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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-001605-42
    Sponsor's Protocol Code Number:20060317
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-001605-42
    A.3Full title of the trial
    A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with Unresectable
    Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
    A.4.1Sponsor's protocol code number20060317
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00719550
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info – Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.com
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 placeboConcentrate for solution for 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
    Unrespectable locally advanced or metastatic gastric or esophagogastric unction adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Esophagogastric Junction Adenocarcinoma
    Gastric Cancer
    Esophageal Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10017759
    E.1.2Term Gastric cancer in situ
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary

    Part 1 (phase 1b-open label):

    • To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with
    ECX.

    Part 2 (phase 2-double-blind):

    • To estimate with pre-specified precision the effect of the addition of AMG 102 to
    ECX on the progression free survival (PFS) of previously untreated subjects with
    unresectable locally advanced or metastatic gastric or esophagogastric junction
    adenocarcinoma.
    E.2.2Secondary objectives of the trial
    Secondary

    Part 1

    To evaluate the incidence of adverse events, abnormal laboratory values not defined as DLTs, and anti-AMG 102 antibody formation.
    To evaluate the PK of AMG 102 (Cmax and Cmin).

    Part 2

    To evaluate the effect of the addition of AMG 102 to ECX on OS, response rates, time to response, duration of response, disease control rates, incidence of adverse events and laboratory abnormalities.
    To evaluate the PK (Cmax and Cmin) of AMG 102, and estimate the impact of
    co-administration of AMG 102 to the PK of epirubicin and cisplatin in a sub-group of
    subjects at selected sites outside of Europe/Asia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria

    4.1.1 Disease related
    • Pathologically confirmed unresectable locally advanced or metastatic gastric or
    esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus
    within 5 cm of the EGJ are eligible
    • ECOG performance status 0 or 1
    • Life expectancy ≥ 3 months
    4.1.2 Demographic
    • Male or female ≥ 18 years of age
    4.1.3 Ethical
    • Before any study-specific procedure, the appropriate written informed consent
    must be obtained (see Section 12.1)
    4.1.4 Laboratory
    • Hemoglobin ≥ 9 g/dL (can be post-transfusion)
    • Absolute neutrophil count ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L (without transfusion within 14 days before enrollment
    or randomization)
    • Creatinine clearance ≥ 60 mL/minute (calculated or measured)
    • Aspartate aminotransferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x
    ULN (OR AST and ALT ≤ 5.0 x ULN in the presence of liver metastasis)
    • Total bilirubin ≤ 1.5x ULN
    • Partial thromboplastin time (PTT) ≤ 1.5 x ULN and international normalized ratio
    (INR) ≤ ULN
    4.1.5 General
    • Plan to begin protocol specific therapy within 7 days after enrollment or
    randomization
    • Able to tolerate infusions and take oral medications
    E.4Principal exclusion criteria
    Exclusion Criteria

    4.2.1 Disease Related
    • Previous systemic therapy (chemotherapy or biologic therapy) for locally
    advanced or metastatic gastric or esophagogastric adenocarcinoma
    • Less than 6 months have elapsed from completion of prior neoadjuvant or
    adjuvant chemotherapy or chemoradiotherapy. Patients previously treated with
    anthracyclines must not exceed total cumulative dose of epirubicin of 900 mg/m2
    (or equivalent thereof, if a different anthracycline has been administered in the
    past) including doses to be administered in this trial.
    • Any prior or synchronous malignancy (except for non-melanomatous skin cancer
    or in situ cervical cancer) other than the study disease, unless treated with
    curative intent and having completed all therapy with no evidence of disease ≤ 5
    years before enrollment or randomization
    • Known peripheral neuropathy > grade 1
    • Known dihydropyrimidine dehydrogenase deficiency (DPD)
    • Any clinically significant medical condition other than cancer, including cardiovascular disease or chronic obstructive pulmonary disease (COPD), which in the opinion of the investigator would interfere with the safe delivery of study
    treatment or increase risk of toxicity
    • History of any medical condition 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 before enrollment or randomization or not yet
    recovered from prior major surgery
    • Minor surgery (e,g. catheter or gastrostomy tube placement) ≤14 days before
    enrollment or randomization or not yet recovered from prior minor surgery;
    although placement of central venous access device, fine needle aspiration,
    thoracentesis, endoscopic biliary stent or paracentesis ≥ 1 day before enrollment
    or randomization is acceptable
    • Subjects with resectable disease or suitable for definitive chemoradiation
    • Plans for surgical resection based on response to protocol therapy
    • Subjects who have persistent gastric outlet obstruction, complete dysphagia or
    are dependent upon jejunostomy for feeding.
    • Tumors of squamous cell histology
    • Treatment with radiotherapy ≤ 14 days before enrollment or randomization
    • Known central nervous system metastases
    • Clinically significant upper gastro-intestinal bleeding < 30 days prior to enrollment
    or randomization
    4.2.2 Cardiac
    • LVEF < 50% as determined by either MUGA scan or ECHO
    • Clinically significant (i.e. active) cardiac disease or myocardial infarction within
    the last 12 months before enrollment or randomization. Patients with any history
    of clinically significant cardiac failure are excluded from study entry
    4.2.3 Other abnormal medical conditions
    • Serious or non-healing wound
    • Known positive test for HIV, hepatitis C, chronic or active hepatitis B
    • Presence of peripheral edema > Grade 2
    • Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:

    Part 1

    • The incidence of adverse events defined as DLTs

    Part 2

    • PFS

    Secondary Endpoints:

    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1 - throughout Paty 1

    Part 2 - time from start of study until progression
    E.5.2Secondary end point(s)
    Part 1
    • Incidence of adverse events, abnormal laboratory values not defined as DLTs, and anti-AMG 102 antibody
    • Cmax and Cmin of AMG 102 concentration

    Part 2
    • OS, objective response rate (CR and PR per RECIST with modifications) , disease control rate (CR, PR and SD per RECIST with modifications), time to response (for responders only), and duration of response (for responders only)
    • Incidence of adverse events, significant laboratory value changes from baseline and anti-AMG 102 antibody formation
    • Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin when used with or without AMG 102 in a sub-group of subjects at selected sites outside of Europe/Asia
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS: time from randomization to disease progression, symptomatic deterioration, or death.
    OS: time from randomization to death.
    Objective Response Rate: the proportion of subjects (with measurable disease at baseline) who have either confirmed complete response (CR) or confirmed partial response (PR)
    Disease Control Rate: the proportion of subjects with measurable disease at baseline who have either complete response (CR), partial response (PR), or stable disease (SD) per RECIST with modifications.
    Time to response: time from randomization to date of first response.
    Duration of Response: time from first objective response to first disease progression or death due to progressive disease.
    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) 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
    Dose De-escalation
    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.8.2.4Number of treatment arms in the trial3
    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 EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Greece
    India
    Italy
    Poland
    Russian Federation
    Singapore
    Spain
    United Kingdom
    United States
    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 (for a maximum of 36 months from the date that the last subject was enrolled or randomized) whichever is later. 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, whichever is earlier.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 138
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment
    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 Decision2008-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-19
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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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