Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-002023-41
    Sponsor's Protocol Code Number:CRC1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-30
    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 number2013-002023-41
    A.3Full title of the trial
    Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC
    Optimalisatie van de behandeling van uitgezaaide dikke darmkanker met cetuximab middels PET imaging.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC
    Optimalisatie van de behandeling van uitgezaaide dikke darmkanker met cetuximab middels PET imaging.
    A.4.1Sponsor's protocol code numberCRC1
    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 SponsorVU University Medical Center
    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 supportKWF-Alpe d’Huzes
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical center
    B.5.2Functional name of contact pointTrial Office
    B.5.3 Address:
    B.5.3.1Street Addressde Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialoffice-onc@vumc.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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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.3.1Product namecetuximab
    D.3.2Product code L01XC06
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 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 namecetuximab-N-SUCDF-89ZR
    D.3.2Product code 89ZR-cetuximab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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: 3
    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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen 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.3.1Product namepanitumumab
    D.3.2Product code L01XC08
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    metastatic colorectal cancer
    uitgezaaide dikke darmkanker
    E.1.1.1Medical condition in easily understood language
    metastatic colorectal cancer
    uitgezaaide dikke darmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    PART I:
    1) to demonstrate 89Zr-cetuximab uptake in non-hepatic tumor lesions at standard dose or at cohort wise increased cetuximab doses (dose escalation). 2) to determine the association between 89Zr-cetuximab uptake in non-hepatic tumor lesions and treatment response.
    3) to determine the association between metabolic change (evaluated with 18F-FDG PET after 2 weeks of treatment) and treatment response.

    PART II
    1)Validate early response evaluation with 18F-FDG PET and the association with treatment benefit.
    2) Evaluate optimal quantification methods for 18F-FDG PET images
    Deel I:
    1) 89Zr-cetuximab opname aantonen in niet-hepatogene tumor laesies bij standard dosering of per cohort opgehoogde dosering cetuximab doses (dose escalatie).
    2) de associatie bepalen tussen 89Zr-cetuximab opname in niet-hepatogene tumor laesies en respons op de behandeling.
    3) De correlatie tussen veranderingen in metabole activiteit van een tumor laesie (bepaald met 18F-FDG PET) na 2 weken behandeling en response op de behandeling bepalen.

