Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-023978-39
    Sponsor's Protocol Code Number:20080261
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-13
    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 number2010-023978-39
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the
    Pancreas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ganitumab in Locally Advanced Unresectable Adenocarcinma of the Pancreas
    A.4.1Sponsor's protocol code number20080261
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01318642
    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 Information – Clinical
    B.5.3 Address:
    B.5.3.1Street Address240 Cambridge Science Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 OWD
    B.5.3.4CountryUnited Kingdom
    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 nameGanitumab (AMG 479)
    D.3.2Product code AMG 479
    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 INNGanitumab
    D.3.9.2Current sponsor codeAMG 479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    Locally advanced adenocarcinoma of the pancreas
    E.1.1.1Medical condition in easily understood language
    Adenocarcinoma Pancreas
    Locally Advanced
    Unresectable
    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 10033606
    E.1.2Term Pancreatic cancer non-resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 relative treatment effect of AMG 479 in combination with
    gemcitabine compared to placebo in combination with gemcitabine as measured by the hazard ratio for progression-free survival (PFS) in subjects with locally advanced adenocarcinoma of the pancreas
    E.2.2Secondary objectives of the trial
    To evaluate overall survival (OS)
    To evaluate the PFS and OS rates at 3, 6, 9, 12, 18, & 24 months
    To evaluate objective response rate, time to progression, duration of response and disease control rate (partial response [PR] + complete response [CR] + stable disease [SD]) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    To evaluate subject incidence of adverse events, significant laboratory abnormalities & immunogenicity
    To evaluate AMG 479 dose intensity, dose exposure and pharmacokinetic (PK) parameters & to evaluate relationships between AMG 479 exposure measures & selected safety and efficacy measures
    To evaluate gemcitabine dose intensity & dose exposure
    To evaluate patient reported outcomes as measured by the FACT Hepatobiliary Questionnaire – Hepatobiliary subscale (FACT-Hep HS)
    To evaluate outcomes (PFS & OS) with respect to biomarker enrichment status defined by an analysis of serum biomarkers in metastatic pancreatic cancer (Study 20060540)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    If the subject signs the additional optional pharmacogenetic informed consent, DNA will be used for exploratory pharmacogenetic analyses. These analyses differ from the above blood and tumor analyses
    because they focus on evaluation of the different heritable gene forms in DNA that may influence the different responses subjects have to a study treatment. The goals of exploratory studies include the use of genetic markers to help in the investigation of cancer and to identify persons who may have the best possible response to AMG 479. To study the effects of human heritable genetic variation on investigational product response, we plan to conduct exploratory pharmacogenetic studies as an optional part of this study. No additional blood samples will be collected for this part of the study; however, for those subjects that consent to participate in optional PG studies, DNA will be extracted from the cell pellet left-over after biomarker plasma preparation.
    E.3Principal inclusion criteria
    Disease Related
    Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
    Radiologically measurable and/or non-measurable disease as defined by
    RECIST version 1.1 Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
    Demographic
    Men or women ≥ 18 years of age
    Ethical
    Before any protocol specified procedure is performed, the appropriate approved written informed consent must be obtained by the subject or the subject’s legally acceptable representative
    Laboratory
    Adequate organ function as evidenced by the following laboratory studies within 14 days before randomization:
    Hemoglobin ≥ 9 g/dL
    Absolute neutrophil count ≥ 1.5 x 109/L
    Platelet count ≥ 100 x 109/L (and no platelet transfusion within 14 days prior to the performance of the platelet count)
    Partial thromboplastin (aPTT or PTT) ≤ 1.3 x upper limit of normal (ULN) and international normalization ratio (INR) ≤ 1.5, unless subject is on anti-coagulation therapy. Subjects on therapeutic anti-coagulation are eligible if there is no bleeding and they are on a stable dose of anticoagulation therapy (eg, warfarin with an INR of 2 to 3 within 7 days before randomization)
    Calculated creatinine clearance ≥ 40 mL/minute calculated by Cockcroft-Gault formula
    Amylase ≤ 2.0 x ULN
    Blood glucose level ≤ 160 mg/dL (8.9 mmol/L). Subjects with a non-fasting blood glucose > 160 mg/dL (8.9 mmol/L) must have a fasting blood glucose ≤ 160 mg/dL (8.9 mmol/L) in order to be eligible
    Total bilirubin ≤ 2.0 x ULN
    Aspartate aminotransferase (AST) and alanine amino transferase
    (ALT) ≤ 2.5 x ULN
    General
    Plan to begin protocol specified therapy within 7 days of randomization
    Plan to be treated on protocol specified therapy until disease progression, withdrawal of consent or intolerable toxicity
    E.4Principal exclusion criteria
    Disease Related
    Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma,
    sarcoma, etc), adenocarcinoma originating from biliary tree or
    cystadenocarcinoma
    Early (stage I) or metastatic (stage IV) disease
    External biliary drain
