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    Summary
    EudraCT Number:2011-004189-13
    Sponsor's Protocol Code Number:1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-25
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-004189-13
    A.3Full title of the trial
    ASSESSMENT OF MULTIDRUG RESISTANCE IN BREAST CANCER AND LOW GRADE GLIOMA PATIENTS WITH [11C]TARIQUIDAR PET. A PILOT STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASSESSMENT OF MULTIDRUG RESISTANCE IN BREAST CANCER AND LOW GRADE GLIOMA PATIENTS WITH [11C]TARIQUIDAR PET. A PILOT STUDY
    A.3.2Name or abbreviated title of the trial where available
    11C_TQD_ONKO
    A.4.1Sponsor's protocol code number1
    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 SponsorMedizinische Universität Wien
    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 supportFWF
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität wien
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressWähringer-Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404002981
    B.5.5Fax number00431404002998
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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.2.1.1.1Trade name N/A
    D.2.1.1.2Name of the Marketing Authorisation holderN/A
    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 name11C-tariquidar
    D.3.2Product code 11C-tari
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN11C-tariquidar
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number360 to 400
    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
    Prospective cohort diagnostic test accuracy study in 30 breast cancer patients scheduled for neoadjuvant chemotherapy (15 of which with Pgp-positive and 15 with Pgp-negative tumors) and 10 low grade glioma patients (group G) scheduled for surgical tumor removal.
    E.1.1.1Medical condition in easily understood language
    breast cancer patients scheduled for neoadjuvant chemotherapy and low grade glioma patients (group G) scheduled for surgical tumor removal.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10006153
    E.1.2Term Brain tumor
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10006192
    E.1.2Term Breast cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
     To correlate PET imaging outcome parameters (e.g. volume of distribution (VT) of [11C]tariquidar in tumor tissue) at staging with Pgp expression levels measured by IHC and/or at baseline (diagnostic biopsy)
    E.2.2Secondary objectives of the trial
     To correlate [11C]tariquidar PET imaging outcome parameters and Pgp expression levels at baseline with response to neoadjuvant chemotherapy measured by Response Evaluation Criteria In Solid Tumors (RECIST)
     Assess safety and tolerability of [11C]tariquidar PET imaging
     To correlate changes in [11C]tariquidar PET imaging outcome parameters with changes in Pgp expression levels before and after chemotherapy (optional)
     To correlate [11C]tariquidar PET imaging outcome parameters and Pgp expression levels measured after chemotherapy with response to neoadjuvant chemotherapy measured by RECIST criteria (optional)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Sex: female (only group B), male and female (group G)
    • Age: >18years old
    • Breast cancer patients scheduled for neoadjuvant chemotherapy (group B) or low grade glioma patients (group G) scheduled for surgical tumor removal.
    • Histologically confirmed breast cancer with estimated lesion size of >2 cm (gor group B only)
    • Availability of tumor biopsy at the time of diagnosis for IHC and/or WB analysis
    • Volunteers must sign the informed consent prior to inclusion in the study
    • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
    E.4Principal exclusion criteria
    Any abnormality found as part of the pretreatment screening or in any of the laboratory tests performed that the investigators considers might influence the outcome of the study (e.g. co-morbidities)
    • Participation in a clinical study with a radioactive substance in the last 12 months
    • Intake of any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study, due to interference with CYP3A4 and/or Pgp
    • For female subjects in child-bearing age: Pregnancy or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
     Correlation of [11C]tariquidar PET imaging outcome parameters at staging with Pgp expression levels measured by IHC at baseline (diagnostic biopsy)
    E.5.1.1Timepoint(s) of evaluation of this end point
    after first PET scan
    E.5.2Secondary end point(s)
     Correlation of [11C]tariquidar PET imaging outcome parameters and Pgp expression levels at baseline with response to neoadjuvant chemotherapy measured by RECIST criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
     after end of neoadjuvant chemotherapy (expected duration: 3 weeks)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 Yes
    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 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
     Failure to observe the study conditions or instructions from the study team
     Failure to comply with any aspect to the protocol
     Detection of drugs or addictive substances
     Occurrence of AEs or inter-current diseases which the investigator deems to be unacceptable
    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 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.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state30
    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)
    Patients will receive treatment according to their needs at the Department of Oncology at the Medical University of Vienna after completion of 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 Decision2012-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-31
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