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    Summary
    EudraCT Number:2019-002947-41
    Sponsor's Protocol Code Number:N19PCA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-002947-41
    A.3Full title of the trial
    Neoadjuvant trial on the efficacy of propranolol monotherapy in angiosarcoma (PROPANGIO).
    Neo-adjuvante "window of opportunity" studie naar de effectiviteit van propranolol monotherapie in patiënten met angiosarcoom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Propranolol as treatment of patients with angiosarcoma before their standard therapy.
    Propranolol als behandeling van patiënten met angiosarcoom voorafgaand aan hun standaard behandeling.
    A.3.2Name or abbreviated title of the trial where available
    propranolol in angiosarcoma
    propranolol in angiosarcoom
    A.4.1Sponsor's protocol code numberN19PCA
    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 SponsorNetherlands Cancer Institute- Antoni van Leeuwenhoek
    B.1.3.4CountryNetherlands
    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 supportNetherlands Cancer Institute
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute- Antoni van Leeuwenhoek
    B.5.2Functional name of contact pointN. Steeghs
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.6E-mailn.steeghs@nki.nl
    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 propranolol
    D.2.1.1.2Name of the Marketing Authorisation holderpropranolol HCI TEVA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberNo 141/2000
    D.3 Description of the IMP
    D.3.1Product namepropranolol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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
    Angiosarcoma
    angiosarcoom
    E.1.1.1Medical condition in easily understood language
    cancer arising from the inner layer of the blood or lymphatic vessels
    kanker dat uit de binnenste laag van de bloed- of lymfevaten ontstaat
    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 determine the clinical response of propranolol monotherapy in patients with angiosarcoma.
    om de klinische respons op propranolol monotherapie bij patiënten met angiosarcoom te onderzoeken
    E.2.2Secondary objectives of the trial
    To determine the histologic response of propranolol monotherapy in patients with angiosarcoma.
    om de histologische respons op propranolol monotherapie bij patiënten met angiosarcoom te onderzoeken
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Histological proof of angiosarcoma
    o Patients with primary, recurrent and metastasised disease are eligible;
    o Age of 18 years or more;
    o Able and willing to give written informed consent;
    o WHO performance status of 0, 1 or 2;
    o Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma
    o Patients with a window of at least 3 weeks before surgery or systemic therapy;
    o At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician.
    o Histologisch bewezen angiosarcoom
    o Patiënten met primair, gerecidiveerd of gemetastaseerd angiosarcoom
    o Leeftijd van 18 jaar of meer;
    o Wilsbekwaam om geschreven informed consent te geven;
    o WHO performance status van 0, 1 of 2;
    o Evalueerbare ziekte volgens RECIST 1.1 criteria; ziekte hoeft niet radiologisch zichtbaar te zijn in patiënten met cutaan angiosarcoom
    o Patiënten met een periode van minimaal 3 weken voor de start van de standaardbehandeling
    o Minimaal 1 tumorlaesie toegankelijk voor veilig biopteren, baserend op oordeel van behandelende arts
    E.4Principal exclusion criteria
    o Contraindication for propranolol therapy,
    o Current treatment with β-blockade therapy.
    o Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
    o Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
    opregnancy
    o Contra-indicaties voor behandeling met propranolol
    o Patiënten die al behandeld worden met β-blokkade
    o Een andere anti-kanker behandeling binnen 30 dagen voor start met de studiebehandeling, hormoontherapie voor borstkanker is wel toegestaan
    o Gelijktijdige behandeling met een andere anti-kanker behandeling, hormoontherapie voor borstkanker is wel toegestaan
    o Zwangerschap
    E.5 End points
    E.5.1Primary end point(s)
    The clinical response will be determined in terms of decrease in tumor size on examination, according to RECIST criteria (PR is >30% decrease in size, PD is >20% increase in size, SD is in between while CR is no measurable disease). In patients with cutaneous angiosarcoma, documentation will be performed with color photography, including a ruler to estimate the size of the lesion. Otherwise radiologic assessments will be used to evaluate anti-tumor activity.
    If propranolol leads to a response in ≥3 out of 14 patients, this treatment modality is highly interesting and should be tested further in a randomized trial. A response is defined as CR, PR, or SD with an improvement in clinical characteristics, like thickness, erythema, necrosis or edema of the inflicted area in case of clinically evaluable disease (cutaneous angiosarcoma).
    De klinische respons wordt gemeten aan de hand van de beoordeling van de tumorgrootte middels RECIST criteria (PR is >30% afname in grootte, PD is >20% toename in grootte, SD is verandering hiertussen in en CR is wanneer er geen meetbare ziekte meer is).
    Bij patiënten met een cutaan angiosarcoom zal beoordeling van de tumorlaesie middels een kleurenfoto inclusief meetlint geschieden.
    Als ≥3 van de 14 patiënten een respons laten zien op de studiebehandeling, dan beschouwen we propranolol als interessant om verder onderzocht te worden in een gerandomiseerde studie. Een respons is gedefinieerd als CR of PR, of SD met een verbetering van klinische kenmerken zoals dikte, erytheem, necrose of oedeem van de tumor als de laesie klinisch te evalueren is (cutaan angiosarcoom).
    E.5.1.1Timepoint(s) of evaluation of this end point
    weekly evaluation on the outpatient clinic
    evaluatie zal wekelijks op de poli plaatsvinden
    E.5.2Secondary end point(s)
    The histologic response on propranolol treatment in terms of difference in proliferation index by immunohistochemistry staining of Ki-67 and in tumor activity will be determined between the post-treatment biopsy (obtained during surgery if applicable) and the diagnostic biopsy. A decrease of >30% of Ki-67 staining was stated as a positive histologic response.
    De histologische respons op propranolol zal worden bepaald aan de hand van het verschil in de proliferatie index (immunohistochemische kleuring op Ki-67) en de tumoractiviteit tussen het pre- en postbehandelingsbiopt. Bij een afname van >30% in de Ki-67 kleuring is er sprake van een positieve pathologische respons.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The pretreatment biopsy, obtained during screening, will be compared with the biopsy after the study treatment (after 3-6 weeks of propranolol).
    Het prebehandelingsbiopt dat tijdens de screening wordt afgenomen zal worden vergeleken met het postbehandelingsbiopt (na 3-6 weken behandeling met propranolol).
    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 No
    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 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 Yes
    E.8.2.3.1Comparator description
    er is geen andere behandeling waarmee propranolol zal worden vergeleken
    there will be no comparator
    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
    the study will be closed after the last patient finishes his/hers study treatment
    de studie zal worden gesloten nadat de laatste patiënt zijn/haar studiebehandeling heeft afgerond.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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.1.2.1Number of subjects for this age range: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state14
    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)
    Study treatment can be continued after the study has been closed.
    Patiënten mogen worden doorbehandeld met de studiemedicatie nadat de studie is afgerond.
    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 Decision2019-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-13
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