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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005013-76
    Sponsor's Protocol Code Number:AC15004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-03-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-005013-76
    A.3Full title of the trial
    GEM3: A double blind placebo controlled trial of a combination of methotrexate and gefitinib versus methotrexate alone as a treatment for ectopic pregnancy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GEM 3: combination methotrexate and gefitinib for the treatment of ectopic pregnancy.
    A.3.2Name or abbreviated title of the trial where available
    GEM3
    A.4.1Sponsor's protocol code numberAC15004
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN67795930
    A.5.4Other Identifiers
    Name:Ethics numberNumber:16/SS/0014
    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 SponsorACCORD office
    B.1.3.4CountryUnited Kingdom
    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 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
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian R&D Office
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointAnn Doust
    B.5.3 Address:
    B.5.3.1Street AddressRoom S7128, Simpson Centre for Reproductive Health
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4SA
    B.5.4Telephone number01312429492
    B.5.5Fax number01312422686
    B.5.6E-mailann.doust@ed.ac.uk
    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 Yes
    D.2.1.1.1Trade name Iressa
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zenica
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameIressa
    D.3.2Product code EU/1/09/526/001
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGefitinib
    D.3.9.1CAS number 184475-35-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Ectopic pregnancy
    E.1.1.1Medical condition in easily understood language
    Pregnancy growing outside of womb.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014166
    E.1.2Term Ectopic pregnancy
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a randomised controlled trial.

    To see if taking methotrexate (MTX) in combination with gefitinib is better at reducing the need for surgery against methotrexate alone in the treatment of ectopic pregnancy.


    E.2.2Secondary objectives of the trial

    To see if taking MTX in combination with gefitinib is better than methotrexate alone in reducing the need for a further dose of MTX.
    To see if it will reduce the numbers of days until the pregnancy is resolved (pre-pregnancy hormone level of <=15 iu/l which could reduce the number of visits to the hospital.
    To see if the treatment is safe to use and that women can tolerate the treatment. To see if women are happy taking the treatment.

    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    GEM 3 - Mechanistic study
    E.3Principal inclusion criteria
    MAIN STUDY

    • Clinical decision made for treatment of EP with MTX
    • Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent
    • Women 18-50 years at time of randomisation
    • Diagnosis of;
    1. definite tubal EP (extrauterine gestational sac with yolk sac and/or
    embryo, without cardiac activity on USS) or
    2. clinical decision of probable EP (extrauterine sac-like structure or
    inhomogeneous adnexal mass on USS with a background of sub optimally
    rising serum hCG concentrations)
    • Pre-treatment serum hCG level of 1000–5000 iu/l (within 1 calendar day of treatment )
    • Clinically stable
    • Haemoglobin between 100 and 165 g/L within 3 calendar days of treatment
    • Able to comply with treatment and willing to participate in follow up
    • Not participating in any other clinical trial of a medicinal product or previous participation in GEM 3 trial.

    E.4Principal exclusion criteria
    MAIN STUDY:

    • Women with a pregnancy of unknown location (PUL)
    • Breastfeeding
    • Hypersensitivity to gefitinib
    • Women with EP mass on ultrasound greater than 3.5cm
    • Women with evidence of intrauterine pregnancy
    • Evidence of significant intra-abdominal bleed on ultrasound defined by
    echogenic free fluid above the uterine fundus or surrounding ovary within1 calender day of treatment
    • Significant abdominal pain, guarding/rigidity
    • Clinically significant abnormal liver/renal/haematological indices noted
    within 3 calendar days of treatment
    • Significant pre-existing dermatological disease
    • Significant pulmonary disease
    • Significant gastrointestinal medical illness
    • Japanese ethnicity



    E.5 End points
    E.5.1Primary end point(s)
    The need for surgical intervention for treatment of EP (salpingectomy/salpingostomy by laparoscopy/laparotomy)


    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment
    E.5.2Secondary end point(s)
    SECONDARY CLINICAL OUTCOMES:
    1) Additional MTX
    2) time to hCG resolution (days) from randomisation to hCG level of ≤15 iu/l
    3) number of treatment-associated hospital visits until resolution or scheduled/emergency surgery
    4) safety/tolerability
    5) Acceptability of treatment
    6) Return to menstruation


    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months post treatment

    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 No
    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 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 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 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 concerned50
    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
    Last questionnaire received.
    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 months8
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 358
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state328
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 328
    F.4.2.2In the whole clinical trial 328
    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)
    Not applicable; the trial treatment will stop once the pregnancy has resolved. Any subsequent care will be carried as per local trust policy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-29
    P. End of Trial
    P.End of Trial StatusOngoing
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