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    Summary
    EudraCT Number:2007-002132-29
    Sponsor's Protocol Code Number:ORH/PID/5336
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-25
    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 number2007-002132-29
    A.3Full title of the trial
    A Phase II Trial of Sorafenib (a tyrosine kinase inhibitor) given orally twice daily in renal cancer patients with vHL syndrome
    A.3.2Name or abbreviated title of the trial where available
    Oral Sorafenib in renal cancer patients with vHL syndrome
    A.4.1Sponsor's protocol code numberORH/PID/5336
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot applicable
    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 SponsorOxford Radcliffe Hospitals 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 PLC
    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 namesorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    von Hippel Lindau syndrome (vHL) is a rare genetic disorder that causes a predisposition to develop multiple tumours, including renal, CNS and retinal tumours. vHL patients who have solid renal tumours (< or =2.4 cm) will require surgery to remove the renal tumours once they reach 2.5cm or greater. Disease-stabilising agents such as sorafenib could potentially delay or avoid the need for surgery.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10047716
    E.1.2Term Von Hippel-Lindau disease
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess stabilisation of disease or response of multiple primary renal cancers.
    E.2.2Secondary objectives of the trial
    To assess the response of other sites of disease including retinal angiomata and spinal cerebellar haemangioma.
    To assess the toxicity profile of Sorafenib in this group of patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible, a patient must meet all of the following criteria:
    1. Proven von Hippel Lindau syndrome by clinical, genetic or histological criteria.
    2. Aged greater than 18 years.
    3. ECOG performance status of 0-2
    4. Lesions will be treated at a size below which surgery would be contemplated in order to prevent progression to larger lesions. Patients must have:
    either a) Multiple renal lesions likely to lead to renal surgery. Lesions must be less than or equal to 2.4cm; OR b) Evidence on serial MRI scans for development of new lesions or progression of existing lesions. Note: other common sites of disease will be assessed by appropriate methodology at baseline (e.g. eyes – fluorescence angiography, Central Nervous System (brain/spinal cord) – MRI).

    5. All patients must be using effective contraception. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment may not be included in the study (this includes men who plan to father a child within 6 months of the last treatment). Women of childbearing potential and all men who are (or become) sexually active must use adequate birth control measures (e.g. oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the study and must continue such precautions for 6 months after receiving the last study agent infusion. All women of child-bearing age (i.e. unless postmenopausal, having had no menstrual period >=1 yr) must have a negative serum or urine pregnancy test performed within 7 days before the start of treatment.
    6. Patient must give written, informed consent.
    7. Haematological and biochemical indices within the following ranges (tests performed within one week before the patient goes on study) : Haemoglobin >or= 9.0 g/dl ; Platelet count > or =100 x 10 to the power of 9/L; Absolute Neutrophil count >or =1.5 x 10 to the power of 9/L; Serum bilirubin < or =1.5 x upper normal limit; Alanine amino-transferase (ALT) < or =2.5 x upper limit of normal (ULN) unless due to tumour in which case up to 5 x ULN is permissible; and Creatinine < or =180 μmol/L
    E.4Principal exclusion criteria
    A patient will not be eligible for the trial if any of the following criteria apply:
    1. Radiotherapy (except for palliative reasons), major surgery, endocrine therapy, immunotherapy, chemotherapy or experimental therapy during four weeks (six weeks for nitrosureas and Mitomycin-C) prior to starting or during trial treatment.
    2. Has had a myocardial infarction in the past twelve months, severe or unstable angina. Patients with a history of atherosclerotic coronary artery disease requiring coronary or peripheral artery bypass surgery may only be enrolled provided the surgery occurred at least two years prior to enrolment and after consultation with a cardiologist to ensure that the disease is stable.
    3. Concurrent congestive heart failure or prior history of class III/ IV cardiac disease (New York Heart Association [NYHA. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted.
    4. Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
    5. Haemorrhage or bleeding event >CTCAE Grade 2 within 4 weeks prior to start of study drug. Taking therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg po qd) is permitted if the INR (International normalized ratio) is <=1.5. Low-dose aspirin permitted (<= 75 mg daily).
    6. Has insulin-dependent diabetes mellitus, or has non-insulin dependent diabetes mellitus with clinical evidence of severe peripheral vascular disease or diabetic ulcers.
    7. High medical risk due to active uncontrolled infection (> grade 2 NCI-CTCAE (National Cancer Institute Common Terminology for adverse Events) version 3.0) or non-malignant systemic disease (> grade 2 NCI-CTCAE version 3.0).
    8. Co-existing or previous other malignancies unless in complete remission for not less than 5 years & excepting in situ carcinoma of the cervix or basal cell skin carcinoma.
    9. History of HIV (Human immunodeficiency virus) infection or chronic hepatitis B or C.
    10. Inability to swallow oral medication.
    11. Known or suspected allergy to sorafenib or its constituents.
    12. Other psychological, social or medical condition or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
    E.5 End points
    E.5.1Primary end point(s)
    To assess stabilisation of disease or response of multiple primary renal lesions.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Information not present in EudraCT
    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 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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    Last Patient Last Visit. Patients should be on study for a minimum of 12 months.
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 25
    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)
    Patients with stable or responding disease at the 12 month assessment point may elect to continue taking sorafenib. If so, they will be seen at 3 monthly intervals until they stop taking sorafenib.
    Once sorafenib is discontinued, subjects will be managed as normal.
    Routine standard of care will be provided as clinically indicated. Currently this involves yearly follow-up assessment at routine, specialist VHL clinics. Clinics will provide the trial with an annual follow-up report.
    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 Decision2007-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-02-15
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