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    Summary
    EudraCT Number:2014-002741-21
    Sponsor's Protocol Code Number:AAA-Ga-TOC-EU-01
    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:2014-09-03
    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 number2014-002741-21
    A.3Full title of the trial
    Safety and tolerability of 68Ga-DOTATOC for injection in patients with proven gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and tolerability of an injectable diagnostic radiopharmaceutical (68Ga-DOTATOC) in patients with proven gastro-entero-pancreatic neuroendocrine tumors.
    A.3.2Name or abbreviated title of the trial where available
    68Ga-DOTATOC in patients with GEP-NETs
    A.4.1Sponsor's protocol code numberAAA-Ga-TOC-EU-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 SponsorAdvanced Accelerator Applications SA
    B.1.3.4CountryFrance
    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 supportAdvanced Accelerator Applications SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdvanced Accelerator Applications
    B.5.2Functional name of contact pointClementina Brambati
    B.5.3 Address:
    B.5.3.1Street AddressAdvanced Accelerator Applications
    B.5.3.2Town/ cityVia Ribes, 5
    B.5.3.3Post code10010
    B.5.4Telephone number+390125561231
    B.5.5Fax number+390125561202
    B.5.6E-mailclementina.brambati@adacap.com
    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 nameKit for the preparation of 68Ga-DOTATOC for injection
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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.3.8INN - Proposed INNDOTA0-Tyr3-Octreotide
    D.3.9.1CAS number 204318-14-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number36 to 44
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with proven gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
    E.1.1.1Medical condition in easily understood language
    Patients suffering from a specific type of malignant tumours of the gastrointestinal tract named GEP-NETs.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10062476
    E.1.2Term Neuroendocrine tumor
    E.1.2System Organ Class 100000004864
    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 a single administration of 2 MBq/kg - but not less than 100 MBq - of 68Ga-DOTATOC in patients suffering from gastro-entero-pancreatic neuroendocrine tumours.
    E.2.2Secondary objectives of the trial
    No secondary objective
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients with confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) where increased expression of somatostatin receptors is the diagnosis target in case of disease characterization, staging or restaging.
    •Biopsy proven Grade I or II GEP-NET, as per WHO classification, confirmed by histology/ immuno-histochemistry.
    •Staging assessed by CT/MRI within 3 months prior to enrolment.
    •Age ≥ 18 year old.
    •ECOG Performance Status ≤ 2.
    •Females of childbearing potential must have a negative pregnancy test at screening/baseline.
    •Absence of clinically significant ECG abnormalities.
    •Ability to understand and sign an informed consent form.
    E.4Principal exclusion criteria
    •Any patient receiving a treatment with short-acting Octreotide which cannot be interrupted for 24 h before administration of 68Ga-DOTATOC, or any patient receiving a treatment with long-acting SSA which cannot be interrupted for at least 4 weeks before the administration {i.e. 68Ga-DOTATOC administration should not be performed earlier than 4 weeks (+/- 3) days after the last administration of long-lasting SSA}.
    •Pregnancy or lactation.
    •Known hypersensitivity to the investigational drug or any of its components.
    •Patients who have not provided a signed informed consent form to participate in the study, prior to the start of any protocol related activities.
    •Patients who, within the last 30 days, have participated in any clinical study of a therapeutic agent which may interfere with the safety or efficacy analysis of the investigational product.
    •Any other disease conditions, such as inflammatory or granulomatous diseases, or abnormal physical finding that may interfere with the study objective as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is safety and tolerability of a single administration of 68Ga-DOTATOC, assessed by adverse events, physical examination, vital signs, ECG, haematology, biochemistry, and urine tests performed at different time points before and after the study product administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be recorded during the whole study period. Haematology, biochemistry, urine tests will be monitored before and after 68Ga-DOTATOC injection (at screening, Day 0, Day 7 and Day 28). Vital signs will be recorded at each study visit. Physical examination will be performed at screening, Day 0 (at least one hour after administration), Day 7 and Day 28. ECG will be monitored at screening and after the administration (Day 0).
    E.5.2Secondary end point(s)
    No secondary endpoint are planned in this study
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 a subject has ended his/her participation in the trial, no specific treatment or follow-up will apply except normal treatment his/her medical condition requires. Because the study medicine indication is a single injection for a specific diagnostic exam, there is no reason to plan any arrangement for continued provision of the intervention for participants once the research has finished.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-01
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