    Any prior or synchronous malignancy, except:
    • Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician
    • Adequately treated non-melanoma 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
    Other Medical Conditions
    Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg, unstable angina, congestive heart failure [New York Heart Association(NYHA) > Class II]) within 6 months before randomization
    History of any medical condition that in the opinion of the investigator, may increase the risks associated with study participation or protocol specified therapy or may interfere with the conduct of the study or interpretation of study results
    Major surgical procedure within 30 days before randomization or not yet recovered from prior major surgery. Major surgery is defined within this protocol as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy)
    Minor surgical procedures within 7 days before randomization or not yet
    recovered from prior minor surgery; although placement of central venous access device, fine needle aspiration or endoscopic biliary stent ≥ 1 day before randomization is acceptable
    Known positive test for human immunodeficiency virus or hepatitis C or acute or chronic hepatitis B infection
    Any co-morbid disease that would increase the risk of toxicity
    Medications or Other Treatments
    Currently treated or previously treated with biologic, small molecule,
    immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
    Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
    Recent infection requiring a course of systemic anti-infectives that was
    completed within 7 days before randomization (with the exception of
    uncomplicated urinary tract infection)
    General
    Subject is continuing to receive other investigational agent(s) or subject has not yet completed at least 30 days (before randomization) since ending other investigational device or drug study(s)
    Subject of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) 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 protocol specified therapy and for 6 months after the last dose of protocol specified therapy for women and men (including sperm donation)
    Subject has known sensitivity to any of the products to be administered during the study
    Subject was previously randomized into this study
    Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator’s knowledge
    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
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free survival (PFS). This is defined as the time from randomization to progression (per RECIST version 1.1) or death. Subjects who are alive and do not have documented disease progression per RECIST version 1.1 by the analysis data cut-off date or are lost to follow up will be censored at the last evaluable tumor assessment date. Subjects who withdraw consent to participate in the study will be censored on the date of their last evaluable tumor assessment date prior to withdrawal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is defined as the time from randomization to progression (per RECIST version 1.1) or death.
    E.5.2Secondary end point(s)
    • Overall survival (OS)
    • PFS and OS rates at the timepoints of 3, 6, 9, 12, 18, and 24 months.
    • Objective Response Rate. This is defined as the incidence rate of either a complete response (CR) or partial response (PR) per RECIST version 1.1. The RECIST version 1.1 does not require a confirmatory image in a randomized study
    • Time to disease progression (TTP) for a subject is defined as time from the date of randomization to disease progression (per RECIST v1.1)
    • Duration of response as defined as time from the date of first response (PR or CR) to disease progression (per RECIST v1.1) or death
    • Disease Control Rate as defined as the incidence rate of either a complete response (CR), or partial response (PR), or stable disease (SD) per RECIST version 1.1
    • Incidence of subject adverse events, laboratory abnormalities and
    immunogenicity
    • AMG 479 dose intensity, dose exposure and pharmacokinetic (PK) parameters
    • Gemcitabine dose intensity and dose exposure
    • Relationship between AMG 479 exposure measures and selected safety and efficacy measures
    • The area under the curve for the hepatobiliary symptoms subscale as measured by the FACT-Hep HS
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12, 18, and 24 months
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    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 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.8.2.4Number of treatment arms in the trial2
    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 EEA65
    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
    Austria
    Belgium
    Czech Republic
    Denmark
    Germany
    Hungary
    Korea, Republic of
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Taiwan
    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 be the later of the Primary Completion or when the last subject discontinues all protocol therapy and has had the opportunity to complete the safety follow-up visit. The Primary Completion is the final analysis is estimated to be 24 months after the date the last subject is randomized; however, the final analysis may occur earlier if all subjects who are under active observation (ie, have not withdrawn full consent and have a last contact date within 14 weeks) have died.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 127
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 107
    F.4.2.2In the whole clinical trial 150
    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 Decision2011-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 02:32:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA