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    Summary
    EudraCT Number:2006-006615-80
    Sponsor's Protocol Code Number:matisse1
    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:2007-01-26
    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 number2006-006615-80
    A.3Full title of the trial
    A Pilot Study in Metastatic Advanced Thyroid Cancer
    Evaluating the Safety and Efficacy of Sorafenib
    A.3.2Name or abbreviated title of the trial where available
    MATiSSe
    A.4.1Sponsor's protocol code numbermatisse1
    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 SponsorRoyal Marsden Nhs Foundation 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 healthcare 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/207
    D.3 Description of the IMP
    D.3.1Product nameNexavar
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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 localled advanced or metastatic thyroid cancer . histological sub-types will include differentiated and medullary thyroid cancer.
    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
    The primary endpoint will be the the proportion of patients that have achieved a response during 6 months of treatment with sorafenib tosylate for thyroid cancer.
    E.2.2Secondary objectives of the trial
    Secondary endpoints will be
    - proportion of patients achieving a response during 9 and 12 months of treatment with sorafenib
    - biomarkers
    - toxicity outcomes at 1,3,6,9 and 12 months
    - progression free and overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Human subjects with advanced / metastatic differentiated or medullary thyroid carcinoma
    2. Patients must have one of the following histological sub-types
    - Any papillary subtypes including follicular variants, tall cell, columnar cell and diffuse sclerosing,
    - Any follicular, hurthle cell or medullary
    3. Patients must be deemed not suitable for radio active iodine therapy
    4. Must have uni-dimensional measurable disease on CT or MRI according to Response Evaluation Criteria of Solid tumours (RECIST)
    5. Lesions which are accessible for low risk biopsy
    6. Male/female subjects age 18 years or greater
    7. Patients with ECOG performance status 0, 1 see appendix 3
    8. Life expectancy greater than 12 weeks
    9. The cognitive capacity to understand patient information sheets and give written informed consent and be able to comply with follow up requirements
    10. Women must be post-menopausal (no menstrual period for at least a year) or have a negative pregnancy serum test on entry into the study (even if surgically sterilized)
    Patients must refrain from becoming pregnant throughout their treatment and for upto 6 months after stopping study drug. They must be on adequate contraception (abstinence, oral contraceptives, barrier method with spermicide, implantable or injectable contraceptive or surgical sterilization) throughout this period.

    Patients must have adequate renal, liver and haematological function

    11 Serum creatinine ≤ 1.5 x ULN
    12. Serum aspartate transaminase and alanine transaminase ≤ 2.5 x ULN
    13. Total serum bilirubin ≤ 1.5 x ULN
    14. Amylase and lipase < 1.5 x ULN
    15. Haemoglobin ≥ 9.0g/dl
    16. Absolute neutrophil count ≥ 1.5 x 109 mm3
    17. Platelets ≥ 100 x 109/L
    18. Prothombin time ≤ 1.5 x ULN
    E.4Principal exclusion criteria
    A patient will not be eligible for inclusion in this study if any of the following apply

    1. Anaplastic and poorly differentiated carcinoma of the thyroid
    2. Previous malignancy except cervical cis, Basal cell carcinoma or superficial bladder cancer
    3. Patients with recent or active bleeding diathesis
    4. HIV infection or chronic Hepatitis B or C
    5. Concomitant rifampicin and Hypericum perforatum also known as St. John’s wort
    6. Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity; (see Appendix 5)
    7. Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (see appendix 2) (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic, intervention not indicated, palpitations present and QTc > 0.45-0.47 second).
    8. Patients with active coronary artery disease or ischemia.
    9. Patients with Child-Pugh class C hepatic impairment (see appendix 4)
    10. Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
    11. Patients with uncontrolled hypertension or hypertension treated with 2 or more anti-hypertensive agents
    12. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
    13. Previous treatment with a tyrosine kinase inhbitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab
    14. Any drug (licensed or investigational) that targets the RAS, VEGF, VEGFR or EGFR pathway
    15. Significant surgery within 4 weeks of start of study
    16. Investigational drug therapy during or within 30 days
    17. Any cancer chemotherapy, immunotherapy, radiotherapy or hormonal treatment over the last 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted
    Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanates
    18. Women who are pregnant, breast feeding, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment)
    19. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
    20. Recent thromboembolic events including MI
    21. Need for anti-coagulant therapy (except low dose aspirin)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of the study is the proportion of patients that have achieved a response during 6 months of treatment with the study drug. The best overall response (BOR) for each patient is the best ‘objective overall response’ (ORR) recorded on CRF from the start of treatment until 6 months of treatment with the study drug has been completed. The efficacy variable ORR will be determined on CT/MRI evaluation and biochemical results using the modified RECIST criteria. The proportion of patients that have achieved a response will be the sum of the BOR (only CR, CRu and PR) as a percentage of all patients.
    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 Yes
    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 Information not present in EudraCT
    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 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 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 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
    Data analysis for the primary end-point will be performed 6 months following the date of entry of the thirty third patient into the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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 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 Information not present in EudraCT
    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 state33
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 33
    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)
    Subjects achieving stable disease during the 12 month study period will be allowed to continue the study drug provided the chief investigator considers it beneficial and there is no safety concern. An EOS CRF will be completed 30 days after cessation of the study medication. Subjects will continue with 3 monthly safety assessments and CRF completion while he/she remains on the drug.
    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 Decision2007-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-08-11
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