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    Summary
    EudraCT Number:2006-003784-32
    Sponsor's Protocol Code Number:20050201
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-10
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-003784-32
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial
    of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced
    Non-small Cell Lung Cancer
    A.4.1Sponsor's protocol code number20050201
    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 706
    D.3.2Product code AMG 706
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG 706
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with unresectable stage IIIB with pericardial or pleural effusion or stage IV or recurrent Non Small Cell Lung Cancer (NSCLC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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
    To determine if treatment with AMG 706 in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced NSCLC.
    E.2.2Secondary objectives of the trial
    • To evaluate progression-free-survival time, objective tumor response rate (only in
    subjects with measurable disease) and duration of response.
    • To evaluate the safety and tolerability of AMG 706 in combination with paclitaxel
    and carboplatin compared to placebo in combination with paclitaxel and carboplatin.
    • To evaluate the pharmacokinetics (Cmin and Cmax) of AMG 706 when administered
    with paclitaxel and carboplatin (in approximately 250 subjects at selected centers).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed (cytological specimens obtained by bronchial washing or
    brushing, or fine-needle aspiration are acceptable), unresectable stage IIIB with
    pericardial or pleural effusion or stage IV or recurrent NSCLC. Evaluation of
    effusions (ie, with cytology) is not required if diagnosis of NSCLC has been otherwise histologically confirmed.
    • Measurable or non-measurable disease per modified RECIST criteria
    • ECOG performance status of 0 or 1
    • Life expectancy of ≥ 3 months as documented by the investigator.
    • Men or women aged ≥ 18 years old.
    • Hematological function, as follows:
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L
    - Hemoglobin ≥ 9 g/dL
    • Renal function, as follows:
    - Creatinine clearance > 40 mL/min (calculated by Cockcroft-Gault formula)
    - Urinary protein quantitative value of ≤ 30 mg in urinalysis or ≤ 1+ on dipstick unless quantitative protein is < 500 mg in a 24-hour urine sample
    • Hepatic function, as follows:
    - Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) OR
    AST < 5 x ULN if liver metastases are present
    - Alanine aminotransferase (ALT) ≤ 2.5 x ULN OR ALT < 5 x ULN if liver metastases are present
    - Alkaline phosphatase ≤ 2.0 x ULN OR alkaline phosphatase < 5 x ULN if liver or bone metastases are present
    - Total bilirubin < 1.5 x ULN OR total bilirubin < 3 X ULN if subject has UGT1A1 promoter polymorphism (ie, Gilbert syndrome) confirmed by genotyping or Invader® UGT1A1 Molecular Assay prior to randomization
    • Partial thromboplastin (PTT) ≤ 1 x ULN and international normalized ratio (INR)
    ≤ 1.5 x ULN.
    • Ability to take oral medications.
    • Competency to give written informed consent.
    • Able to start protocol directed therapy within 7 days from date of randomization.
    E.4Principal exclusion criteria
    • Untreated or symptomatic central nervous system metastases. Subjects with a
    history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the subject is clinically stable and is off corticosteroids for at least 2 weeks prior to randomization.
    • Prior chemotherapy as follows:
    - Any prior chemotherapy for advanced NSCLC
    - Any prior adjuvant chemotherapy for NSCLC within 52 weeks prior to randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted
    - Any prior chemoradiation for locally advanced stage III disease
    • Central (chest) radiation therapy within 28 days prior to randomization, radiation
    therapy within 14 days prior to randomization for peripheral lesions.
    • History of pulmonary hemorrhage or gross hemoptysis (approximately 3 mL of bright red blood or more) within 6 months prior to randomization.
    • Prior targeted therapies, including but not limited to:
    - AMG 706, inhibitors of VEGF (eg, SU5416, SU6668, ZD6474, SU11248, PTK787, AZD2171, AEE-788, sorafenib, bevacizumab), or EGFr (eg, cetuximab, gefitinib, erlotinib).
    • Known history of allergy or hypersensitivity reaction to paclitaxel or carboplatin.
    • Any anticoagulation therapy within 7 days prior to randomization. The use of low-dose warfarin [≤ 2 mg daily] or low molecular weight heparin or heparin flushes for prophylaxis against central venous catheter thrombosis is allowed.
    • History of arterial or venous thrombosis within 12 months prior to randomization.
    • History of bleeding diathesis or bleeding within 14 days prior to randomization.
    • Peripheral neuropathy > grade 1 per Common Terminology Criteria for Adverse
    Events (CTCAE) Version 3.0.
    • Clinically significant cardiac disease within 12 months of randomization, including
    myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, or ongoing arrhythmias requiring medication.
    • History of other primary cancer unless:
    o Curatively resected non-melanomatous skin cancer
    o Curatively treated cervical carcinoma in situ
    o Other primary solid tumor curatively treated with no known active disease
    present and no curative treatment administered for the last 3 years
    • Any kind of disorder that compromises the ability of the subject to comply with
    the study procedures.
    • Open wound, ulcer or fracture.
    • Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg.
    Antihypertensive medications are allowed if the subject is stable on their current
    dose at the time of randomization.
    • Surgery:
    - Major surgical procedures within 28 days prior to randomization
    - Minor surgical procedures within 14 days prior to randomization
    - Failure to recover from prior surgery
    - Placement of a central venous access device (including ports and tunneled or non-tunneled catheters) within 7 days prior to randomization
    - Planned elective surgery while on study treatment
    - Core needle biopsy within 7 days prior to randomization
    • Not recovered from all previous therapies (ie, radiation, surgery and medications). Adverse events related to previous therapies must be CTCAE grade ≤ 1 at screening or returned to the subject’s baseline prior to their most recent previous therapy.
    • Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization.
    • Pregnant (eg, positive HCG test-serum or urine) or breast feeding woman.
    • Any subject not consenting to use adequate contraceptive precautions
    (eg, hormonal, barrier or abstinence) during the course of the study and for 6 months after the last treatment.
    • Known to be human immunodeficiency virus (HIV), hepatitis B surface antigen or
    hepatitis C positive.
    • Known chronic hepatitis.
    • Active infection requiring systemic treatment or any uncontrolled infection
    ≤ 14 days prior to randomization.
    • History of any medical or psychiatric condition or laboratory abnormality that in
    the opinion of the investigator may increase the risks associated with the study
    participation or investigational product(s) administration or may interfere with the
    interpretation of the results.
    • Previously randomized to this study.
    • Not available for follow-up assessments or unable to comply with study
    requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival time: Time from randomization to death. Subjects who have not died
    while on study or are lost to follow-up 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 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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 249
    F.4.2.2In the whole clinical trial 1240
    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 Decision2007-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-13
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