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    Summary
    EudraCT Number:2013-004338-13
    Sponsor's Protocol Code Number:2013_36
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-004338-13
    A.3Full title of the trial
    Phase II study evaluating the interest of Vismodegib as neo-adjuvant treatment of basal cell carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the interest of Vismodegib before surgery in the treatment of basal cell carcinoma
    A.3.2Name or abbreviated title of the trial where available
    VISMONEO
    A.4.1Sponsor's protocol code number2013_36
    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 SponsorCHRU De Lille
    B.1.3.4CountryFrance
    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 supportROCHE
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Univeristaire De Lille
    B.5.2Functional name of contact pointMIRAKOVSKA Liubinka & MEDDOUR Damia
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Oscar Lambret
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    B.5.6E-maildrc@chru-lille.fr
    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 ERIVEDGE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    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 nameERIVEDGE
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVISMODEGIB
    D.3.9.1CAS number 879085-55-9
    D.3.9.2Current sponsor codeGDC-0449
    D.3.9.3Other descriptive nameVISMODEGIB
    D.3.9.4EV Substance CodeSUB32354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Male and female patients at least 18 years of age with histologically confirmed diagnoses of locally advanced BCC
    E.1.1.1Medical condition in easily understood language
    patients with confirmed skin cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10004146
    E.1.2Term Basal cell carcinoma
    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 assess the proportion of BCC patients (in intent to treat) with down-staging of surgical procedure after Vismodegib neoadjuvant treatment (with a maximum treatment period of 10 months).

    E.2.2Secondary objectives of the trial
    1.Estimation of the percentage of patients with locally advanced BCC having a down-staging of surgical procedures after at least 4 months of treatment with Vismodegib
    2.Assessment of clinical benefits for patients treated with Vismodegib by an Independent panel of experts
    3.Medico-economical assessment of the related medical care
    4.Assessment of treatment toxicity
    5.Quality of life assessment
    6. Evaluation of the tumor recurrence rate after 3 years of follow-up
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with BCC, which surgery stage is A, B or C (cf. Appendix 3: Definition of surgery stages), with a diameter ≥ 3cm in zones at intermediate risk of tumor recurrence and a BCC with a diameter of ≥ 2 cm in the zones at higher risk of tumor recurrence. According to the HAS recommendations, two zones are taken into consideration:
    • Zones at intermediate risk of tumor recurrence: forehead, cheek, chin, neck and scalp
    • Zones at higher risk of tumor recurrence: nose and periorificial sites of the cephalic extremity
    2. The decision to include the patient in this study should be taken during the Pluridisciplinary Committee Meeting (RCP). During this RCP, the radiotherapy should be considered as an inadequate treatment.
    3.Written informed consent
    4.Age ≥ 18 years
    5.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2
    6.At least one histologically confirmed lesion
    7.Patients with Gorlin syndrome may enroll in this study but must meet the other inclusion criteria
    8.Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1)
    9.Adequate organ function, as evidenced by the following laboratory results:
    • Hemoglobin > 8.5 g/dL
    • Granulocyte count ≥ 1000/μL
    • Platelet count ≥ 75,000/μL
    • Aspartate transaminase (AST [SGOT]) and alanine transaminase (ALT [SGPT]) ≤ 3 × upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome

    10.Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
    11.Women of childbearing potential must use one highly-effective method of contraception and one barrier method of contraception during treatment and for 24 months after the final dose. Highly-effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, or intra-uterine devices; refer to Appendix 8 for more details). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, and postovulation methods] and withdrawal are not acceptable methods of contraception.).
    12.For male patients with female partners of childbearing potential, agreement top use a condom with spermicide, even after vasectomy, during sexual intercourse with partners while being treated with Vismodegib and for two months after completion of study treatement.
    13.For male patients, agreement not to donate semen during the study and for 24 months after discontinuation of Vismodegib
    14.Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of Vismodegib.
    15.Life expectancy > 12 weeks
    16.Patients covered by a Health Insurance System


    E.4Principal exclusion criteria
    1.Inability or unwillingness to swallow capsules
    2.Patients with BCC situated out of the head or the neck area
    3.Pregnancy or lactation
    4.Concurrent non–protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy or photodynamic therapy
    5.Chemotherapy within 4 weeks prior to enrollment
    6.Participation in another clinical trial within 4 weeks prior to enrollment
    7.Radiotherapy within 6 months prior to enrolment
    8.Metastatic BCC
    9.Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
    10.History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk from treatment complications.
    11.Patients with a rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption (according to the product SmPC).
    12.Patients unable or unwilling to comply with the protocol requirements
    13.Patients in emergency situations
    14.Patients kept in detention

    E.5 End points
    E.5.1Primary end point(s)
    To assess the change in surgery stages (comparison of the surgery stages before and after the treatment with Vismodegib
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment visit
    E.5.2Secondary end point(s)
    1.Percentage of patients with locally advanced BCC with down-staging of surgical procedures after at least 4 months treatment with Vismodegib
    2.Gravity index related to the surgical or functional results (global score) and score of the clinical benefits at BOR.
    3.Comparison of the costs of the usual care and those induced by the of the treatment with Vismodegib
    4.The NCI-CTCAE, v4.0
    5.Quality of life assessment using the Skindex-16 Quality of Life
    6. Evaluation of the tumor recurrence rate after 3 years of follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.End of treatment visit
    2.End of study
    3.Each study visit
    4.Quality of life assessment during the treatment period (cycle 1, cycle 3 and cycle 6) and end of treatment visit
    5. Tumor recurrence rate after 3 years of follow-up
    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.8.2.4Number 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 concerned33
    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 the trial correspond to the last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned 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.1.3Elderly (>=65 years) Yes
    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 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
    Patients with Gorlin syndrome may enroll in this study. The Gorlin syndrom may be associated to an intellectual deficit.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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)
    usual care
    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 Decision2014-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-08
    P. End of Trial
    P.End of Trial StatusOngoing
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