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    Summary
    EudraCT Number:2006-003785-33
    Sponsor's Protocol Code Number:20060100
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-003785-33
    A.3Full title of the trial
    A Global, Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Renal Cell Carcinoma
    A.4.1Sponsor's protocol code number20060100
    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 nameAMG 102
    D.3.2Product code AMG 102
    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 codeAMG 102
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    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
    Advanced Renal Cell Carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess objective response rate in subjects with advanced renal cell
    carcinoma receiving AMG 102 treatment.
    E.2.2Secondary objectives of the trial
    • To estimate the overall survival and progression-free survival rates in this population
    • To assess duration of response and time to response in this population
    • To assess the pharmacokinetics of AMG 102 in subjects with advanced renal cell carcinoma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - documented histologically confirmed advanced or metastatic renal cell
    carcinoma with the primary tumor in place or following nephrectomy
    - measurable disease, defined as ≥ 1 unidimensionally measurable lesion
    ≥ 20 mm by conventional techniques (CT or MRI) or ≥ 10 mm by spiral CT
    scan
    - no more than 3 relapses (or prior systememic treatments)
    - unable or ineligibile to receive or failed prior therapy with vascular
    endothelial growth factor (VEGF) binding agents or VEGF receptor
    tyrosine kinase inhibitors or other multi-kinase inhibitors
    - tissue blocks or tissue sections from initial or upon diagnosis of advanced metastatic disease are available for submission to the central laboratory within approximately 4 weeks after enrollment or approval is granted by the sponsor (upon receipt of justification why the sample is not available)
    -age≥18 years
    - EGOC performance status of 0-2
    - haemoglobin concentration ≥9g/dL
    - absolute neutrophil count ≥1.5 x 109/L
    -platelet count ≥100 x 109/L
    -corrected serum calcium less than or equal to 10 mg/dL
    - either serum creatinine <2.0 x ULN or cratinine clearance >40 mL/min
    -alanine aminotransferase less than or equal to 2.5 x ULN or > 5.0 x ULN if the subject has documented liver metastasis or primary hepatic neoplasm.
    -serum total bilirubin less than or equal to 2.5 x ULN.
    -before any study-specific procedure, the appropriate written informed consent must be obtained
    E.4Principal exclusion criteria
    Disease Related:
    - active brain metastases; brain metastases allowed provided they have been
    treated with surgery and/or radiation therapy and show no evidence of
    progression on cerebral CT or MRI scan 2 months following surgery and/or
    radiation therapy
    - concurrent severe and/or uncontrolled medical disease (eg, uncontrolled
    diabetes, congestive cardiac failure, myocardial infarction within 6 months
    before enrollment) that could compromise participation in the study
    - documented history of human immunodeficiency virus infection
    - documented history of viral chronic hepatitis
    Medications:
    - received biologic, small molecule, immunotherapy, chemotherapy,
    radiotherapy or other agents to treat renal cancer within 4 weeks before
    enrollment
    - treated previously with c-Met or HGF targeted therapy
    - concurrent or prior (within 7 days of enrollment ) anticoagulation therapy,
    unless:
    Subject has an INR value of between 2.0 and 3.0 while on a stable dose of a coumarin-type anticoagulant for at least 30 days prior to enrollment, and

    Subject does not have a history of clinically significant bleeding or bruising while on anticoagulants

    - concurrent use of hormones or other chemotherapeutic agents except for
    steroids given for adrenal failure and hormones administered for nondisease-
    related conditions (eg, insulin for diabetes); except for non-cancer
    reasons.
    - concurrent palliative or therapeutic radiation therapy
    General:
    - currently enrolled in or has not yet completed at least 30 days since ending
    other investigational device or therapy, or subject is receiving other
    investigational agent(s)
    - active infection requiring treatment within 1 week before enrollment
    - undergone major surgery within 4 weeks before enrollment or recovering
    from prior surgery
    - past or current history of another neoplasm, except for curatively treated nonmelanoma
    skin cancer, carcinoma in situ of the cervix and other primary solid
    cancer with no known active disease present and no curative treatment
    administered for the last 3 years
    - known allergy or sensitivity to any of the excipients in the investigational
    product to be administered
    - pregnant or is breast feeding
    - not consenting to use adequate contraceptive precautions during the course
    of the study and for 6 months after the last administration of investigational
    product
    - female subjects who are post menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this requirement
    - previously treated with AMG 102
    - previously enrolled into this study
    - will not be available for follow-up assessments
    - has other disorders that compromises the ability of the subject to give written
    informed consent and/or comply with study procedures
    - unable to begin protocol specified treatment within 3 days after enrollment
    E.5 End points
    E.5.1Primary end point(s)
    objective response rate
    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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 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
    Subjects may continue receiving investigational product until intolerable
    adverse event, lack of clinical benefit, full consent withdrawal,
    administrative decision by the investigator or the Sponsor, positive
    pregnancy report, significant protocol deviation, subject noncompliance,
    lost to follow-up or disease progression.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 80
    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 Decision2006-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
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