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    Summary
    EudraCT Number:2007-003573-50
    Sponsor's Protocol Code Number:20060439
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-20
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-003573-50
    A.3Full title of the trial
    A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination with AMG 386 or Placebo in Subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
    A.4.1Sponsor's protocol code number20060439
    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 386
    D.3.2Product code AMG 386
    D.3.4Pharmaceutical form Concentrate for 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.3.8INN - Proposed INNAMG 386
    D.3.9.2Current sponsor codeAMG 386
    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
    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
    Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    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 treatment effect as measured by progression free survival (PFS) of subjects receiving AMG 386 (at 2 doses) in combination with CX relative to CX/placebo
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of the combination regimen of AMG 386 with CX
    - To estimate other measures of treatment effect (objective response rate,
    duration of response, overall survival, time to progression and time to
    response)
    - To evaluate the pharmacokinetics of AMG 386 when used in combination with CX
    - To estimate the immunogenicity as assessed by the incidence of anti-AMG 386 antibody formation
    - To estimate the impact of AMG 386 on cancer-related symptoms based on
    patient reported outcomes using the QLQ-STO22
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A pharmacokinetics substudy for cisplatin and capecitabine is described in the protocol. No subjects from the EU will be enrolled in this substudy.
    E.3Principal inclusion criteria
    Disease Related
    • Histologically or cytologically confirmed adenocarcinoma of the stomach,
    gastroesophageal junction or distal esophagus with metastatic disease.
    • Subject with prior gastrectomy (total or partial) may be allowed to participate
    in the study as long as they can take oral medications and meet all other
    inclusion/exclusion criteria. Subjects may not take crushed or dissolved
    capecitabine via a feeding/gastrostomy tube.
    • Subjects who received palliative radiotherapy for the metastatic esophageal or
    gastric cancer prior to study entry may be allowed to participate in the study
    as long as all toxicities from radiotherapy have resolved and the radiotherapy
    was not to the only site of known metastatic disease.
    • Measurable or non-measurable disease per modified RECIST (Response Evaluation
    Criteria in Solid Tumor) Guidelines (please refer to Appendix G). All scans and
    x-rays used to document measurable or non-measurable disease must be
    done within 28 days prior to randomization
    Demographic
    • 18 years of age or older at the time the written informed consent is obtained
    • Subjects of child-bearing potential and sexually active must consent to the use an
    accepted and effective non-hormonal method of contraception (ie, double barrier
    method [eg, condom plus diaphragm]) from signing the informed consent through
    6 months following last administration of study drug
    General
    • Able to tolerate intravenous infusions
    • Able to swallow oral medication
    • ECOG performance status of 0 or 1 (within 14 days prior to randomization)
    • Subject plans to begin protocol directed therapy within 7 days of randomization
    Laboratory
    Adequate organ and hematological function as evidenced by the following laboratory
    studies within 14 days prior to randomization:
    • Hematological function, as follows:
    − Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    − Platelet count ≥ 75 x 109/L and ≤ 850 x 109/L
    − Hemoglobin ≥ 9 g/dL
    • Coagulation function, as follows:
    − PTT or aPTT ≤ 1.5 x ULN per institutional laboratory normal range
    − INR ≤ 1.5
    • Renal function, as follows:
    − Urinary protein quantitative value of ≤ 30 mg/dl in urinalysis or ≤ 1+ on dipstick,
    unless quantitative protein is < 1000 mg in a 24 hour urine sample
    − Creatinine clearance ≥ 50 mL/min
    Investigators may calculate creatinine clearance (CrCl) by either Cockcroft-Gault
    formula or 24 hour urine creatinine clearance.
