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    Summary
    EudraCT Number:2007-002142-37
    Sponsor's Protocol Code Number:SURGE 01-07
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-002142-37
    A.3Full title of the trial
    SUTENT (SUNITINIB, SU11248) in Patients with Recurrent or Progressive Glioblastoma multiforme
    An Academic Prospective Single-arm Phase II Clinical Trial including Translational Research Studies
    A.3.2Name or abbreviated title of the trial where available
    SUTENT in Patients with Glioblastoma multiforme
    A.4.1Sponsor's protocol code numberSURGE 01-07
    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 SponsorMedizinische Universität Innsbruck
    B.1.3.4CountryAustria
    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 SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameSUTENT
    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.3.8INN - Proposed INNSunitinib
    D.3.9.1CAS number 341031-54-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    Glioblastoma multiforme - WHO grade IV
    First progression/recurrence
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Sunitinib will significantly increase the progression free survival rate at 6 months (PFS6) in patients with recurrent or progressive glioblastoma multiforme from 15% to 35%.

    Primary endpoint: Progression Free Survival at 6 months (PFS6)
    E.2.2Secondary objectives of the trial
    - Overall Survival (OS): Overall Survival at 12 months (OS12)
    - Progression Free Survival (PFS)
    - General Neuroradiological Studies: Objective Radiological Response (RR), Objective Radiological Response Rate (ORR), Objective Radiological Response Duration (ORD)
    - Extended Neuroradiological Studies: Normalization of tumor vessels, visible due to reduction of the tumor blood volume, relative vessel size, vascular permeability, tumor contrast enhancement and tumor edema (combined with a decrease of steroid usage and tumor edema related neurological symptoms)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Patients present with a first recurrence or first progression of a histological confirmed primary supratentorial glioblastoma multiforme WHO Grade IV (Classification following WHO criteria).
    Note: Patients may be entered based on local pathology from the original diagnostic tumor specimen. For Translational Research Studies the original paraffin block - including sufficient tissue of the primary tumor - is required. Stereotactic biopsies or open biopsies of the primary GBM without sufficient tumor tissue are not feasible and the patients must not be enrolled in this study.
    [2] Patients with surgical resection of first tumor progression: Following standard therapy patients must have evidence of first tumor progression. In general, patients may have undergone prior surgical resection of the first tumor progression and will be eligible if the following conditions apply:
     Patients must have recovered from the effects of surgery
     To adequately asses the GBM before surgery and the extent of residual disease postoperatively, two MRIs scans have to be performed:
    The first MRI scan within 2 weeks before surgery to document a progressed or recurrent GBM
    The second MRI scan within 48 hours after surgery
    Note: Patients must be on a steroid dosage that has been stable for at least 5 days before MRI. If the 48-hour scan is performed more than 14 days prior to study enrollment, the scan needs to be repeated (third MRI scan), however, the <48 hour MRI is the baseline scan.
    Patients without surgical resection of first tumor progression: Patients must have evidence of first tumor progression following standard therapy as measured by a baseline MRI within 2 weeks prior to study enrollment (Macdonald criteria: e.g. tumor growth > 25% or new lesion).
    Note: Patients must be on a steroid dosage that has been stable for at least 5 days before MRI. If the steroid dose has increased between the date of imaging and enrollment, a new baseline MRI is required on a stable steroid dosage of at least 5 days duration.
    [3] Resolution of all acute toxic effects of prior therapy to grade ≤ 1 (except alopecia, see Protocol Attachment A.5)
    [4] Patients must have an ECOG performance status of 0-2 (refer to Protocol Attachment A.4)
    [5] Patients must be ≥ 18 years and ≤ 75 years of age, with a life expectancy of greater than 8 weeks
    [6] Patients must have adequate organ function as defined by the following criteria:
    Bone Marrow Reserve - Platelets ≥ 75.000/μL
    - Absolute Neutrophil Count (ANC) ≥ 1500/μL
    - Hemoglobin ≥ 10.0 g/dL
    Blood Coagulation - aPTT ≤ 1.5 times upper limit of normal (ULN)
    Hepatic Function - ASAT and ALAT ≤ 1.5 times ULN
    - ALP ≤ 2.5 times ULN
    - Total Serum Bilirubin < 1 times ULN
    Renal Function - Serum Creatinine ≤ 1.5 times ULN
    Metabolism - Serum Albumin ≥ 3.0 g/dL
    Heart Function - Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by transthoracic echocardiogram (ECHO)
    All tests must be performed ≤ 3 days prior to study enrollment. Eligibility for hemoglobin count may be reached by transfusion
    [7] Signed and dated informed consent document by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment
    [8] Willingness and ability of the patient to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    E.4Principal exclusion criteria
    [9] The patient is active participant in another clinical trial.
    [10] Exclusion of patients in the event of
     surgery for recurrence/progression within 1 week prior to study enrollment
     chemotherapy within 4 weeks prior to study enrollment
     treatment with more than one chemotherapy regime
     radiation therapy within 8 weeks to study enrollment
     evidence in baseline MRI of intratumoral or peritumoral hemorrhage deemed clinically significant by the treating physician (area of hemorrhage > 25% of tumor area)
     custody due to authorization by court or responsible authority.
    [11] Significant Co-Morbidities within 12 months prior to study enrollment
     myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure
     pulmonary embolus
     cerebro-vascular accident including TIA (transient ischemic attack)
    [12] Significant Co-Morbidities at Baseline Evaluation
     Clinically significant ongoing cardiac dysrhythmias of grade ≥ 2, atrial fibrillation of any grade, QTc interval > 470 ms measured by electrocardiogram (ECG)
     Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
     A known HIV (human immunodeficiency virus) or Hepatitis B/C infection or severe acute infection
    [13] Anticoagulation: Current treatment with therapeutic doses of Marcoumar / Sintrom excluding thrombosis prophylaxis with low dose Heparin.
    [14] Antiepileptic Drugs: Concurrent use of EIADs within 2 weeks of study enrollment (patients must discontinue EIAD treatment ≥ 14 days prior to study enrollment, refer to Section 4.2.2.2 and Protocol Attachment A.9)
    [15] Pregnancy, Breastfeeding and Non-Contraception
     Female patients who are pregnant or nursing
     Patients who are sexually active and unwilling or unable to use a medically acceptable method of contraception during the trial.
    Note: Female and male patients with reproductive potential have to use an approved contraceptive method (e.g., hormonal contraception, intrauterine device, condom with spermicide, etc.) during and for 3 months after discontinuation of study treatment. Female Patients with child-bearing age must have a negative serum pregnancy test ≤ 3 days prior to study enrollment. During study treatment pregnancy has to be excluded (serum pregnancy tests every 2 weeks until tumor progression).
    [16] Evidence of increased intracranial pressure
     midline shift > 5 mm
     distinct nausea and vomiting
    [17] Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart excess risk associated with study participation or study drug administration, or which would make the patient inappropriate for entry into this study. The decision to enroll the patient in this study is in the judgment of the investigator.
    [18] Hypersensitivity to sunitinibmalate or any other ingredients of SUTENT
    E.5 End points
    E.5.1Primary end point(s)
     Progression-free survival rate at 6 months (PFS6)
    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 No
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    The end of study is reached, when all patients have completed the planned observations including the post progression follow-up period, i.e. when the last enrolled patient has completed the sixth post-progression follow-up contact. Due to a possible 18 months recruitment phase and a period of about months of Sunitinib treatment until end of treatment (EOT), the entire study period will last about 2 years.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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 Decision2008-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-01
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