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    The EU Clinical Trials Register currently displays   44236   clinical trials with a EudraCT protocol, of which   7337   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:2015-004370-14
    Sponsor's Protocol Code Number:20150930
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-20
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-004370-14
    A.3Full title of the trial
    89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211
    A.3.2Name or abbreviated title of the trial where available
    89Zr-AMG211 PET imaging study
    A.4.1Sponsor's protocol code number20150930
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointE.G.E. de Vries
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503612821
    B.5.5Fax number+31503614862
    B.5.6E-maile.g.e.de.vries@umcg.nl
    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 name89Zr-AMG211
    D.3.2Product code 89Zr-AMG211
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intrauterine use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 211
    D.3.9.2Current sponsor codeAMG 211 / MEDI-565
    D.3.9.3Other descriptive nameAMG 211
    D.3.9.4EV Substance CodeSUB130386
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.37
    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 Yes
    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 No
    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.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 nameAMG211
    D.3.2Product code AMG211
    D.3.4Pharmaceutical form 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 211
    D.3.9.2Current sponsor codeAMG 211/MEDI-565
    D.3.9.3Other descriptive nameAMG 211
    D.3.9.4EV Substance CodeSUB130386
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.37
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/refractory gastrointestinal adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Gastro-intestinal adenocarcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this imaging study is to evaluate the in vivo biodistribution (measured in SUV (Standard Uptake Values)) and quantitative radioactivity in organs of 89Zr-AMG211 in patients with relapsed/refractory gastrointestinal adenocarcinoma as assessed by PET/CT.
    o To evaluate the accumulation, distribution and localization of 89Zr-AMG211 in tumor tissue, organs and blood.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this imaging study are:
    • To evaluate the correlation between 89Zr-AMG211 tumor uptake and response to therapy.
    • Number of patients with adverse events after 89Zr-AMG211 injection as a measure of safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject may already have received AMG 211 cIV infusion
    • Subject has provided informed consent to imaging study prior to initiation of any study-specific activities/procedures
    • Male or Female ≥ 18 years of age at the time of informed consent
    • Pathologically documented, diagnosed GI adenocarcinoma (including but not limited to esophageal, gastric, small intestine, colorectal, or
    pancreatic cancers) that has failed standard treatments or for which standard curative or palliative measures do not exist or are no longer
    effective
    • At least 1 measurable tumor lesion per modified irRC
    o In case we do not find any uptake in metastatic liver lesions in the first set of patients on the 89Zr-AMG211 PET scan, than subsequent
    patients need to have at least 1 measurable tumor lesion outside the liver
    • Archival tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment
    • Adequate hematological, renal, and liver function as follows:
    o Absolute neutrophil count (ANC) > 1500/mm3 (1.5 × 109/L)
    o Platelet count > 100,000 mm3 (100 × 109/L)
    o White blood cell (WBC) count > 3 × 109/L
    o Hemoglobin > 9.0 g/dL
    o AST and ALT < 3.0 × the upper limit of normal (ULN)
    o Alkaline phosphatase (ALP) ≤ 2.5 × ULN
    o Total bilirubin (TBL) < 1.5 × ULN (unless subject has suspected Gilbert’s syndrome or extrahepatic cause by increased indirect bilirubin fraction)
    o Creatinine clearance > 50 mL/min calculated by Cockroft-Gault
    o Lipase/amylase < 1.5 x ULN
    o Prothrombin time, partial thromboplastin time, and international normalized ratio (INR) ≤ 1.5 × ULN
    • Life expectancy ≥ 3 months, in the opinion of the investigator
    • Karnofsky Performance Status ≥ 70%
    • Body weight ≥ 45 kg
    E.4Principal exclusion criteria
    • History of allergy or reaction to any component of the AMG 211 formulation
    • Malignancy other than GI adenocarcinoma requiring current therapy
    • Evidence of uncontrolled systemic disease (other than GI adenocarcinoma)
    • Active infection or prior use of IV antibiotics for treatment of infection within 2 weeks prior to starting therapy with AMG 211
    • Corrected QT interval (QTc) ≥ 500 milliseconds at screening
    • Hepatitis B and/or C based on the following results:
    o Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute Hepatitis B)
    o Negative HepBsAg and positive Hepatitis B core antibody: Hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable
    Hepatitis B virus DNA suggests occult Hepatitis B.
