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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2006-006739-36
    Sponsor's Protocol Code Number:20060314
    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:2007-04-02
    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 number2006-006739-36
    A.3Full title of the trial
    A Single Arm Multicentre Phase II Study of Panitumumab in Combination with Irinotecan/5-Fluorouracil/Leucovorin in Patients with Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code number20060314
    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 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 namePanitumumab
    D.3.2Product code AMG954
    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.3.9.2Current sponsor codeAMG954
    D.3.9.3Other descriptive namePanitumumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Patients with metastatic colorectal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To estimate the effects of KRAS mutation status (wild-type versus mutant) on objective response rate and other measures of efficacy for subjects treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5- flurouracil ( 5- FU) and leucovorin ( FOLFIRI) as 1st- line chemotherapy for subjects with metastatic colorectal cancer ( mCRC).
    E.2.2Secondary objectives of the trial
    To describe the safety profile of this combination therapy in the 1st- line setting including the incidence of AE’s and significant changes in laboratory parameters.

    Exploratory objectives:

    To explore measures of patient reported outcomes (PRO), healthcare resource utilisation and any integument and eye toxicity management scheme
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible to participate in the study if they meet all of the criteria listed below.
    1. Ethical
    Competent to comprehend, sign, and date an IEC-approved informed consent form.

    2. Demographic
    Of either gender and aged 18 years or more.

    3. Disease-related
    •Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
    •Measurable disease according to modified RECIST guidelines. All sites of disease must have been evaluated within 28 days of initiating study treatment, and diagnosed by the investigator.
    •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
    •Have available paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour.

    4. Laboratory
    -Haematologic function, as follows (within seven days prior to initiating study treatment):
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
    • Platelet count ≥100 x 109/L.
    • Haemoglobin ≥10 g/dL.

    -Renal function, as follows (within seven days prior to initiating study treatment):
    • Creatinine ≤1.5 mg/dL.

    -Hepatic function, as follows (within seven days prior to initiating study treatment):
    • Aspartate aminotransferase (AST) ≤3 x ULN (if liver metastases ≤ 5 x ULN).
    • Alanine aminotransferase (ALT) ≤3 x ULN (if liver metastases ≤ 5 x ULN).
    • Bilirubin ≤ 2 x ULN.

    -Metabolic function, as follows (within seven days prior to initiating study treatment):
    • Magnesium ≥ lower limit of normal.
    • Calcium ≥ lower limit of normal.
    E.4Principal exclusion criteria
    Any patient exhibiting any of the criteria listed below will be excluded from the study:
    1. Disease Related
    • Central nervous system metastases (Exception: subjects who have been treated, have asymptomatic central nervous system metastases, and have been off steroids for at least 30 days before initiating study treatment are eligible).

    2. Therapies
    • Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.

    • Prior anti-EGFr antibody therapy (e.g.: cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib).

    • Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.

    3. General
    • Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.

    • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.

    • Treatment for systemic infection within 14 days before initiating study treatment.

    • Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).

    • History of Gilbert’s syndrome or dihydropyrimidine deficiency.

    • History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.

    • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.

    • Any co-morbid disease that would increase risk of toxicity.

    • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.

    • Any investigational agent within 30 days before initiation of study treatment.

    • Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.

    • Subject who is pregnant or breast-feeding.

    • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (e.g. diaphragm plus condom) during the course of the study and for six months after the last study drug administration for women, and one month for men.

    • Subject unwilling or unable to comply with study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR): Incidence of either a confirmed complete or
    partial response; subjects prematurely discontinuing without a post-baseline
    tumour response assessment or subjects who do not meet the criteria for an
    objective response by the analysis data cut-off date will be considered
    non-responders.
    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 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) 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.8.3 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2007-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-12
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