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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2009-010715-32
    Sponsor's Protocol Code Number:20080763
    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:2010-02-12
    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 number2009-010715-32
    A.3Full title of the trial
    A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the
    Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously
    Treated, Wild-type KRAS, Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code number20080763
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Vectibix 20mg/ml concentration for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVectibix
    D.3.2Product code AMG 954
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPanitumumab
    D.3.9.2Current sponsor codeAMG 954
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameErbitux
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.3Other descriptive nameErbitux
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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 is to compare the effect of panitumumab versus cetuximab on
    overall survival (OS) for chemorefractory mCRC among subjects with wild-type KRAS
    tumors.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare the treatment effect of panitumumab versus
    cetuximab as treatment for chemorefractory mCRC among subjects with wild-type KRAS
    tumors:
    • Efficacy: progression-free survival (PFS), objective response rate (ORR), time to
    response, time to treatment failure, duration of response
    • Safety: subject incidence of AEs, significant laboratory changes, and immunogenicity
    • Patient Reported Outcomes (PRO)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
    colon or rectum
    Metastatic disease
    Wild-type KRAS tumor status by protocol-specified testing (see Section 7.10)
    Formalin-fixed paraffin-embedded tumor tissue from either the primary
    tumor or a metastatic lesion must be submitted for biomarker testing (see
    Section 7.10)
    ECOG performance status of 0, 1 or 2
    Measurable or non-measurable disease per RECIST version 1.1
    Must have failed a prior regimen containing irinotecan for metastatic disease and
    a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and
    irinotecan may have been administered sequentially or in combination.
    Failure is defined as either disease progression (clinical or radiological) or
    intolerance to the regimen
    Subjects in whom relapse is diagnosed within 6 months after completing
    adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing
    regimen) will be considered as having failed a prior regimen for metastatic
    disease
    Must have previously received a thymidylate synthase inhibitor (e.g. fluorouracil,
    capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
    Man or woman ≥ 18 years of age
    Hematologic function, as follows: (≤ 10 days prior to randomization)
    Absolute neutrophil count (ANC) ≥ 1.5 x 10 to the power of 9/L
    Platelet count ≥ 75 x 10 to the power of 9/L
    Hemoglobin ≥ 8.0 g/dL
    Renal function, as follows: (≤ 10 days prior to randomization)
    Creatinine ≤ 1.5 x ULN
    Hepatic function, as follows: (≤ 10 days prior to randomization)
    Aspartate aminotransferase (AST) ≤ 3 x ULN (if liver metastases
    ≤ 5 x ULN)
    Alanine aminotransferase (ALT) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
    Total bilirubin ≤ 1.5 x ULN
    Metabolic function, as follows: (≤ 10 days prior to randomization)
    Magnesium ≥ lower limit of normal
    Negative pregnancy test ≤ 72 hours before randomization (for women of
    childbearing potential only)
    Competent to comprehend, sign, and date a written IEC/IRB approved informed
    consent form before any study-specific procedure
    E.4Principal exclusion criteria
    Symptomatic brain metastases requiring treatment
    History of other malignancy, except:
    Malignancy treated with curative intent and with no known active disease
    present for ≥ 5 years prior to randomization and felt to be at low risk for
    recurrence by the treating physician
    Adequately treated non-melanomatous skin cancer or lentigo maligna
    without evidence of disease
    Adequately treated cervical carcinoma in situ without evidence of disease
    Prostatic intraepithelial neoplasia without evidence of prostate cancer
    Known hypersensitivity to any of the protocol-specified agents or their excipients
    Prior anti-EGFr antibody therapy (eg, panitumumab or cetuximab) or treatment
    with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
    Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy,
    antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days
    before randomization. Subjects must have recovered from any acute toxicity
    Subject previously randomized to this study
    Other investigational procedures ≤ 30 days before randomization
    Subject currently is enrolled in or ≤ 30 days from ending other investigational
    device or drug study(s)
    Major surgery (eg, requiring general anesthesia) ≤ 28 days before randomization.
    Subjects must have recovered from any surgery related toxicities
    Clinically significant cardiovascular disease (as defined by: unstable angina,
    symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
    Myocardial infarction within last 6 months before randomization
    History of interstitial lung disease (ILD), eg, interstitial pneumonitis, pulmonary
    fibrosis or evidence of interstitial lung disease on baseline chest CT or MRI
    History of any medical or psychiatric condition or laboratory abnormality that in
    the opinion of the investigator may increase the risk associated with the study
    participation or investigational product(s) administration or may interfere with the
    interpretation of the results
    Subject pregnant or breast feeding, or planning to become pregnant during
    treatment and within 6 months after the end of treatment
    Subject (male or female) is not willing to use highly effective methods of
    contraception (per institutional standard) during treatment and for an additional
    6 months (males and females) after the end of treatment
    Known positive test(s) for human immunodeficiency virus infection (testing is not
    required in the absence of clinical suspicion)
    Active infection requiring systemic treatment or any uncontrolled infections
    ≤14 days prior to randomization
    Subject has any kind of disorder that compromises the ability of the subject to
    give written informed consent and/or to comply with study procedures or is
    unwilling or unable to comply with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    Primary
    • OS: time from randomization date to date of death. Subjects who have not died by
    the analysis data cutoff date will be censored at their last contact date.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.3.1Comparator description
    Cetuximab
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of study for each subject is defined as the date the subject withdraws consent from the study, completes the final long-term follow-up visit, or dies.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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.1.3Elderly (>=65 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 361
    F.4.2.2In the whole clinical trial 1000
    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 Decision2010-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-03
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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