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    Summary
    EudraCT Number:2012-003305-10
    Sponsor's Protocol Code Number:MO28295
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003305-10
    A.3Full title of the trial
    A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International study assessing two different vismodegib regiments in people with multiple basal cell carcinomas.
    A.4.1Sponsor's protocol code numberMO28295
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 No
    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 namevismodegib
    D.3.2Product code GDC-0449
    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.3.9.4EV 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with multiple basal cell carcinomas (BCCs).
    E.1.1.1Medical condition in easily understood language
    Adult patients with multiple basal cell carcinomas.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 relative reduction from baseline (%) in the number of clinically evident BCCs at a defined time point in two different vismodegib regiments.
    E.2.2Secondary objectives of the trial
    - drop-out rate
    - relative reduction from baseline in total size of BCCs
    - recurrence rate
    - safety
    - patient reported outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written, signed informed consent, including consent for photographs of
    target lesions (required) and non-target lesions (optional)
    - Age ≥ 18 years
    - Have multiple BCCs, including patients with Gorlin syndrome, with
    significant burden of skin disease as manifested by at least 6 clinically
    evident BCCs at the time of randomization, of which three measure 5 mm
    or more in diameter and are considered target lesions. All other lesions
    are considered to be non-target lesions
    - Histopathologic confirmation that at least one of the three target
    lesions is BCC before randomization (2 mm punch biopsy)
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0,
    1, or 2
    - Adequate hematopoietic capacity, hepatic and renal function
    - For women of childbearing potential a negative serum pregnancy test
    within 7 days prior to commencement of dosing is required
    - Women of child-bearing potential must use two methods of acceptable
    contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least
    24 months after completion of study treatment.
    - For male patients with female partners of childbearing potential,
    agreement to use a condom, even after a vasectomy, during sexual
    intercourse with female partners while being treated with
    vismodegib/placebo, and for 2 months after completion of study
    treatment
    - Agreement not to donate blood or blood products during the study and
    for at least 7 months after completion of study treatment
    - For male patients, agreement not to donate sperm during treatment
    and for at least 2 months after discontinuation of treatment
    E.4Principal exclusion criteria
    - Inability or unwillingness to swallow capsules and to comply with
    study procedures
    - Pregnancy or breastfeeding
    - Any metastatic BCC
    - Locally advanced BCC lesion that is considered to be inoperable or to
    have a medical contraindication to surgery in the opinion of a Mohs
    surgeon, dermatologic surgeon, head and neck surgeon, surgical
    oncologist, or plastic surgeon.
    - Recent (i.e., within the past 28 days prior to randomization) or current
    participation in another experimental drug study
    - Uncontrolled medical illness, including advanced malignancies, at the
    discretion of the Investigator
    - History of other disease, metabolic dysfunction, physical examination
    finding, or clinical laboratory finding giving reasonable suspicion of a
    disease or condition that contraindicates the use of an investigational
    drug or that might affect interpretation of the results of the study or
    renders the patient at high risk for treatment complications
    - Known or suspected alcohol abuse in the opinion of the investigator
    - Patients with one of the following known rare hereditary conditions:
    galactose intolerance, primary hypolactasia or glucose-galactose
    malabsorption
    E.5 End points
    E.5.1Primary end point(s)
    Relative reduction from baseline (%) in the number of clinically evident BCCs at a defined time point in two different vismodegib regiments
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 73
    E.5.2Secondary end point(s)
    Drop-out rate, relative reduction from baseline in total size of BCCs, recurrence rate, safety, patient reported outcomes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Phase (Week 9, 17, 25, 33, 41, 49, 57 and 65), Week 73, 85, 97 and 125
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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
    two treatment regimens (alternance of vismodegib and placebo)
    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 Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Brazil
    Canada
    France
    Germany
    Italy
    Mexico
    Netherlands
    Russian Federation
    Spain
    Switzerland
    United Kingdom
    United States
    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
    LPLV (the end of study visit will be performed after 52 weeks of follow-up after completion of the 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 200
    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)
    Post study treatment is left to the Investigator's discretion. This may include potential treatment with commercial Erivedge (when approved and available in respective country).
    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 Decision2013-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-31
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