    o Positive Hepatitis C virus antibody (HepCAb) Hepatitis C virus RNA by PCR is necessary. Detectable Hepatitis C virus RNA suggests chronic Hepatitis C
    • Positive results for human immunodeficiency virus (HIV)
    • Major surgery within 28 days of study day 1
    • Prophylactic anti-infection vaccination within 1 month prior to starting therapy with AMG 211. Therapeutic vaccination for cancer or infection
    within 3 months prior to starting therapy with AMG 211.
    • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another
    investigational device or drug study. Other investigational procedures while participating in this study are excluded.
    o Exception to this criterion is the participation in Study 20130354 and all procedures related to this study.
    • Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry or not
    recovered from treatment
    • unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE), version
    4.0 grade 1 or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from anti-tumor therapy that are considered
    irreversible (defined as having been present and stable for > 6 months), may be allowed if they are not otherwise described in the exclusion criteria AND
    there is agreement to allow by both the investigator and the sponsor
    • Recent history of cardiac disease, including myocardial infarction, unstable angina pectoris, or uncontrolled arrhythmia within 6 months; or evidence of
    severe congestive heart failure with New York Heart Association severity classification > Class I within 12 weeks prior to screening
    • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above), that in the opinion of
    the investigator or sponsor would pose a risk to subject’s safety or interfere with the study evaluation, procedures, or completion
    • Clinical history of significant central nervous system (CNS) pathology (including but not limited to: history of brain metastasis, multiple occurrences of
    confusion, dementia, previous CNS infarctions, migraine headaches [within 6 months prior to starting therapy with AMG 211], seizure disorder, or
    major brain surgery)
    • History of chronic autoimmune disease, e.g., rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, or multiple sclerosis
    (with the exception of stable type 1 diabetes)
    • Males or Females of reproductive potential and unwilling to practice an acceptable method of effective birth control while on study through 30 days
    after receiving the last dose of study drug. Acceptable methods of effective birth control include:
    o sexual abstinence (males, females)
    o use of a combination of 2 acceptable methods of effective birth control including: bilateral tubal ligation (females), vasectomy (males), oral,
    transdermal, injected, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, contraceptive
    sponge with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner)
    • Females who are lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug
    • Females with a positive pregnancy test
    • Females planning to become pregnant while on study through 30 days after receiving the last dose of investigational product
    • Subject is likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to
    the best of the subject and investigator’s knowledge
    E.5 End points
    E.5.1Primary end point(s)
    • The quantitative uptake of 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value)
    89Zr-AMG211 tumor uptake and organ distribution will be scored visually and quantitatively.

    Standardized uptake value (SUV), relative uptake value (RUV) and %ID (percentage of injected dose) of 89Zr will be determined in the tumor lesions and in relevant tissues. These calculations will provide information on 89Zr-AMG211 penetration in gastrointestinal adenocarcinoma and the organ distribution.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the study we will continously monitor the obtained results. To evaluate the primary endpoint all data will be analysed when the study is ended.
    E.5.2Secondary end point(s)
    • Response to AMG 211 therapy will be analyzed in Study 20130354 according to the immune related response criteria (irRC). These results will be correlated to 89Zr-AMG211 tumor uptake data (measured in SUV).
    • Number of patients with adverse events after 89Zr-AMG211 injection as a measure of safety and tolerability. Incidence, nature and severity of adverse
    events will be measured.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will be analysed when the end of study is reached.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Imaging
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of this imaging study is defined as the date when the last scan of the last patient is performed. Following imaging scans at the end of this imaging study, patients may continue AMG 211 therapy as part of Study 20130354 protocol, for which a specific separate informed consent was signed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    Following imaging scans at the end of this imaging study, patients may continue AMG 211 therapy as part of Study 20130354 protocol, for which a specific separate informed consent was signed.
    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 Decision2016-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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