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    Summary
    EudraCT Number:2015-005784-17
    Sponsor's Protocol Code Number:REGORA
    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:2016-03-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-005784-17
    A.3Full title of the trial
    The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib in patients with a metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumour (GIST).
    De effecten van de protonpomp remmer esomeprazole op de biologische beschikbaarheid van regorafenib bij patienten met gemetastaseerde colorectal kanker of gastro-intestinale stromale tumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib
    De effecten van de protonpomp remmer esomeprazole op de biologische beschikbaarheid van regorafenib
    A.3.2Name or abbreviated title of the trial where available
    REGORA
    A.4.1Sponsor's protocol code numberREGORA
    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 supportBayer Pharma AG
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC cancer institute
    B.5.2Functional name of contact pointF.M. de Man, MD
    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-mailf.deman@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 Stivarga
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPEnteral use (Noncurrent)
    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.IMP: 2
    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 Nexium
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    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 IMPEnteral use (Noncurrent)
    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
    GIST and mCRC patients
    GIST en mCRC patienten
    E.1.1.1Medical condition in easily understood language
    Gastro-intestinal stromal tumour patients and metastatic colorectal carcinoma patients
    Gastro-intestinale stromale tumoren patienten en gemetastaseerd colorectal carcinoom patienten
    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 evaluate the area under the curve (AUC) of regorafenib compared to regorafenib concomitantly used with esomeprazole and to regorafenib used with esomeprazole 3 hours prior in patients with mCRC or GIST.
    Het bepalen van de invloed van esomeprazol op de AUC van regorafenib bij gelijktijdig gebruik en bij 3 uur eerder inname van de esomeprazol bij patienten met gemetastaseerd CRC of GIST
    E.2.2Secondary objectives of the trial
    1. Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax) and time to Cmax (tmax)).
    2. To evaluate the incidence and severity of side-effects of treatment with regorafenib in absence and presence of esomeprazole
    1.Andere pharmacokinetische uitkomsten (zoals klaring, de maximale concentratie (Cmax) en de tijd tot Cmax (tmax).
    2.Het evalueren van de incidentie en ernst van de bijwerkingen van een behandeling met regorafenib in de aan- en afwezigheid van esomeprazole
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Histological or cytological confirmed diagnosis of mCRC or GIST
    3. ECOG Performance Status ≤ 1
    4. Signed Informed Consent Form prior to screening evaluations
    5. No concurrent (over the counter) use of other acid reducing drugs, other than esomeprazole 40mg (PPIs, H2As and/or antacids) once daily during the study.
    6. No concurrent medication or supplements which can interact with esomeprazole or regorafenib during the study period.
    7. Abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study period.
    8. Adequate baseline patient characteristics
    1. Leeftijd ≥ 18 jaar
    2. Histologisch of cytologisch bevestigde diagnose van mCRC of GIST
    3. ECOG Performance Status ≤ 1
    4. Getekend Informed Consent Form voor de screening
    5. Geen gebruik van andere zuurremmende medicatie anders dan esomeprazole 40mg
    6. Geen gebruik van medicatie of supplementen die een interactie kunnen hebben met esomeprazole of regorafenib
    7. Geen gebruik van grapefruit, grapefruit sap, kruiden supplementen of kruidenthee
    8. Adequate baseline karakteristieken
    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
    4. Patients with evidence or history of any bleeding diathesis, irrespective of severity
    5. Cardiac history ( recent myocardial infarction, unstable or new-onset angina, uncontrolled cardiac arrhythmias)
    6. Uwillingness to abstain from grapefruit (juice), (herbal) dietary supplements, herbals, over-the-counter medication (except for paracetamol and ibuprofen) and other drugs known to seriously interact with esomeprazole and regorafenib during the study period.
    7. Unwillingness to abstain from acid beverages such as jus d’orange and other acidic beverages in the morning during regorafenib treatment in this study.
    8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    9. Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent.
    1. Zwanger of het geven van borstvoeding
    2. Patienten met een bekende verminderde absorptive van medicatie
    3. Bekende ernstige ziekte of medisch instabiele conditie die kan interfereren met de studie
    4. Patienten met een geschiedenis van bloedingsneiging
    5. Cardiale voorgeschiedenis (recent myocardinfarct, onstabiele of recent ontstane angina, ongecontroleerde ritmestoornissen)
    6. Niet bereid om te stoppen met grapefruit (sap), kruidensupplementen, kuiden, zelhulpmedicatie (behalve paracetamol en ibuprofen) en andere medicatie die interactie kan hebben met esomeprazol en regorafenib.
    7. Niet bereid om te stoppen met zure dranken zoals jus d’orange in de ochtend tijdens de behandeling met regorafenib.
    8. Overgevoeligheid voor een van de studie medicijnen of bestandelen ervan
    9. Symptomatische CZS metastases of voorgeschiedenis van psychiatrische ziekte die een goede informed consent procedure verhindert.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the area under the curve (AUC) of regorafenib compared to regorafenib concomitantly used with esomeprazole and to regorafenib used with esomeprazole 3 hours prior in patients with mCRC or GIST.
    Het bepalen van de invloed van esomeprazol op de AUC van regorafenib bij gelijktijdig gebruik en bij 3 uur eerder inname van de esomeprazol bij patienten met gemetastaseerd CRC of GIST
    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)).
    2. To evaluate the incidence and severity of side-effects of treatment with regorafenib in absence and presence of esomeprazole
    1.Andere pharmacokinetische uitkomsten (zoals klaring, de maximale concentratie (Cmax) en de tijd tot Cmax (tmax).
    2.Het evalueren van de incidentie en ernst van de bijwerkingen van een behandeling met regorafenib in de aan- en afwezigheid van esomeprazole
    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 No
    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
    Cross-over design, elke patient is zijn eigen controle
    Cross-over design, each patient is his own control
    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 bezoek van laatste studiepatient
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with incurable diseases
    Patienten met een ongeneesbare ziekte
    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)
    Patients can continue the use of regorafenib post trial
    Patienten kunnen regorafenib doorgebruiken na het einde van de studie
    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 Decision2016-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
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