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    Summary
    EudraCT Number:2021-006426-43
    Sponsor's Protocol Code Number:IPAX-Linz-01
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-10
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2021-006426-43
    A.3Full title of the trial
    An open label, single arm monocentric phase II study to evaluate safety,
    tolerability, and preliminary efficacy of carrier-added 4-L-
    [131I]iodophenylalanine
    (131I-IPA), administered as sequential injections in patients
    with recurrent IDH1/2 high grade glioma (HGG) concomitantly to 2nd line
    external radiation therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open trial to evaluate safety, tolerability and preliminary efficacy of
    repeated radiotherapy in combination with radioactive iodine therapy in
    patients with relapsed malignant brain tumours
    A.4.1Sponsor's protocol code numberIPAX-Linz-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKepler Universitätsklinikum Linz Neuromed Campus
    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 supportTelix Pharmaceuticals Limited
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKepler Universitätsklinikum Linz Neuromed
    B.5.2Functional name of contact pointDepartment of Neurooncology
    B.5.3 Address:
    B.5.3.1Street AddressWagner Jauregg Weg 15
    B.5.3.2Town/ cityLinz
    B.5.3.3Post code4020
    B.5.3.4CountryAustria
    B.5.6E-mailjosef.pichler@kepleruniklinikum.at
    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/3/06/363
    D.3 Description of the IMP
    D.3.1Product name[131I]-L-4-Iodophenylalanine
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code131 I-IPA
    D.3.9.3Other descriptive name4-IODOPHENYLALANINE I-131
    D.3.9.4EV Substance CodeSUB193819
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2 to 4
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 No
    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
    Previously confirmed histological diagnosis of malignant brain tumours
    (glioma), with current clinical or imaging evidence for first or second
    recurrence
    E.1.1.1Medical condition in easily understood language
    Previously confirmed histological diagnosis of malignant brain tumours
    (glioma), with current clinical or imaging evidence for first or second
    recurrence
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To assess the safety and tolerability of intravenous 131I-IPA
    administered concomitantly to Re- XRT in recurrent HGG
    E.2.2Secondary objectives of the trial
    1. To measure the quality of life before and after therapy
    2. Response assessment using mRANO criteria
    3. Time to Progression, Progression free Survival
    4. Overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previously confirmed histological diagnosis of HGG IDH1/2 wildtype, with current clinical or imaging evidence for first or second recurrence according to modified RANO criteria (2017). History of standard therapy (debulking surgery, followed by radio-chemotherapy (50–60 Gy in 2 Gy fractions, temozolomide). Patients treated with Radiotherapy alone in 1st line according to the elderly GBM protocol could also be included.
    2. Interval since end of 1st line XRT ≥6 months
    3. Amino acid-based molecular imaging (preferably 18F-FET-PET
    indicating pathologically increased amino acid uptake inside or in the
    vicinity of the tumour, clearly discernible from background activity.
    Surgery for relapsed tumour is allowed, if
    postoperative MRI and/or PET shows residual tumour in contrast
    enhanced MRI and/or 18F-FET-PET.
    4.Current indication for repeat radiation therapy as discussed at the
    multidisciplinary neuro-oncological tumour board meeting.
    5. Gross tumour volume (GTV) of up to 5 cm diameter, clinical target
    volume (CTV) 0.5 cm margin and planning target volume (PTV) ≤ 0.5 cm
    margin
    E.4Principal exclusion criteria
    1. Primary XRT dose > 60 Gy
    2. Doses to organs at risk defined by Yasar and Tugrul (2005) exceeded
    or reached by prior radiation therapy; e.g. cumulative total dose on the
    optical chiasm >54 Gy for 2 Gy/fraction, α/β=2
    3. Multifocal distant recurrence, defined as tumour lesion outside the
    primary XRT field, as evidenced by amino acid-based PET imaging or
    CEMRI.
    4. Prior treatment with brachytherapy
    5. Prior treatment with bevacizumab
    6. Localisation of tumour related to brain stem or axis, unless sufficient
    reserve capacity (e.g. remnant resection cavity, marked atrophy) to
    accommodate possible post–procedural tissue reactions, or
    pretherapeutic
    consent for emergency trepanation
    E.5 End points
    E.5.1Primary end point(s)
    safety and tolerability of intravenous 131I-IPA administered
    concomitantly to Re- XRT in recurrent HGG
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the study in scheduled visits up to one year after treatment
    E.5.2Secondary end point(s)
    1. To measure the quality of life before and after therapy
    2. Response assessment using mRANO criteria
    3. Time to Progression, Progression free Survival
    4. Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the study in scheduled visits up to one year after treatment
    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 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 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 No
    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 visit last subject
    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 months6
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 state10
    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)
    post study treatment follows regular care of the disease in the Center
    performing the study
    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 Decision2022-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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