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    Summary
    EudraCT Number:2015-005246-59
    Sponsor's Protocol Code Number:EO1115
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-005246-59
    A.3Full title of the trial
    Endoscopic electroporation in esophageal cancer
    Endoskopisk elektroporation til behandling af øsofagus tumorer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Electric pulse treatment in esophageal cancer
    Elektrokemoterapi til behandling af tumorer i spiserøret
    A.4.1Sponsor's protocol code numberEO1115
    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 SponsorMichael Patrick Achiam
    B.1.3.4CountryDenmark
    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 supportNovo Nordic Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing support Creganna Tactx Medical
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Surgical Gastroenterology
    B.5.2Functional name of contact pointRigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004520855881
    B.5.6E-mailcharlotte.karin.linnea.egeland@regionh.dk
    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 Bleomycin, "Baxter"
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameBleomycin
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBLEOMYCIN
    D.3.9.1CAS number 11056-06-7
    D.3.9.4EV Substance CodeSUB00842MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number35000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 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
    Esophageal cancer
    Øsofagaus cancer
    E.1.1.1Medical condition in easily understood language
    Esophageal cancer
    Kræft i spiserøret
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    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
    The primary objectives of this phase I trial are to investigate the safety and side effects of treating patients with inoperable GEJ cancer with electroporation delivered through an endoscopic system.
    Formålet med dette projekt er, at undersøge de sikkerhedsmæssige aspekter samt eventelle bivirkninger når man behandler inoperable GEJ-cancer-patienter med endoskopisk elektrokemoterapi.


    E.2.2Secondary objectives of the trial
    The secondary outcome is an evaluation of the response measured by:
    • Positron emission tomography–magnetic resonance imaging (PET-MRI)
    • Dysphagia by Mellow and Pinka’s dysphagia score
    • Patient experience of treatment by Quality of life questionnaires, EORTC QLQ-C30.
    Det sekundære formål med studiet er en evaluering af respons, målet med hjælp af:
    • PET-MR
    • Dysfagi (Mellow and Pinka’s dysphagia score)
    • Livskvalitet spørgeskema, EORTC QLQ-C30
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years old.
    2. Histological verified adenocarcinoma in the gastro-oesophageal junction.
    3. Expected survival > 3 months.
    4. Performance status ECOG/WHO < 2.
    5. Sexually active women who can become pregnant should use adequate contraception during the trial (pill, spiral, injection of prolonged progestin, sub dermal implantation, hormone-containing vaginal devices, transdermal patches).
    6. Platelets ≥ 50 billion/L, International Normalized Ratio (INR) < 1.5. Medical correction is allowed, e.g. correction of a high INR using vitamin K.
    7. Se-creatinine < 150 mole/L, (Cr-51-EDTA-clearance > 40 ml/min) are excluded. (Se-creatinine > 150 mole/L triggers a Cr-51-EDTA-clearence test).
    8. Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
    9. Subjects must give written informed consent.
    10. The patient has a progressing disease, despite previously treatment with palliative chemo/radio therapy
    OR
    11. The patient has a progressing disease, despite previously treatment with palliative radio therapy and he/she can not tolerate palliative systemic chemotherapy treatment.
    E.4Principal exclusion criteria
    1. Coagulation disorder that cannot be corrected.
    2. Subjects with renal dysfunction (Cr-51-EDTA-clearance < 40 ml/min are excluded. If p-creatinine > 150 micromole/L triggers a Cr-51-EDTA-clearence test).
    3. Subjects with a clinically significant cardiac arrhythmia.
    4. Diabetes.
    5. Pregnancy or lactation/breastfeeding.
    6. Concurrent treatment with an investigational medicinal product.
    7. Contraindications for use of bleomycin, including acute pulmonary infection, severe pulmonary disease and allergic reactions to bleomycin observed in previous treatment.
    8. Subjects who have previously undergone a regime of bleomycin with a cumulative dose of > 240.000 units/m2.
    9. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. This includes stenosis that prevents passage of the endoscope.

    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of safety and feasibility of this new method.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All participants will have 3 schedualed follow up appointments.
    7 days: Life of quality questionaries and dysphagia score.
    1 months: Life of quality questionaries and dysphagia score + PET-MRI
    2 months: Life of quality questionaries and dysphagia score + PET-MRI

    All participants will be followed for at least 2 months.
    E.5.2Secondary end point(s)
    Evaluation of tumour regression/reduction in volume measured via PET-MRI.
    Evaluation of the participants subject experience via life of quality questionaries and dysphagia score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PET-MRI at 4 and 8 weeks after initial treatment.
    Evaluation of the participants subject experience via life of quality questionaries and dysphagia score, day 7, week 4, week 8.
    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.8.2.4Number of treatment arms in the trial1
    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 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
    Final follow up on the last participant (number 8) two months after his/her first treatment.
    Afsluttende opfølgning på sidste patient (nummer 8) to måneder efter hans/hendes første behandling.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state8
    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)
    Subjects will return to the standard or care available for esophageal cancer patients.
    Patienterne vil vende tilbage til standard- eller pleje tilgængelig for øsofagus cancer patienter.
    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 Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-06-01
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