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    Summary
    EudraCT Number:2006-006658-89
    Sponsor's Protocol Code Number:20060295
    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:2007-06-08
    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 number2006-006658-89
    A.3Full title of the trial
    A Phase 1b/2 study of AMG 655 Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
    A.4.1Sponsor's protocol code number20060295
    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.3.9.2Current sponsor codeAMG 655
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage IIIb/IV Non-Small Cell Lung 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 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1 (Phase 1b): To determine the maximum tolerated dose up to a
    target dose of 15 mg/kg of AMG 655 that can be administered in
    combination with paclitaxel/carboplatin

    Part 2 (Phase 2): To estimate the efficacy of AMG 655 as assessed by progression free survival time (at two doses selected in part 1) in combination with paclitaxel/carboplatin
    E.2.2Secondary objectives of the trial
    Part 1:
    To evaluate the safety and tolerability of escalating doses of AMG 655 in
    combination with paclitaxel/carboplatin
    To evaluate parameters of clinical benefit as measured by objective
    response rate, duration of response, time-to-response, progression-free
    survival and overall survival
    To evaluate the pharmacokinetics of AMG 655
    To evaluate anti-AMG 655 antibody formation

    Part 2:
    To estimate the clinical benefit of AMG 655 in combination with
    paclitaxel/carboplatin as measured by overall objective response rate,
    duration of response, time-to-response and overall survival
    To evaluate the safety and tolerability of AMG 655 in combination with
    paclitaxel/carboplatin
    To evaluate the pharmacokinetics of AMG 655
    To evaluate anti-AMG 655 antibody formation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease Related

    • Histologically or cytologically confirmed non-small cell lung cancer. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the subject will be ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
    • Subjects must have advanced non-small cell lung cancer defined as stage IIIB
    with malignant pleural effusion or stage IV or recurrent disease (recurrent
    disease is defined as documented disease progression following complete
    surgical resection for stage I or II disease). Subjects with non-measurable but
    evaluable disease can be included in the study
    • Planning to receive up to 6 cycles of chemotherapy
    • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

    Demographic

    • Men or women ≥ 18 years of age

    Ethical

    • Before any study specific procedure is performed, the appropriate approved written
    informed consent must be obtained

    Laboratory

    The following results must be obtained within 7 days before
    enrollment/randomization unless indicated otherwise:
    • Hematological function as follows:
    − Hemoglobin ≥ 9 g/dL
    − Absolute neutrophil count ≥ 1.5 x 109/L
    − Platelet count ≥ 100 x 109/L (without a transfusion ≤ 14 days prior to enrollment or randomization)
    • Renal function, as follows:
    − Calculated creatinine clearance ≥ 40 mL/minute
    • Hepatic function, as follows:
    − Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN
    OR AST or ALT ≤ 5.0 x ULN if clearly attributable to liver metastasis
    − Total bilirubin ≤ 1.5 x ULN
    − Alkaline phosphatase ≤ 2.0 x ULN OR alkaline phosphatase ≤ 5 x ULN if liver or bone metastases are present
    • Partial thromboplastin (PTT) ≤ 1.2 x ULN and international normalized ratio (INR)
    ≤ 1.5, unless subject is on anti-coagulation therapy. Subjects on therapeutic anticoagulation
    are eligible if there is no bleeding and they are on a stable dose of
    anticoagulation therapy (eg, on warfarin with an INR of 2 to 3) for at least 14 days
    before enrollment/randomization
    • Amylase ≤ 2 x ULN
    • Lipase ≤ 2 x ULN

    General
    • Plan to begin protocol specific therapy ≤ 7 days prior to enrollment/randomization
    E.4Principal exclusion criteria
    Disease Related

    • Untreated or symptomatic central nervous system metastases.
    − Subjects with a history of CNS metastases that are both definitively
    treated and stably controlled are eligible if all of the following apply:
    1)definitive therapy has been administered (surgery and/or radiation
    therapy); 2) there is no additional treatment planned for brain
    metastases; 3) the subject is clinically stable; 4) the subject is off
    corticosteroids or on a stable dose of corticosteroids for at least 14
    days prior to enrollment/randomization•
    • Prior chemotherapy as follows:
    − Any prior chemotherapy for advanced non-small cell lung cancer
    − Any prior adjuvant or neo-adjuvant chemotherapy for non-small cell lung
    cancer ≤ 52 weeks prior to enrollment/randomization. Adjuvant or neoadjuvant
    chemotherapy completed > 52 weeks prior to randomization is
    permitted.
    − Any prior chemoradiation for non-small cell lung cancer.
    • Central (chest) radiation therapy ≤ 28 days prior to randomization, radiation therapy for peripheral lesions ≤ 14 days prior to enrollment/randomization
    • A history of other malignancies (except: curatively treated non-melanoma skin cancer, in-situ cancer of the cervix, or other in situ cancer with similarly favorable prognosis) unless treated with curative intent, with no treatment administered and without evidence of disease for ≥ 3 years
    • Other abnormal medical conditions
    • Documented myocardial infarction or unstable/uncontrolled cardiac condition (eg,
    unstable angina, congestive heart failure [New York Heart Association > Class II])
    ≤ 52 weeks prior to enrollment/randomization
    • History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders ≤ 28 days prior to enrollment/randomization
    • History of any medical or psychiatric condition or addictive disorder, or laboratory
    abnormality that in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
    • Major surgical procedure ≤ 30 days prior to enrollment/randomization or not yet
    recovered from prior major surgery
    • Minor surgical procedure ≤ 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
    • Known positive test for human immunodeficiency virus, hepatitis C virus or acute or
    chronic hepatitis B infection
    • Any co-morbid disease that would increase the risk of toxicity

    Medications and other treatments

    • Currently treated or previously treated with biologic, small molecule, immunotherapy, or other agents to treat advanced non-small cell lung cancer
    • Recent infection requiring a course of systemic anti-infectives that was completed
    ≤ 7 days before enrollment/randomization (with the exception of uncomplicated urinary tract infection)
    • Yellow fever vaccination within 30 days of randomization

    General

    • Subject is not able to tolerate intravenous drug infusions
    • Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
    • Subject of child-bearing potential is evidently pregnant or is breast feeding
    • Woman or man with partner of childbearing potential not consenting to use
    adequate contraceptive precautions ie double barrier contraceptive methods (eg
    diaphragm plus condom), or abstinence during the course of the study and for 3
    months after the last study drug administration for women, and 6 months for men
    • Subject has known sensitivity to any of the products to be administered during the study
    • Subject was previously enrolled/randomized in this study
    • Subject will not be available for follow-up assessment
    • 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
    • Subject unwilling or unable to comply with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities

    Part 2: Progression free survival
    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 Yes
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b/2 study
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 will occur when all subjects have died, completed the treatment period or long-term follow-up (up until 36 months from the date that the last subject was randomized), whichever is later.
    The end of study for a subject is defined as 36 months from the last subject randomized or death, whichever occurs first. The end of study visit for a subject is planned for approximately 60 days after a subject discontinues investigational product administration.
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 184
    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 Decision2007-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
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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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