Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-002211-11
    Sponsor's Protocol Code Number:MIP-IB12
    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:2007-10-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-002211-11
    A.3Full title of the trial
    A PHASE I-II STUDY EVALUATING THE MAXIMUM TOLERATED DOSE,
    DOSIMETRY, SAFETY, AND EFFICACY OF ULTRATRACE™ IOBENGUANE I 131 IN
    PATIENTS WITH MALIGNANT PHEOCHROMOCYTOMA/PARAGANGLIOMA
    A.4.1Sponsor's protocol code numberMIP-IB12
    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 SponsorMolecular Insight Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzedra™ Ultratrace™ Iobenguane I 131
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIobenguane I 131
    D.3.9.1CAS number 80663-95-2
    D.3.9.3Other descriptive nameUltratrace™
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/ml millicurie(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number13.5 to 16.5
    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 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 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.IMP: 2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzedra™ Ultratrace™ Iobenguane I 131
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIobenguane I 131
    D.3.9.1CAS number 80663-95-2
    D.3.9.3Other descriptive nameUltratrace™
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/ml millicurie(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number13.5 to 16.5
    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 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 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
    MALIGNANT PHEOCHROMOCYTOMA/PARAGANGLIOMA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10034876
    E.1.2Term Pheochromocytoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I
    • To determine the maximum tolerated dose (MTD) of Ultratrace iobenguane I 131 in
    patients with malignant pheochromocytoma/paraganglioma

    Phase II
    • To determine the objective tumor response rate and its 95% confidence interval at 9 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma
    E.2.2Secondary objectives of the trial
    Phase I
    • Estimate radiation absorbed doses to target lesions and to a standard set of normal organs following a 5.0 mCi tracer infusion of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma
    • Assess objective tumor response at 3, 6, 9 & 12 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma

    Phase II
    • Assess the objective tumor response rate and its 95% confidence interval at 3, 6, and 12 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma
    • Determine the biochemical response rate and its 95% confidence interval at 3, 6, 9, and 12 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma

    Only the first two secondary objectives are listed for each phase of the study. For the full list please refer to the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have a diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma by:
    o histological confirmation –OR--
    o plasma-free metanephrines and 24-hour urine test for catecholamines/metanephrines
    • Disease is metastatic or has recurred following surgery
    • At least one measurable lesion seen by computed tomography (CT) or magnetic resonance (MR) scan performed with IV contrast within 4 weeks prior to the first dose of study drug
    • At least one measurable tumor site is also seen on Ultratrace iobenguane I 131 scan
    • Provide written informed consent and are willing to comply with protocol requirements
    • Are at least 18 years of age
    • If female, then not of childbearing potential as documented by history (e.g., tubal ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses
    • If female of childbearing potential, has a negative serum βHCG pregnancy test within 48 hours prior to receiving iobenguane I 131
    • Females who agree not to become pregnant and males who agree not to father a child during the 1 year period following the therapeutic dose of Ultratrace iobenguane I 131. Both females and males must use an acceptable method of birth control during the first year following the therapeutic dose of Ultratrace iobenguane I 131.
    E.4Principal exclusion criteria
    • Females who are nursing
    • Active CNS lesions by CT/MR scanning within 3 months of study entry
    • New York Heart Association class III-IV heart failure
    • Received any previous systemic radiotherapy within 6 months of study entry [prior carrier-added iobenguane I 131 therapy is allowed if not within 6 months]
    • Administered prior whole-body radiation therapy
    • Received external beam radiotherapy to > 25% of bone marrow
    • Administered prior chemotherapy within 30 days of study entry
    • Karnofsky performance status is < 60
    • Platelets ≤ 100,000/μL
    • Absolute neutrophil count (ANC) ≤ 1,500/μL
    • Serum creatinine ≥ 1.5 mg/dL
    • Total bilirubin ≥ 1.5 times the upper limit of normal
    • AST/SGOT or ALT/SGPT ≥ 2.5 times the upper limit of normal
    • Has a known allergy to iobenguane, iodine, or SSKI that has required medical intervention
    • Has received a therapeutic investigational compound and/or medical device within 30 days before admission into this study
    • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
    • Has evidence of altered biodistribution of Ultratrace iobenguane I 131
    • Has evidence of renal obstruction
    • Is determined by the Investigator that the patient is clinically unsuitable for the study.
    • Has received a medication which inhibits uptake of iobenguane I 131:
    - phenothiazines or decongestants within 2 weeks prior to the first dose of Ultratrace iobenguane
    I 131;
    - a tricyclic antidepressant within 6 weeks prior to the first dose of Ultratrace iobenguane I 131;
    or,
    - labetelol within 1 week prior to the first dose of Ultratrace iobenguane I 131.
    E.5 End points
    E.5.1Primary end point(s)
    Dosimetry [phase I only]
    - radiation absorbed doses to target lesions and to normal organs in accordance with MIRD
    Efficacy:
    - objective tumor response per Response Evaluation Criteria in Solid Tumors (RECIST)
    - dose-response [phase I only]
    - biochemical response
    Safety:
    - maximum tolerated dose [phase I only]
    - treatment emergent AEs
    - clinical laboratory measurements
    - vital signs measurements
    - ECG measurements
    - physical examination findings
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding, Safety & efficacy
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.2.3.1Comparator description
    None
    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 EEA14
    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 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
    Patients will be monitored from the time of signed informed consent through 12 months after the second (therapeutic) Ultratrace iobenguane I 131 infusion. Patients then enter long-term follow-up until 5 years posttreatment or death, to obtain objective response, biochemical response, overall survival, serious adverse events, and late radiation toxicity.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 62
    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)
    After pariticpation in the study, patients will receive treatment according to the local institutions appropriate standard of care
    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 Decision2007-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-02-07
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 20 01:03:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA