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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-001860-27
    Sponsor's Protocol Code Number:A6181036
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-11
    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 ConcernedGreece - EOF
    A.2EudraCT number2004-001860-27
    A.3Full title of the trial
    A TREATMENT PROTOCOL FOR PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS AND ARE REFRACTORY TO OR INTOLERANT OF IMATINIB MESYLATE
    A.4.1Sponsor's protocol code numberA6181036
    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 SponsorPfizer Hellas A.E.
    B.1.3.4CountryGreece
    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 No
    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/3/05/267
    D.3 Description of the IMP
    D.3.2Product code SU011248 L-Malate Salt
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12,5 to 50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Patients with Gastrointestinal Stromal Tumor who are Refractory to Standard Therapy and May Derive Benefit for Treatment with SU011248
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLY
    E.1.2Classification code 10062427
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to provide access to SU011248 treatment for patients with GIST given the following conditions:
    a) patients who undergo screening, but are ineligible for participation in ongoing SU011248 clinical studies (such as A6181004), and
    b) patients have received treatment with imatinib mesylate and have developed resistance or intolerance, and
    c) patients have, in the judgment of the investigator, the potential to derive clinical benefit from treatment with SU011248.
    E.2.2Secondary objectives of the trial
    The following clinical endpoints will be evaluated:
    - Safety profile of SU011248
    - Overall survival (OS)
    - Time-to-progression (TTP)
    - Objective response rate (ORR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histopathologically proven diagnosis of malignant GIST that is not amenable to
    standard therapy with curative intent.
    2. Must have undergone screening and found to be ineligible for participation in
    ongoing SU011248 clinical studies such as the A6181004 Phase 3 trial.
    3. Judged to have the potential to derive clinical benefit from SU011248 treatment
    by the treating physician.
    4. Failed prior treatment with imatinib mesylate, defined either by progression of
    disease, or by significant toxicity during treatment with imatinib mesylate that
    precluded further treatment. Intolerance to prior imatinib mesylate therapy will
    be defined as follows:
    - Life-threatening adverse events (ie, Grade 4 according to NCI CTCAE Version
    3.0) at any dose (attempt to dose reduce or rechallenge not required) or
    - Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day).
    Specifically, major/equal to Grade 2 toxicity that is unacceptable to the patient
    (such as nausea) that persists despite standard countermeasures
    5. Male or female, 18 years of age or older.
    6. Resolution of all acute toxic effects of prior systemic therapy (including imatinib
    mesylate), radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade
    minor/equal to 1.
    7. Adequate organ function as defined by the following criteria:
    - Total serum bilirubin minor/equal to 2 x ULN (patients with Gilbert’s disease
    exempt)
    - Serum transaminases <5 x ULN
    - Absolute neutrophil count (ANC): major/equal to 1000/mL
    - Platelets: major/equal75,000/mL
    - Hemoglobin major/equal 8.0 g/dL
    8. Signed and dated informed consent document indicating that the patient (or
    legally acceptable representative) has been informed of all the pertinent aspects
    of the trial prior to enrollment.
    9. Willingness and ability to comply with scheduled visits, treatment plans and
    laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Current treatment in another clinical trial
    2. Symptomatic CNS metastases
    3. Symptomatic congestive heart failure, myocardial infarction or coronary artery
    bypass graft in the previous six months, ongoing severe or unstable angina or
    any unstable arrhythmia requiring medication
    4. Pregnancy or breastfeeding (see Section 4.4 for further details)
    5. Other severe acute or chronic medical or psychiatric condition, or laboratory
    abnormality that would impart, in the judgment of the investigator, excess risk
    associated with study participation or study drug administration, or which, in the
    judgment of the investigator, would make the patient inappropriate for entry into this study
    E.5 End points
    E.5.1Primary end point(s)
    This is an open-label “treatment use” protocol for patients with GIST given the following conditions: a) patients undergo screening, but are ineligible, for participation in ongoing clinical studies such as A6181004, AND b) patients have GIST which standard treatments have not been able to control with acceptable tolerability, AND c) patients have, in the judgment of the investigator, the potential to derive clinical benefit from treatment with SU011248.
    Disease assessments for tumor response and progression will be done as per standard of care for GIST. Minimal disease evaluation data (best response and date of progression) will be collected within this protocol.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Patients may continue to access SU011248 on this protocol as long as there is evidence of disease control in the judgment of the investigator.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 500
    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)
    The Subject will continue to have access to SU011248 after the end of the trial as long as there is evidence of disease control in the judgment of the investigator.
    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 Decision2006-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
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