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    Summary
    EudraCT Number:2007-004722-25
    Sponsor's Protocol Code Number:20060332
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-004722-25
    A.3Full title of the trial
    A Phase 1b/2 Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code number20060332
    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 655
    D.3.2Product code AMG 655
    D.3.4Pharmaceutical form Intravenous 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 INNAMG 655
    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.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 namePanitumumab
    D.3.4Pharmaceutical form Intravenous 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 655
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typerecombinant human monoclonal antibody IgG2
    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
    Colorectal cancer (CRC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is divided into 2 parts: a phase 1b portion (part 1) and a phase 2 portion
    (part 2).

    Part 1: The primary objective of part 1 is to identify a tolerable dose of AMG 655 in
    combination with panitumumab based on the incidence of dose-limiting toxicities (DLTs)
    in subjects with metastatic colorectal cancer (mCRC).

    Part 2: The primary objective of part 2 is to evaluate stratified by KRAS status (wild-type versus mutant) the objective response rate (ORR) in subjects with mCRC treated with the combination of panitumumab and AMG 655 (tolerable dose identified in part 1).
    E.2.2Secondary objectives of the trial
    Secondary
    Part 1 and 2: To evaluate the effect of the combination of panitumumab and AMG 655
    overall and stratified by KRAS status (wild-type versus mutant) on the following
    secondary endpoints in subjects with mCRC:
    • Incidence of all adverse events (AEs) and clinical laboratory abnormalities
    • Incidence of human anti-panitumumab antibodies (HAPA) and human
    anti-AMG 655 antibodies
    • Objective response (OR)
    • Duration of response
    • Time to response
    • Disease control rate (includes complete response [CR] and partial response
    [PR], or stable disease [SD])
    • Progression-free survival (PFS)
    • Overall survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria

    Disease Related
    - Histologically or cytologically confirmed metastatic adenocarcinoma of the
    colon or rectum
    - Radiographically documented disease progression per modified RECIST
    during or following treatment with fluoropyrimidine, irinotecan, and/or
    oxaliplatin chemotherapy for mCRC. Progressive disease must be
    documented during or ≤ 6 months after the last dose of the most recent
    chemotherapy regimen prior to enrollment
    - At least 1 uni-dimensionally measurable lesion measuring ≥ 20 mm in one
    dimension per modified RECIST (Appendix D). Lesion must not be chosen
    from a previously irradiated field, unless there has been documented disease
    progression in that field after irradiation and prior to enrollment. All sites of
    disease must be evaluated.
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - Available archived paraffin-embedded tumor tissue from the primary tumor or
    metastasis for submission to the central laboratory (see Section 7.7)

    Demographic
    - Man or woman ≥ 18 years of age at the time of enrollment

    Laboratory (performed ≤ 7 days before enrollment)
    - Hematologic function within the following limits:
    - Absolute neutrophil count (ANC) > 1.0 x 109 cells/L
    - Platelets ≥ 100 x 109/L
    - Renal function within the following limits:
    - Creatinine < 2.0 mg/dL
    - Hepatic function within the following limits:
    - Aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if liver
    metastases)
    - Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver
    metastases)
    - Bilirubin ≤ 2 x ULN
    - Metabolic function within the following limits:
    - Amylase ≤ 2 x ULN
    - Lipase ≤ 2 x ULN
    - Magnesium ≥ lower limit of normal
    - Negative pregnancy test ≤ 72 hours before enrollment (for woman of
    childbearing potential only)

    Medications
    - Subject must have received 1, 2, or 3 prior chemotherapy regimens for
    mCRC

    Ethical
    - Competent to comprehend, sign, and date the IEC/IRB approved written
    informed consent
    E.4Principal exclusion criteria
    Disease Related
    - History of other primary cancer, unless:
    - Curatively resected non-melanomatous skin cancer
    - Curatively treated cervical carcinoma in situ
    - Other primary solid tumor curatively treated with no known active disease
    present and no treatment administered for ≥ 5 years before enrollment

    Medications
    - Prior treatment with anti-EGFr inhibitors (eg, cetuximab, erlotinib, gefitinib),
    unless treatment was received in the adjuvant setting ≥ 6 months before
    enrollment
    - Use of systemic chemotherapy and radiotherapy ≤ 30 days before enrollment
    - Use of prior anti-tumor therapies with a short serum half-life (less than
    1 week) including prior experimental agents or approved anti-tumor small
    molecules ≤ 30 days before enrollment
    - Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab)
    including prior experimental or approved protein/antibodies ≤ 42 days before
    enrollment
    - Any investigational agent or therapy ≤ 30 days before enrollment
    - Known allergy or hypersensitivity to any component of panitumumab and/or
    AMG 655

    General
    - History of or known presence of central nervous system (CNS) metastases
    - History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or
    evidence of interstitial lung disease on baseline chest computerized
    tomography (CT) scan
    - Clinically significant cardiovascular disease (including myocardial infarction,
    unstable angina, symptomatic congestive heart failure, serious uncontrolled
    cardiac arrhythmia) ≤ 1 year before enrollment
    - Active inflammatory bowel disease or other active bowel disease causing
    chronic diarrhea (defined as ≥ CTC grade 2 [CTCAE version 3.0])
    - Known positive test for human immunodeficiency virus (HIV) infection,
    hepatitis C virus, acute or chronic hepatitis B infection
    - Any co-morbid disease or condition that could increase the risk of toxicity
    (eg, significant ascites, significant pleural effusion)
    - Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any
    medical condition that may interfere with the interpretation of the study results
    - Major surgical procedure (requiring general anesthesia) ≤ 28 days or minor
    surgical procedure (excluding central venous catheter placement) ≤ 14 days
    before enrollment. Subjects must have recovered from surgery related toxicities.
    - Other investigational procedures are excluded
    - Subject is currently pregnant or breast feeding
    - Man or woman of childbearing potential who is not willing to use adequate
    contraceptive precautions during treatment and for 6 months (for women) or
    1 month (for men) after the last investigational product administration.
    Adequate contraceptive precautions includes double barrier contraceptive
    methods (eg, diaphragm and condom) or abstinence.
    - Previously enrolled into this study
    - Subject unwilling or unable to comply with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 - Dose-limiting Toxicity (DLT): Incidence of selected adverse events and
    laboratory abnormalities as defined in Section 6.6 of the Protocol.

    Part 2 - Overall Objective Response (OR): The incidence during the treatment phase of either a confirmed CR or PR per modified RECIST criteria (responder). A confirmed CR requires 2 assessments of CR at least 28 days apart. A confirmed PR requires
    2 assessments at least 28 days apart of PR or CR. All subjects that do not meet the
    criteria for an objective response by the analysis cutoff date will be considered nonresponders.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    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 death. This has been estimated to be no more than 2 years after the last subject is enrolled into the study.
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 65
    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 Decision2008-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-04
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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
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