagnosis glioblastoma multiforme (GBM) WHO grade IV (histologically confirmed by a pathologist)
    · Progression during or within 6 months after last temozolomide treatment
    · Time since last temozolomide > 21 days
    · Prior external beam radiotherapy (54 to 62 Gy), no option for subsequent radiotherapy
    · No clinical and radiological signs of intracerebral inflammation (in pre-study MRI not older than 4 weeks)
    · Patients > 18 years of age.
    · ECOG performance status of ≤ 2 (stable over 4 weeks prior to study entrance)
    · Female patients of childbearing potential with a negative pregnancy test within 7 days of initiation of study treatment. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
    · Male and female patients of reproductive potential who agree to employ an effective method of birth control throughout the study and for up to 6 months following discontinuation of study drug.*
    · Signed informed consent prior to initiation of any study procedure
    E.4Principal exclusion criteria
    · Female patients who are pregnant or breast-feeding
    · History of severe hypersensitivity reaction (≥grade 3) to any component of the investigational drugs or excipients (allergy to or other intolerability of gadolinium, docetaxel, cabazitaxel or polysorbate 80 containing drugs)
    · Unable to undergo Gd-MRI
    · Time since external beam radiotherapy <12 weeks
    · Patients who have been treated with any investigational agent(s) within 28 days of the first day of administration of study drug.
    · Current active second malignancy other than non-melanoma skin cancers and post-treatment of localized prostate cancer. Patients are not considered to have a currently active malignancy if they are in complete remission for > 3 years prior to study
    · Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
    · Known HIV infection, active Hepatitis B or C infection
    · Any serious and/or unstable pre-existing psychiatric or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
    · Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity (except alopecia) and delayed hematological recovery following last temozolomide cycle
    · Additional anti-cancer treatment for GBM other than study drug and supportive measures (i.e. dexamethason)
    · Inadequate organ and bone marrow function as evidenced by:
    a) Hemoglobin <9.0 g/dL
    b) Absolute neutrophil count <1.5 x 109/L,
    c) Platelet count <100 x 109/L,
    d) AST/SGOT and/or ALT/SGPT >2.5 x ULN;
    e) Total bilirubin >1.0 x ULN,
    f) 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
    E.5 End points
    E.5.1Primary end point(s)
    • Response including SD, PR or CR determined by MRI (modified RANO criteria)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The response to treatment will be evaluated continuously after every two treatment cycles (in 42 day intervals) using the response criteria defined by the Response Assessment in Neuro-Oncoloy Working Group (RANO, Wen et al., 2010; Appendix
    III).
    E.5.2Secondary end point(s)
    Primary Endpoint
    · Overall and progression-free survival
    · Safety and tolerability
    · Pharmacokinetics data concerning drug interactions (i.e. CYP3A
    induction)
    · Quality of life and neurocognitive functioning

    Safety endpoints
    · Rates of deaths within 12 weeks
    · Hematological and non hematological toxicity grade ≥ 2 according to CTCAE V4.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    A first safety assessment will be performed after treatment of 12 patients. Safety assessment will be based on an observation period of each patient of at least four cycles (12 weeks).
    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 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 No
    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 concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state46
    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)
    After finishing all study relevant procedures, therapy and follow-up period, the patient will be followed in terms of routine aftercare and treated if necessary by the primary responsible hematologic-oncologic center.
    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 Decision2013-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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