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    Summary
    EudraCT Number:2016-004008-71
    Sponsor's Protocol Code Number:ELDORADO
    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:2016-11-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004008-71
    A.3Full title of the trial
    The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with estrogen receptor positive breast cancer ‘the ELDORADO study’
    Het effect van kurkuma en piperine op de farmacokinetiek van tamoxifen bij patiënten met oestrogeenreceptor positieve borstkanker "de ELDORADO studie"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of curcumin and piperine on tamoxifen metabolism in patients breast cancer ‘the ELDORADO study’
    Het effect van kurkuma en piperine op het metabolisme van tamoxifen bij patiënten met borstkanker 'de ELDORADO studie'
    A.4.1Sponsor's protocol code numberELDORADO
    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 SponsorErasmus MC Cancer Institute
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointRon Mathijssen
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.6E-maila.mathijssen@erasmusmc.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 Tamoxifen
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Pharmaceuticals Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Coated 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
    Estrogen receptor positive breast cancer
    Oestrogeen receptor positieve borstkanker
    E.1.1.1Medical condition in easily understood language
    Hormone sensitive breast cancer
    Hormoongevoelige borstkanker
    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
    To determine the influence of curcumin with or without piperine, in patients with estrogen receptor positive breast cancer, on tamoxifen/endoxifen plasma pharmacokinetics (AUC).
    De invloed van kurkuma met of zonder piperine, in patiënten met oestrogeen receptor positieve borstkanker, op de tamoxifen/endoxifen plasma farmacokinetiek.
    E.2.2Secondary objectives of the trial
    1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)) and the tamoxifen/endoxifen ratio.
    2. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of curcumin with or without piperine.
    1. andere farmacokinetische uitkomsten (klaring, maximale concentratie (Cmax) en tijd tot Cmax (tmax) en de tamoxifen/endoxifen ratio.
    2. de incidentie en ernst van bijwerkingen evalueren bij behandeling met tamoxifen in de aan- of afwezigheid van kurkuma met of zonder piperine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Histological or cytological confirmed diagnosis of estrogen receptor positive breast cancer in patients with an indication for tamoxifen treatment.
    3. WHO Performance Status ≤ 1
    4. Able and willing to sign the Informed Consent Form prior to screening evaluations
    5. Abstain from curry, grapefruit (juice), (herbal) dietary supplements besides curcumin, herbals, over-the-counter medication (except for paracetamol and ibuprofen).
    6. Adequate baseline patient characteristics (complete blood count, and serum biochemistry which involves sodium, potassium, creatinin, calculation of creatinin clearance (MDRD), AST, ALT, gamma glutamyltranspeptidase (GGT), lactate dehydrogenase (LDH), ALP, total bilirubin, albumin).
    1. Leeftijd ≥ 18 jaar
    2. histologisch of cytologisch bevestigde diagnose van oestrogeen receptor positieve borstkanker in patiënten met een indicatie voor tamoxifen behandeling.
    3. WHO performance status ≤ 1
    4. In staat en welwillend om het informed consent formulier te tekenen voorafgaand aan screening
    5. Patiënt moet zich wilen onthouden van currie, grapefruit (sap), (kruiden) dieet supplementen naast kurkuma, kruiden, over-the-counter medicatie (behalve paracetamol en ibuprofen)
    6. adequate baseline patient karakteristieken (volledig bloedbeeld, biochemie wat natrium, kalium, kreatinine, MDRD, ASAT, ALAT, Gamma glutamyltranspeptidase (GGT), lactaatdehydrogenase (LDH), alkalische fosfatase (AF), totaal billirubine, albumine)
    E.4Principal exclusion criteria
    1. Pregnant or lactating patients.
    2. Patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria).
    3. Known serious illness or medical unstable conditions that could interfere with this study; requiring treatment (e.g. infection, bleedings, uncontrolled hypertension despite optimal medical management, HIV, hepatitis, organ transplants, kidney, cardiac and respiratory diseases).
    4. Bilirubin CTCAE grade 3 or higher, ASAT/ALAT CTCAE grade 3 or higher. Renal function impairment CTCAE grade 3 or higher.
    5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication).
    6. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
    7. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    8. Patients on strong CYP3A4 or CYP2D6 inhibitors or inducers, P-gp substrates or medication or supplements which can interact with tamoxifen and curcumin are not eligible for the study.
    1. zwangeren of patiënten, die borstvoeding geven
    2. patiënten met verminderde medicijn absorptive (bijvoorbeeld gastrectomie en achlorhydrie)
    3. bekende serieuze ziekte of medisch onstabiele condities die met deze studie kunnen interfereren; behandeling behoeven (bijvoorbeeld infectie, bloedingen, ungecontroleerde hypertensie ondanks optimale behandeling, HIV, hepatitis, orgaantransplantatie, nier-, hart of longziekten)
    4. billirubine, ASAT/ALAT of nierfunctieverslechtering CTCAE graad 3 of hoger.
    5. Arteriele of veneuze trombotische of embolische events zoals CVA, diep veneuze trombose of longembolie binnen 6 maanden voorafgaand aan start van studie medicatie. (behalve voor adequaat behandelde catheter- geraleteerde veneuze trombose, die op is getreden meer dan een maand voor start van studie medicatie)
    6. symptomatische centraal zenuwstelsel metastasen of een voorgeschiedenis van psychiatrische ziekten die het begrijpen en geven van informed consent in de weg staan.
    7. bekende overgevoeligheid voor de studiemedicatie of bestanddelen in de formulatie.
    8. patiënten met een sterke CYP3A4 of CYP2D6 inhibitor of inducer, P-gp substraat of medicatie of supplementen die een interactie kunnen hebben met tamoxifen en kurkuma zijn niet geschikt voor deelname aan de studie.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the influence of curcumin with or without piperine, in patients with estrogen receptor positive breast cancer, on tamoxifen/endoxifen plasma pharmacokinetics (AUC).
    De invloed van kurkuma met of zonder piperine, in patiënten met oestrogeen receptor positieve borstkanker, op de tamoxifen/endoxifen plasma farmacokinetiek.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Einde van de studie
    E.5.2Secondary end point(s)
    1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)) and the tamoxifen/endoxifen ratio.
    2. To evaluate the incidence and severity of side-effects of treatment with tamoxifen in absence and presence of curcumin with or without piperine.
    1. andere farmacokinetische uitkomsten (klaring, maximale concentratie (Cmax) en tijd tot Cmax (tmax) en de tamoxifen/endoxifen ratio.
    2. de incidentie en ernst van bijwerkingen evalueren bij behandeling met tamoxifen in de aan- of afwezigheid van kurkuma met of zonder piperine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Einde van de studie
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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
    the comparator is a herb drug (curcumin and piperine)
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    laatste visite van de laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state24
    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 continue the use of tamoxifen post trial according to regular treatment protocol
    Patiënten kunnen doorgaan met tamoxifen na de studie volgens het reguliere behandelprotocol
    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 Decision2016-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
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