    Deel II:
    1) Valideren van de vroege response evaluatie met 18F-FDG PET en de correlatie met behandel voordeel (volgens RECIST v1.1.).
    2) Evalueren wat de optimale quantificatie methode van deze PET scans is (aantal laesies en welke semi-quantitatieve unit).
    E.2.2Secondary objectives of the trial
    - association between levels of uptake of 89Zr-cetuximab in the liver vs. levels of uptake in non-hepatic tumor lesions
    -pharmacokinetics of 89Zr-cetuximab and cetuximab
    -Can the response observed on [18F]-FDG-PET serve as an early response marker for future response to targeted therapy according to RECIST1.1?
    -Explore tumor perfusion with 15O-H2O in a subgroup of patients. These data will serve to explain whether and how 89Zr-cetuximab uptake is a function of tumor perfusion.
    -association between 89Zr-cetuximab uptake in tumor lesions, grade of skin toxicity, serum magnesium concentration abnormalities and response according to RECIST1.1?
    -Relation of tumor and serum microRNA (miRNA) profiles and response to therapy?
    -Study tumor (phospho)proteomic and serum peptide profiles in relation to response to therapy.
    -Study germline and tumor DNA mutation profiles in relation to response to therapy.
    -Study circulating tumors cells (CTCs) in relation to response to therapy.
    -Correlatie tussen 89Zr-cetuximab opname in de lever en opname in andere tumor laesies (geen lever)
    -Farmacokinetiek van 89Zr cetuximab en cetuximab
    -Bestuderen of de uitkomst bepaald d.m.v. [18F]-FDG-PET kan fungeren als een vroege voorspeller voor uitkomst op therapie volgens RECIST1.1
    -Bestuderen van tumor perfusie met 15O- H2O in een patiënten subgroep. Om te verklaren of en hoe 89Zr-cetuximab opname een functie is van tumor perfusie.
    -Bepalen of er een correlatie is tussen 89Zr-cetuximab tumoropname, mate van huidtoxiciteit, serum magnesium concentratie afwijkingen en uitkomst op therapie volgens RECIST1.1
    -Bestuderen of er een relatie is tussen tumor en serum microRNA profielen en uitkomst op therapie
    -Relatie tussen fosfo(protemoics) en serum peptide profielen en uitkomst op therapie?
    -Relatie tussen kiembaan en tumor DNA mutatie profielen en uitkomst op therapie
    -Relatie tussen tumor cellen die in het bloed gevonden kunnen worden en uitkomst op therapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Advanced colorectal adenocarcinoma
    • Subjects must have been treated according to standard care with a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.
    • Age ≥ 18 years.
    • Histological or cytological documentation of cancer is required.
    • Tumor material must be tested wild type for the K-RAS and B-RAF gene.
    • Tumor lesion:
    o Part I: Subjects have at least one measurable lesion ≥ 2 cm outside the liver. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
    o Part II: Subjects have at least one measurable tumor lesion ≥ 1 cm, including liver tumor lesion. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
    • ECOG Performance Status of 0, 1 or 2
    • Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    o Total bilirubin ≤ 1.5 times the upper limit of normal
    o ALT and AST ≤ 2.5 times upper limit of normal (≤ 5 times upper limit of normal for subjects with liver involvement of their cancer)
    o Serum creatinin ≤ 1.5 times upper limit of normal or a calculated creatinin clearance ≥ 50 ml/min
    • Signed informed consent must be obtained prior to any study specific procedures.
    • uitgezaaide dikke darmkanker.
    • patiënten die al standaardtherapie hebben gehad met een fluoropyrimidine (bijv. fluorouracil or capecitabine), irinotecan, and oxaliplatin of deze middelen niet meer verdragen.
    • leeftijd ≥ 18 jaar
    • Histologische of cytologische verslagen van de tumor zijn aanwezig
    • Tumor moet getest zijn op wild type van het K-RAS en B-RAF gen
    • Tumor laesie:
    o Deel 1: patiënten hebben tenminste 1 meetbare laesie ≥ 2 cm buiten de lever. Laesies moeten meetbaar zijn met een CT of MRI volgens Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
    Deel 2: patiënten hebben tenminste 1 meetbare laesie ≥ 1 cm. Laesies moeten meetbaar zijn met een CT of MRI volgens Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
    • WHO-score van 0, 1 of 2
    • Goede lever en nier functies; de volgende labwaarden moeten bepaald worden niet langer dan 7 dagen voor screenen
    o Totale bilirubine ≤ 1.5 keer de normale waarde
    o ALT and AST ≤ 2.5 keer de normale waarde (≤ 5 keer de normale waarde voor patiënten met leverkanker)
    o Serum creatinine ≤ 1.5 keer de normale waarde of een berekende creatinine klaring ≥ 50 ml/min
    • Patienteninformatie moet getekend worden alvorens het onderzoek begint.
    E.4Principal exclusion criteria
    • Previous exposure to an anti-EGFR therapy
    • Significant skin condition interfering with treatment
    • Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
    • Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
    • Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed.
    • Major surgery within 28 days of start of study drug.
    • Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
    • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
    • Eerdere behandeling met een anti-EGFR middel
    • Slechte huidconditie die met de behandeling interfereert.
    • zwangere vrouwen of vrouwen die borstvoeding geven. Vruchtbare vrouwen moeten een negatieve zwangerschapstest hebben. Deze moet binnen 7 dagen voor start van de behandeling uitgevoerd worden. Zowel mannen als vrouwen moeten anticonceptie gebruiken gedurende de studie (zoals een pessarium, condoom). Orale anticonceptie wordt niet beschouwd als geschikte anticonceptie, omdat het met de farmacokinetiek van de studiemedicatie kan interfereren. Het gebruik van orale en niet-orale anticonceptie strekt tot aanbeveling. Het gebruik van anticonceptie is 6 maanden na het onvangen van de laatste dosis van de studiemedicatie noodzakelijk.
    • Gelijktijdige toediening van chemotherapie, immunotherapie, of een ander antikankermiddel tijdens de studie of 4 weken voor start van de studie.
    • Radiotherapie van de target laesies tijdens de studie of 4 weken voor start van de studie. Pallitatieve radiotherapie is wel toegestaan.
    • Een ingrijpende operatie 28 dagen voor start studie
    • Drugsmisbruik, medische, psychologische of sociale condities die kunnen interfereren met deelname aan de studie of evaluatie van de studie resultaten.
    • Elke conditie die niet stabiel is voor de proefpersoon of de proefpersoon in gevaar kan brengen en/of haar/zijn deelname aan de studie kan belemmeren.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1A:
    89Zr-cetuximab uptake in non-hepatic metastases (corrected VOIs);
    Clinical benefit rate (CBR).

    Part 1B:
    89Zr-cetuximab uptake in non-hepatic metastases with increased dosing of cetuximab (corrected VOIs).

    Part 2:
    Association between CBR and early response evaluation using 18F-FDG PET. CBR is defined as the sum of CR, PR and SD according to RECIST 1.1 at 3 months after treatment start. Corrected VOIs are defined as measurements in VOI corrected for background levels.
    Deel1A:
    89Zr-cetuximab opname in de metastase (geen lever)
    Mate van klinische effectiviteit.

    Deel 1B:
    89Zr-cetuximab opname in de metastasen (geen lever) bij oplopende dosering van cetuximab.

    Deel 2:
    klinische baten van cetuximab (standaard dosering) en de correlatie met de uitkomsten van de vroege evaluatie met 18F-FDG PET.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 - 6 years after study commences
    4 - 6 jaar na start studie
    E.5.2Secondary end point(s)
    1) The % uptake (of total injected) 89Zr-cetuximab in non-tumor liver tissue and hepatic metastases (corrected VOIs).
    2) 18F FDG-PET uptake before and after 2 weeks of cetuximab treatment.
    3) Grade of skin toxicity as measured by predefined criteria.
    1) percentage opname (van totaal geinjecteerde) 89Zr-cetuximab in de niet lever metastasen en metastase in de lever.
    2) 18F FDG-PET opname voor en na 2 weken cetuximab behandeling.
    3) Mate van huid toxiciteit
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 - 6 years after study commences
    1 year follow-up and data analysis
    4 - 6 jaar na start studie
    1 jaar follow-up en data analyse
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    interventie
    intervention
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 study has a two stage design. If in the first stage, 10 patients do not show uptake of 89Zr cetuximab in a non-hepatic tumour lesion, the study will be halted.
    De studie bestaat uit 2 delen. Indien er in het eerste deel van de studie geen 89Zr cetuximab opname in tumor laesies buiten de lever wordt geobserveerd in de eerste 10 patienten, wordt de studie beeindigd.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state151
    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 available, 4th line treatment, regorafenib, is an option for these patient
    Een 4e lijns behandeling is nog mogelijk voor deze patienten, namelijk regorafenib, wanneer deze beschikbaar is.
    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 Decision2013-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-07
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA