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    Summary
    EudraCT Number:2022-002311-39
    Sponsor's Protocol Code Number:101069207
    National Competent Authority:Cyprus - MoH-Ph.S
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-09
    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 ConcernedCyprus - MoH-Ph.S
    A.2EudraCT number2022-002311-39
    A.3Full title of the trial
    Phase II trial for the use of ketotifen to enhance therapy in patients with sarcoma receiving standard chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Ketotifen to enhance treatment efficacy in patients with sarcoma
    A.3.2Name or abbreviated title of the trial where available
    DL-MechanoPredictor
    A.4.1Sponsor's protocol code number101069207
    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 SponsorUniversity Of Cyprus
    B.1.3.4CountryCyprus
    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 supportEuropean Research Council Executive Agency (ERCEA)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Cyprus
    B.5.2Functional name of contact pointMME Department (Dr. Stylianopoulos)
    B.5.3 Address:
    B.5.3.1Street Address1 Panepistimiou Ave
    B.5.3.2Town/ cityAglantzia
    B.5.3.3Post code2109
    B.5.3.4CountryCyprus
    B.5.4Telephone number35722892248
    B.5.6E-mailmarkou.maria@ucy.ac.cy
    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 Zaditen
    D.2.1.1.2Name of the Marketing Authorisation holderAlfasigma S.p.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    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
    Patients with sarcoma
    E.1.1.1Medical condition in easily understood language
    Patients that suffer from a type of cancer, known as sarcoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This trial’s objective is to demonstrate that the use of ketotifen can improve the efficacy of chemotherapy in patients with sarcoma.
    E.2.2Secondary objectives of the trial
    A secondary objective of this trial is to demonstrate that measuring and monitoring tumor stiffness using non-invasive, clinically applied ultrasound shear wave elastography can be used as a predictive biomarker.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria include:
    • patients aged 18 and over,
    • with a biopsy proven sarcoma subtype,
    • a performance status (PS) 0 or 1 (ECOG), with
    • adequate hematologic, renal, hepatic and cardiac function as per internationally accepted standards.
    E.4Principal exclusion criteria
    Exclusion criteria:
    • operable sarcoma,
    • PS 2 or above,
    • prior systemic treatment with doxorubicin for sarcoma or treatment with ketotifen in the past for other indications.
    • Hypersensitivity to the active substance or to any of the excipients (Magnesium stearate, Maize starch, Pregelatinised maize starch, Lactose monohydrate)
    • Epilepsy
    • Patients being treated with oral antidiabetic agent(s)
    • During Pregnancy and Breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)

    Primary endpoint: confirm that TME reprogramming (change in mechanical properties of tumor) can be objectively assessed on ultrasound measurements of elastography after at least 3 cycles of combination treatment. This marker will represent a mechanical biomarker of response to treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All patients will be subjected to ultrasound imaging after completing 3 cycles of doxorubicin or combination (doxorubicin + ketotifen) treatment and a final measurement will be taken by the completion of 6 cycles.
    E.5.2Secondary end point(s)
    Secondary endpoints: (i) objective response rate (ORR) (which accounts for complete and partial responses) per RECIST 1.1, progression-free and OS and comparison with historical controls. (ii) document potential toxicity from the combination of ketotifen with standard of care systemic treatments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A final analysis is planned after completion of treatment schedule.
    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 No
    E.8.1.1Randomised Yes
    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.8.3 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
    The rationale for assessment after the first 3 cycles is that it provides enough time for the drugs to have an effect. At the same time this is the number of cycles that most patients are likely to complete as some patients will not tolerate chemotherapy until cycle 6.
    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 months18
    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: 5
    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 state10
    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)
    Besides administering the IMP, this trial focuses on giving the patient the standard of practice treatment options available and therefore, the patients in both groups will receive and continue to receive the standard, approved treatment for their sarcoma even after the end of their trial participation and will always be under the care of their treating doctor
    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 Decision2022-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-26
    P. End of Trial
    P.End of Trial StatusOngoing
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