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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7258   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2017-004163-12
    Sponsor's Protocol Code Number:RP2017-001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2017-004163-12
    A.3Full title of the trial
    A phase 2a TDM-guided clinical study on the safety and efficacy of mebendazole in patients with advanced gastrointestinal cancer or cancer of unknown origin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study on the safety and efficacy of mebendazole in patients with advanced gastrointestinal cancer or cancer of unknown origin
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberRP2017-001
    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 SponsorReposPharma
    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 supportReposPharma
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReposPharma
    B.5.2Functional name of contact pointMårten Fryknäs
    B.5.3 Address:
    B.5.3.1Street AddressDept. Of Clinical Pharmacology, Uppsala University Hospital
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.4Telephone number46186112931
    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 nameRepos MBZ
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEBENDAZOLE
    D.3.9.1CAS number 31431-39-7
    D.3.9.2Current sponsor codeRepos MBZ
    D.3.9.4EV Substance CodeSUB08660MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Squamous cell cancer or adenocarcinoma, including primary cancer of the liver, of the gastrointestinal tract or cancer of unknown origin
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017985
    E.1.2Term Gastrointestinal neoplasm malignant
    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
    · Safety profile of Repos MBZ.
    · Anti-tumour efficacy: tumour response rate and prolongation of time to tumour progression (TTP) according to RECIST 1.1.
    E.2.2Secondary objectives of the trial
    · The single dose pharmacokinetic (PK) profile of Repos MBZ.
    · The steady state PK profile of Repos MBZ.
    · Repos MBZ induced changes in blood cytokines and immune cells.
    · Overall survival.
    · Change in tumour load and TTP according to irRECIST
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age.
    2. Histologically confirmed diagnosis of squamous cell cancer or adenocarcinoma, including primary cancer of the liver, of the gastrointestinal tract or cancer of unknown origin.
    3. Measurable disease according to RECIST 1.1.
    4. Defined time to tumour progression on the standard/experimental treatment preceding the trial treatment.
    5. Locally advanced or metastatic disease not amenable to standard treatment, i.e. progress on
    standard therapy or observed/expected intolerance to standard therapy.
    6. -
    7. Pharmacological treatment attempt considered reasonable.
    8. Females of childbearing potential should use adequate contraception throughout the study;
    a. Combined (estrogen and progestogen containing) hormonal contraception associated
    with inhibition of ovulation (oral, intravaginal or transdermal)
    b. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
    c. Intrauterine device (IUD)
    d. Intrauterine hormone-releasing system (IUS)
    e. Bilateral tubal occlusion
    f. Vasectomized partner
    g. Sexual abstinence
    9. Signed informed consent.
    E.4Principal exclusion criteria
    1. Anti-tumour therapy within 3 weeks prior to study drug administration day 1.
    2. Ongoing infection or other major recent or ongoing disease that, according to the Investigator’s assessment, poses an unacceptable risk to the patient.
    3. WHO performance status ≥ 2.
    4. Child-Pugh B or C liver function status if hepatocellular carcinoma.
    5. Inadequate laboratory parameters reflecting major organ function i.e.:
    a. neutrophils ≤ 1,3 x 109/l
    b. platelets ≤ 100 x 109/l
    c. bilirubin > 1.5 x ULN
    d. ALAT > 5 x ULN
    e. GFR <50 ml/min (calculated from P-creatinine)
    f. prothrombin complex/INR outside normal range
    6. Current active participation in any other interventional clinical study.
    7. Contraindications to the investigational product, e.g. known or suspected hypersensitivity
    or inability to oral drug administration.
    8. Pregnancy or lactation.
    9. Lack of suitability for participation in the study, e g expected difficulties to follow the
    protocol procedures, as judged by the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    · Number of AEs probably or possibly related to the study drug, graded according to CTCAE 4.03
    · Changes in lab parameters and vital sign over time vs baseline

    · Best overall radiological response according to RECIST 1.1.
    · Time to tumour progression on Repos MBZ compared with time to progression on the treatment just preceding participation in this protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously during treatment and up to 0-30 days after treatment stop.

    Every 8 weeks during study / until progress.
    E.5.2Secondary end point(s)
    · Cmax, Tmax and T1/2 after single dose Repos MBZ.
    · Number of patients that reach the steady state S-mebendazole target concentration of 300 ng/ml (accepted range 250 – 350 ng/ml), time to reach this concentration and S-mebendazole concentration variation over time.
    · Immunological changes induced by mebendazole from baseline, as reflected in cytokines and immune cells in blood
    · Overall survival from start of treatment phase to death from any cause.
    · Best overall radiological response according to irRECIST 1.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK-parameters will be assesed weekly until target concentration is reached . Then PK will be assessed every 4 weeks.
    Survival will be followed up until time to death.
    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 Yes
    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. 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.8.3 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
    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 months3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state50
    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 can be treated with IMP after end of study, if it is considered to benefit the patient.
    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 Decision2018-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-16
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