    (140-age) x actual body weight (kg)
    CrCl (mL/min) = (x 0.85 for females)
    72 x serum creatinine (mg/dL)
    Or
    (140-age) x actual body weight (kg)
    CrCl (mL/min) = (x 0.85 for females)
    0.8136 x serum creatinine (umol/L)
    • Hepatic function, as follows:
    − Total bilirubin ≤ 1.5 x ULN
    − SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are
    present)
    E.4Principal exclusion criteria
    Disease Related
    • Prior chemotherapy for metastatic disease (1st line)
    • Less than 12 months have elapsed from completion of previous adjuvant or
    neoadjuvant chemotherapy or chemoradiotherapy
    • Subjects with persistant gastric outlet obstruction, complete dysphagia or feeding
    jejunostomy
    • Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered
    from all radiotherapy-related toxicities
    • Current or prior history of central nervous system metastases
    • History of arterial or deep venous thromboembolism within 12 months prior to
    randomization
    • History of clinically significant bleeding within 6 months prior to randomization
    • Major surgical procedure within 28 days prior to randomization
    • Minor surgical procedure, placement of central venous access device (PICC or
    peripherally inserted central catheter lines) or fine needle aspiration within 3 days
    prior to randomization
    • Subjects with a history of prior malignancy, except:
    − Malignancy treated with curative intent and with no known active disease
    present for ≥ 3 years prior to enrollment (or randomization) and felt to be at
    low risk for recurrence by treating physician
    − Adequately treated non-melanomatous skin cancer or lentigo maligna
    without evidence of disease
    − Adequately treated cervical carcinoma in situ without evidence of disease
    − Prostatic intraepithelial neoplasia without evidence of prostate cancer
    • Clinically significant cardiovascular diseases within 12 months prior to randomization,
    including myocardial infarction, unstable angina, grade 2 or greater peripheral
    vascular disease, cerebrovascular accident, transient ischemic attack, congestive
    heart failure, or arrhythmias not controlled by outpatient medication, percutaneous
    transluminal coronary angioplasty/stent
    • Non-healing wound, ulcer (including gastrointestinal) or fracture
    • Ongoing or clinically significant active infection as judged by the investigator
    • Known hypersensitivity to bacterial proteins, or any of the drugs required in this study
    • Known peripheral neuropathy ≥ Grade 1
    • Known dihydropyrimidine dehydrogenase deficiency
    • Known hypersensitivity to 5-FU/capecitabine
    • Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
    • Known active or chronic hepatitis
    Medications
    • Currently or previously treated with AMG 386, or other molecules that inhibits
    angiopoietin, or TIE-2 receptors including, but not limited to, XL-820, XL-184, or
    CVX-060/PF-4856884
    • Treatment with immune modulators such as cyclosporine or tacrolimus within
    30 days prior to randomization
    • Treatment with sorivudine or its chemically related analogues such as brivudine
    • Concurrent or prior (within 7 days prior to randomization) anticoagulation
    therapy, excluding aspirin and anti-platelet agents. The concurrent use of low
    molecular weight heparin or heparanoids or low dose warfarin (ie, ≤ 1 mg daily)
    for prophylaxis against thrombosis is acceptable while on study
    General
    • Any condition which in the investigator’s opinion makes the subject unsuitable for
    study participation
    • Not yet completed at least 30 days since ending other investigational device/drug
    trial(s), or subject is receiving other investigational treatments
    • Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding
    • Previously enrolled into this study
    • Inability to comply with protocol and/or not available for follow-up assessments
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    PFS: defined as time from date of randomization to date of disease progression (per the modified RECIST criteria) or death. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.

    Secondary:
    • Incidence of Adverse Events (AEs) and significant laboratory changes from
    baseline
    • Objective Response Rate (ORR): the incidence of either confirmed Complete
    Response (CR) or confirmed Partial Response (PR) per the modified RECIST
    criteria. A confirmed CR requires two assessments of CR at least 28 days apart.
    Two assessments at least 28 days apart of either CR or PR are required for a
    determination of PR. Subjects who do not meet the criteria for confirmed response
    by the database cutoff date are considered to be non-responders
    • Duration of Response (DOR): (only calculated for those subjects who respond)
    time from first confirmed objective response to disease progression (per the
    modified RECIST criteria). Subjects who do not meet the criteria for progression
    or who die by the database cutoff date for analysis are censored at their last
    evaluable disease assessment date
    • Overall Survival (OS): time from date of randomization to date of death. Subjects
    still alive at the database cutoff date for analysis are censored at their last contact
    date
    • Time to Progression (TTP): time from date of randomization to date of disease
    progression per the modified RECIST criteria. Subjects who do not meet the
    criteria for progression by the database cutoff date for analysis will be censored at
    their last evaluable disease assessment date
    • Time to response: time from randomization date to date of first response for
    confirmed responders. Subjects with a best response of SD by the database
    cutoff date for analysis are censored at their last evaluable disease assessment date. Non-responders with a best response of PD will be censored at the
    maximum time to a first confirmed response among all responders
    • Pharmacokinetics parameters of AMG 386 when used in combination with CX
    • Incidence of anti-AMG 386 antibody formation
    • Change in cancer-related symptoms as assessed with the QLQ-STO22
    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 Yes
    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) 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 concerned3
    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 is when all subjects have completed the treatment period or long-term follow-up (maximum 48 months from the date the last subject is randomized), whichever is later.
    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 months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-20. Yes
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 165
    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 Decision2008-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-06
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