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    Summary
    EudraCT Number:2011-001789-16
    Sponsor's Protocol Code Number:PenCTU/2011/CTIMP-005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-17
    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 number2011-001789-16
    A.3Full title of the trial
    Investigation of the intra-tumoural concentration and activity of sorafenib in cutaneous schwannomas
    A.3.2Name or abbreviated title of the trial where available
    Sorafenib in NF2
    A.4.1Sponsor's protocol code numberPenCTU/2011/CTIMP-005
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPlymouth Hospital NHS 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    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.3.4Pharmaceutical form Film-coated tablet
    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 INNsorafenib (as tosylate)
    D.3.9.3Other descriptive nameNexavar
    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 number200mg
    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
    Neurofibromatosis, type 2 (acoustic neurofibromatosis)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10029271
    E.1.2Term Neurofibromatosis, type 2 (acoustic neurofibromatosis)
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are: To measure steady-state plasma concentrations and intra-tumoural concentrations of sorafenib in cutaneous schwannomas after 11 days of oral dosing with sorafenib To investigate indices of molecular activity of sorafenib in tumour and blood, before and after treatment with sorafenib.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are: To assess whether target inhibition with oral sorafenib in plasma in NF2 patients with CS can act as a biomarker To analyze if tumour pain occurs after treatment with oral sorafenib in NF2 To identify early drug induced changes in the MRI scan (Manchester only)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (a)written informed consent (b)diagnosis of NF2 (c)over 18 years in age (d)presence of more at least two cutaneous schwannomas >1cm3 in area and accessible for biopsy (e)WHO/ECOG Performance Status 0 or 1 (f)adequate bone marrow function within 28 days prior to the baseline visit o WBC > 3.4x109/l o platelets > 99x109/l (g)adequate renal function within 28 days prior to the baseline visit o creatinine < 2.5 x upper limit of normal (h)adequate hepatic function within 28 days prior to the baseline visit o LFT < 1.5 x upper limit of normal o serum amylase < 1.5 x upper limit of normal o prothrombin (PT) or INR (International Normalized Ratio) and Prothrombin Time (PTT) < 1.5 x upper limit of normal (i)able to swallow tablets (j)patients with the potential for pregnancy or impregnating their partner must agree to use acceptable methods of birth control to avoid conception o female patients who are not using hormonal contraception must agree to employ two barrier methods of contraception (e.g. condom, diaphragm with spermicidal jelly) during the study and for 3 months following the end of their study participation o female patients who are using hormonal contraception must agree to use an additional barrier method (e.g. condom or diaphragm with spermicidal jelly) during the study and for 3 months following the end of study participation o post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. k)Women of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit
    E.4Principal exclusion criteria
    (a)hypersensitivity to sorafenib or any of its excipients (b)cardiac arrhythmias requiring anti-arrhythmics (beta-blockers and digoxin are allowed) (c)symptomatic coronary artery disease or ischemia (d)myocardial infarction (MI) within the last six months; congestive cardiac failure > NYHA Class II (e)active clinically serious bacterial or fungal infections (f)known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C (g)pregnant or breast-feeding (h)patients with uncontrolled hypertension (i)serious uncontrolled concomitant medical or psychiatric illness (j)concomitant medications o which have adverse interactions with sorafenib: rifampicin, ritonavir, ketoconazole, itraconazole and St John’s Wort o treatment with strong CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) which has not been discontinued or switched to a different medication at least 2 weeks prior to starting the study drug. o Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St John’s Wort), which has not been discontinued or switched to a different medication at least 2 weeks prior to starting the study drug. (k)Grade 3 or higher impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome) (l)history of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis (m)history of another primary malignancy that is currently clinically significant or currently requires active intervention. (n)any other clinically significant medical or surgical condition which, according to the CI/PI’s discretion, should preclude participation (o)history of significant congenital or acquired bleeding disorder • patients taking warfarin or cytotoxic drugs
    E.5 End points
    E.5.1Primary end point(s)
    Target inhibition by sorafenib in cutaneous schwannoma biopsies
    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 No
    E.6.5Efficacy No
    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 No
    E.6.13.1Other scope of the trial description
    target inhibition
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 last visit of the last participant to be recruited
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    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: 0
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with a rare disease for which there is currently no drug treatment
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 14
    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)
    As this trial does not test clinical efficacy but molecular activity there will be no continued provision of the drug after this trial. Patients will continue to receive state of the art care. However, if an in vivo molecular effect is demonstrated then a further trial will follow.
    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 Decision2011-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-05
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