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    Summary
    EudraCT Number:2016-000092-24
    Sponsor's Protocol Code Number:56286
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-03-16
    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 number2016-000092-24
    A.3Full title of the trial
    The PLCRC substudy Ultra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases – a proof of concept study
    De PLCRC substudie Ultra hoog veld 7.0 Tesla MR Sprectroscopie voor het monitoren van het capecitabine metabolisme in lever metastasen - een proof of concept studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ultra high field 7.0 Tesla MR Spectroscopy to monitor capecitabine metabolism in liver metastases – a proof of concept study
    Ultra hoog veld 7.0 Tesla MR Sprectroscopie voor het monitoren van de stofwisseling van capecitabine in uitzaaiingen in de lever - een proof of concept studie
    A.3.2Name or abbreviated title of the trial where available
    The PLCRC - SPECTRE study
    De PLCRC - SPECTRE studie
    A.4.1Sponsor's protocol code number56286
    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 Medical Center Utrecht
    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 supportno
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointSophie Kurk
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3508GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31887569678
    B.5.5Fax number+31887555557
    B.5.6E-mails.a.kurk@umcutrecht.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Capecitabine
    D.2.1.1.2Name of the Marketing Authorisation holderAccord healthcare bv.
    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
    Colorectal carcinoma
    Colorectaal carcinoom
    E.1.1.1Medical condition in easily understood language
    Bowel cancer
    dikkedarm- en endeldarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10010036
    E.1.2Term Colorectal carcinoma
    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
    The primary objective of this feasibility/pilot study is to find the correct scanning protocol to assess 5FU drug trapping in colorectal cancer liver metastases using 7T MRS (phase 1).The primary objective is to find the correct scanning protocol to assess 5FU drug trapping in colorectal cancer liver metastases using 7T MRS.
    Het primaire doel van de studie is het ontwikkelen van een scanprotocol voor het meten van drugtrapping van 5FU in levermetastasen op basis van colorectaal carcinoom middels 7T MRS.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be assessed during phase 2 of this study and include applying the developed scanning protocol to explore the correlation between 5FU drug trapping in liver metastasis to the efficacy of treatment according to the Response Evaluation Criteria In Solid Tumors (RECIST) and to explore whether metabolite levels correlate to perfusion, diffusion and acidity as determined by functional MRI
    Secundaire doelenjn betreffen het toepassen van het ontwikkelde scanprotocol voor het exploreren van de relatie tussen 5FU drug trapping in lever metastasen en de effectiviteit van de behandeling volgens RECIST en het exploreren van een correlatie tussen de concentratie van metabolieten en perfusie, diffusie en zuurgraad zoals gemeten middels functionele MRI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -18 years or older.
    -Patients with liver metastases measurable according to RECIST in metastatic colorectal cancer.
    -Patients that are planned to start with capecitabine (Xeloda®) and bevacizumab (Avastin®) treatment as determined according to Dutch guidelines.
    -Informed consent for longitudinal data collection according to the PLCRC study protocol.
    -Minimale leeftijd van 18 jaar.
    -Patiënten met volgens RECIST meetbare lever metastasen op basis van uitgezaaid colorectaal carcinoom.
    -Patienten die zullen starten met een behandeling middels capecitabine en bevacizumab conform de geldende Nederlandse richtlijnen.
    -Informed consent voor het verzamelen van longitudinale klinische data volgens het PLCRC studie protocol.
    E.4Principal exclusion criteria
    - Patients that received any prior systemic therapy for cancer.
    - Patients that received any prior radiotherapy or surgery in the liver.
    - Contra-indications to MRI scanning according to hospitals 7T MRI screening guideline of the UMCU.
    - Patients with severe liver dysfunction.
    - Patients with a life expectancy of < 3 months.
    - Pregnant or lactating women.
    - Patients with claustrofobia.
    - Patiënten die eerder zijn behandeld met systeemtherapie voor kanker
    - Patiënten die eerder zijn behandeld met radiotherapie of chirurgie in de lever
    - Contra-indicatie voor het krijgen van een MRI scan volgens de geldende screening richtlijnen voor 7T MRI in het UMCU
    - Patienten met ernstig leverfalen
    - Patient met een levensverwachting van minder dan 3 maanden
    - Zwangeren of vrouwen die borstvoeding geven
    - Patienten met claustrofobie
    E.5 End points
    E.5.1Primary end point(s)
    7T MRS characteristics on (changes in) concentration of capecitabine and metabolites measured in liver metastasis during MRS examinations obtained at discretized time point(s).
    7T MRS karakteristieken op (veranderingen) in concentratie van capecitabine en metabolieten gemeten in lever metastasen tijdens MRS onderzoeken.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After inclusion of the first 6 patients.
    Na inclusie van de eerste 6 patienten.
    E.5.2Secondary end point(s)
    -Secondary endpoints include response measurements (complete response, partial response, stable disease and progressive disease) according to RECIST
    -Are the metabolite levels correlated to perfusion, diffusion and acidity as determined by functional MRI.
    Respons metingen volgens RECIST (complete respons, partiele respons, stabiele ziekte, en progressie)
    Gedetailleerde informatie over perfusie, diffusie en zuurgraad gemeten middels functionele MRI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    When 26 patients finished their first three cycles of capecitabine and bevacizumab.
    Nadat 26 patienten de eerste 3 cycli van de behandeling met capecitabine en bevacizumab hebben afgerond.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    proof of concept for MRS, not for study medication
    proof of concept for MRS, niet voor studie medicatie
    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.8.2.4Number 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 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
    This trial will be ended when 26 patients that participated in this study (i.e. participated in MRS examinations) finished the first three cycli of treatment with capecitabine and bevacizumab
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state26
    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)
    When both phases of this study will be completed, the results of this study will be used to assess feasibility and sample size calculations for a large continuing study on the assessment of metabolism of capecitabine and treatment efficacy using 7T MRSI.
    Bij afronden van beiden fasen van dit onderzoeken zullen de resultaten gebruikt worden voor het opzetten van een grotere opvolgende studie naar het metabolisme van capecitabine en effectiviteit van de behandeling middels 7T MRS.
    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 Decision2016-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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