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    Summary
    EudraCT Number:2009-013279-23
    Sponsor's Protocol Code Number:NCT-2008-11-02-1020
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-013279-23
    A.3Full title of the trial
    In vivo response monitoring of treatment with the EGFR-monoclonal-antibody Cetuximab in metastatic colorectal cancer – a single center phase II study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Response monitoring with special chemotherapie (monoclonal antibody) in metastatic colorectal cancer
    A.3.2Name or abbreviated title of the trial where available
    REMOTUX
    A.4.1Sponsor's protocol code numberNCT-2008-11-02-1020
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN75334801
    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 Hospital of Heidelberg
    B.1.3.4CountryGermany
    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 supportMerck Serono GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Heidelberg
    B.5.2Functional name of contact pointNCT Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 350
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number496221566296
    B.5.5Fax number496221565863
    B.5.6E-mailjennifer.ose@med.uni-heidelberg.de
    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 Pharma GmbH
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 400
    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) 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
    metastatic colorectal cancer
    E.1.1.1Medical condition in easily understood language
    colorectal cancer with metastasis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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
    •To evaluate the prognostic relevance of relative changes in SUV (as measured in 18F-FDG PET-CT at day 14 versus baseline) for early clinical response (as defined by RECIST, measured at day 56) during short-term single agent treatment with the EGFR-mAB cetuximab
    E.2.2Secondary objectives of the trial
    • To investigate duration of PFS as well as the influence of changes in individual SUV
    and early clinical response on PFS.
    • To investigate duration of OS and its association with SUV.
    • The assessment of antivascular/antiangiogenic effects of cetuximab by contrast-enhanced ultrasound.
    • This clinical trial will include an accompanying research component involving collection of biological samples for pseudonymized analyses. These will comprise sequential serum protein marker assessments (e.g. multiplex cytokine immune monitoring) as well as baseline analysis of tumor proteins and tumor genes, (like e.g. PTEN expression, mutations in EGFR dependent downstream kinases like PI-3-kinase, BRAF and EGFR gene expression as measured by fluorescence-in-situ-hybridization). Patients may participate in this study even if they choose not to participate in this component.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There will be a sub-study. If special written informed consent for translational research is available, 20 ml of venous blood will be taken at baseline and on day 14 for cytokine immune monitoring during the study. The samples will immediately be brought to the processing laboratory at the NCT. PTEN and other tumor protein and tumor gene expression analyses will be performed on the existing pre-therapeutic biopsy specimen, if available.
    E.3Principal inclusion criteria
    • Histologically confirmed metastatic colorectal cancer
    • RAS-wildtype status of the tumor
    • No history of therapy with an EGFR targeting agent
    • No history of previous chemotherapy for advanced disease
    • Measurable tumor lesion with a diameter no smaller than 1.0 cm detected by CT, MRI
    or ultrasound
    • For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm
    • ECOG-performance status 0 or 1 or Karnofsky performance scale min. 70%
    • Life expectancy > 12 weeks
    • Age ≥ 18 years
    • Adequate hematologic, renal and hepatic function
    • Ability of the patient to understand the character and individual consequences of this clinical trial
    • Written informed consent (must be available before enrolment in the trial)
    • For women and men with childbearing potential adequate double barrier contraception, for women: negative pregnancy test
    • Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    E.4Principal exclusion criteria
    • Any contraindications for chemotherapy according to the Folfiri regimen
    • Non-curatively treated malignancy within the last 5 years
    • Uncontrolled or insulin-dependent diabetes mellitus
    • Evidence of CNS metastases
    • Uncontrolled infection
    • Significant cardiac disease (unstable angina pectoris or cardiac symptoms according to NYHA classification III or IV)
    • Active serious illness which renders the patient unsuitable for study entry or multiple blood sampling
    • Pregnancy and lactation
    • History of hypersensitivity to cetuximab or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
    • Participation in other competing clinical trials or observation period of competing trials, respectively
    • No patient will be allowed to enroll in this trial more than once.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint: • Clinical response: Responders are defined as patients achieving partial or complete responses as measured by RECIST at day 56.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint will be evaluated by the following parameters:
    • Metabolic tumor response will be evaluated by means of 18F-FDG PET-CT on baseline and day 14 (after 2 weeks of single-agent treatment with cetuximab).
    E.5.2Secondary end point(s)
    • To investigate duration of PFS as well as the influence of changes in individual SUV
    and early clinical response on PFS.
    • To investigate duration of OS and its association with SUV.
    • The assessment of antivascular/antiangiogenic effects of cetuximab by contrast-enhanced ultrasound.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Antivascular/ antiangiogenic effects of cetuximab (i. e., on relative blood volume and perfusion) will be evaluated by contrast-enhanced ultrasound on baseline and day 14.
    • Clinical response will be evaluated according to RECIST with a routine CT scan on day 56 in comparison with the baseline analysis.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Patients will be followed up until death

    cut off date 24 months after last subject out
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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: 19
    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 state35
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 35
    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)
    Treatment will be continued according to the choice of the responsible physician. It is recommended that, in case of response, treatment will be continued with cetuximab and the Folfiri regimen until disease progression or patients are unable to tolerate the therapy. Patients will be followed-up every 3 months.
    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 Decision2010-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-21
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