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    Summary
    EudraCT Number:2007-004669-17
    Sponsor's Protocol Code Number:CSTI571E2205
    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:2007-10-16
    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 number2007-004669-17
    A.3Full title of the trial
    A multi-center, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis
    A.4.1Sponsor's protocol code numberCSTI571E2205
    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 SponsorNovartis Pharma Services AG
    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 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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    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 nameGlivec
    D.3.2Product code STI571
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNimatinib
    D.3.9.1CAS number 220127-57-1
    D.3.9.2Current sponsor codeSTI571
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Skin fibrosis in systemic sclerosis patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    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 the efficacy of oral STI571 in skin fibrosis in systemic sclerosis (SSc) patients as measured by an improvement in the modified Rodnan Skin Score.
    •To assess the safety and tolerability of oral STI571 in SSc patients.
    E.2.2Secondary objectives of the trial
    Secondary objectives
    •To assess improvement in lung functions as measured by CO diffusion capacity (DLCO) and Forced Vital Capacity (FVC).
    •To assess biomarkers reflecting the direct effects of STI571 on its biological targets.
    •To determine the PK trough levels of STI571 and its major active metabolite CGP74588 during dose escalation and the maintenance phase of the study.
    Exploratory objective
    •To explore alternative biomarkers that may provide additional measures of efficacy of STI571 in skin, plasma/serum and urine samples.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female patients equal to or older than 18 years of age and fulfilling the American College of Rheumatology criteria for systemic sclerosis (SSc)
    •Diffuse cutaneous SSc (dcSSc) according to the LeRoy criteria with disease duration less than 18 months from the appearance of the first non-Raynaud´s symptom judged by a physician to be part of SSc
    •Patients with a modified Rodnan Skin Score of at least 20 (maximum score 51) in the absence of trunk involvement or a modified Rodnan Skin Score of at least 16 in patients with trunk involvement
    •Female patients of child bearing potential must be using two acceptable methods of contraception (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through Study Completion.
    Period abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    •Male patients must be using a two acceptable methods of contraception, (e.g., spermicidal gel plus condom) for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the three (3) months following last study drug administration.
    Periodic abstinence and withdrawal are not acceptable methods of contraception.
    •Able to communicate well with the Investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1.Concurrent connective tissue diseases other than SSc including SSc-like illnesses related to environmental, ingested or injected agents, and also including overlap syndromes and mixed connective tissue disease.
    2.Significant pre-existing internal organ damage:
    •kidneys:
    •MDRD calculated creatinine clearance < 40 mL/min
    •renal crisis (acute onset of renal failure, moderate to marked hypertension, and normal urine sediment with mild proteinuria) in the 2 months prior to treatment
    •lungs:
    •FVC < 50% predicted
    •CO diffusion capacity < 40% predicted
    •heart:
    •left ventricular ejection fraction < 40%
    •ECG conduction abnormalities deemed by the Investigator to be clinically significant (including atrio-ventricular blocks, atrial or ventricular arrhythmias, sinus pauses > 3 seconds)
    •gut:
    •pseudo-obstruction
    •mal-absorption requiring parental nutrition.
    3.Existing myositis: serum creatine phosphokinase > 3 fold of the upper-limit
    4.Conditions that might mimic potential side effects of STI571:
    •hematological conditions: - thrombocytopenia < 100 x 109/L
    •neutropenia < 1.5 x 109/L
    •moderate hepatic insufficiency with transaminase levels >3 fold the upper limit of normal, or bilirubin > 2 fold the upper limit of normal
    •chronic diarrhea for more than 4 weeks
    •peripheral edemas
    5.Concurrent interventional medical therapy that might potentially influence the outcome of the disease. Treatment with other potentially disease modifying agents during the last 6 weeks, including prednisone or corticosteroid equivalent in doses higher than 15 mg/d or changes in the prednisone doses during the last 1 month before first dosing.
    6.Grapefruit juice should not be drunk whilst patients participate in the study. Special attention should be given to the co-prescription of CYP3A4 inhibitors (e.g. Amiodarone, Diltiazem, Verapamil, macrolide antibiotics, Itraconazole and Ketoconazole), and to some of the drugs metabolized by CYP450 isoenzymes (Phenytoin, Carbamazepin, Rifampicin, Phenobarbital, Saint-John’s Wort, Cyclosporine, Warfarin or Paracetamol). For guidance on drug-drug interactions see Section 6.5.3 on concomitant medication.
    7.Other conditions that might be associated with an increased risk to the patient or interfere with successful conduction of the trial:
    •underlying chronic debilitating diseases such as cancer,
    •pregnancy, breast feeding or lack of safe contraception (IUD, diaphragm, bilateral tubal ligation, hysterectomy) in women of childbearing potential.
    8.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient in case of participation in the study. The Investigator should be guided by evidence of any of the following:
    •history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
    •history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
    •history or clinical evidence of pancreatic injury or pancreatitis.
    9.Participation in any treatment studies within 3 months prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    10.Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
    11.History of acute or chronic bronchospastic disease (at the discretion of Investigators)
    12.History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
    13.History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
    14.A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    15.History of drug abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations at the discretion of the investigator.
    16.Chronic thromboembolic pulmonary hypertension.
    17.Severe systemic arterial hypertension (>180 mm Hg [systolic] or >110 mm Hg [diastolic])
    18.Congenital or acquired valvular or myocardial disease.
    19.A past medical history of clinically significant ECG abnormalities.
    20.History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia).
    21.History of myocardial ischemia or infarction.
    22.History of heart failure.
    23.Disseminated intravascular coagulation (DIC).
    24.Sickle cell anemia or other anemia associated with hemoglobin < 10 mg/dL.
    25.Evidence of major bleeding or intracranial hemorrhage in the last two years.
    26.Ischemic stroke in the last two years.
    27.History of other significant illness within four weeks prior dosing.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline in MRSS at time point t is calculated for each patient as
    % change form baseline(t)=[mRSS(t)-mRSS(baseline)] / mRSS(baseline)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Biomarker
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    As defined in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 27
    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 in protocol
    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 Decision2007-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-13
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