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    Summary
    EudraCT Number:2011-001747-69
    Sponsor's Protocol Code Number:GEMII-1
    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:2011-09-28
    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 number2011-001747-69
    A.3Full title of the trial
    Combination gefitinib and methotrexate to treat ectopic pregnancies II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GEM study for ectopic pregnancy
    A.3.2Name or abbreviated title of the trial where available
    GEM for Ectopic Pregnancies II
    A.4.1Sponsor's protocol code numberGEMII-1
    A.5.4Other Identifiers
    Name:ACTRNNumber:12610000684022
    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 SponsorMonash University
    B.1.3.4CountryAustralia
    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 AddressSimpson Centre for Reproductive Health, 51 Little France Crescent
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312429492
    B.5.5Fax number01312422686
    B.5.6E-mailann.doust@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsor
    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 Yes
    D.2.1.1.1Trade name Iressa
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    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 nameGefitinib ("Iressa")
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ectopic pregnancy or pregnancy of unknown location.
    E.1.1.1Medical condition in easily understood language
    A pregnancy that is not inside the 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 14.0
    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
    We aim to show that combination therapy of gefitinib and methotrexate is more effective in the treatment of unruptured ectopic pregnancies and pregnancies of unknown location than methotrexate alone and therefore decrease the number of women requiring surgery for this condition and increase the success rate of medical treatment as well is increasing the number of women eligible for this medical management.
    E.2.2Secondary objectives of the trial
    To collect data on the efficacy of this drug combination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women aged between 18 and 45 inclusive
    2. Women with serum hCG greater than 5
    3. Women with either a mass which on ultrasound has the appearance of an ectopic pregnancy or a pregnancy of unknown location
    4. No clinical evidence of intra-uterine bleeding
    5. No pallor
    6. No guarding/rigidity on abdominal examination
    7. Stable blood pressure and heart rate
    8. Normal haemaglobin on full blood examination at day 1.
    E.4Principal exclusion criteria
    1. History of significant pulmonary disease (eg lung carcinoma including mesothelioma, chronic obstructive airways disease, emphysema, pneumonitis, silicosis, pulmonary fibrosis, severe/brittle asthma, ILD)
    2. Abnormal liver indices
    3. Abnormal renal indices
    4. Abnormal haematological indices
    5. Significant pre-existing dermatological condition (eg psoriasis, excema)
    5. Significant pre-existing gastrointestinal illness (eg inflammatory bowel disease, bowel carcinoma)
    6. Japanese ethnicity.
    E.5 End points
    E.5.1Primary end point(s)
    Tracking successful resolution of the ectopic pregnancy: this will be done using the existing protocols available to track resolution of ectopic pregnancies after medical management of single agent MTX. Serum hCG will be measured at day 1, 4 and 7. The medical treatment will be deemed to be working if serum hCG drops by at least 15% from day 4 to 7, and continues to drop with weekly measurements. Cure will be evidenced by the fact that hCG levels drop below 5 iu/l (lower limit of the assay). In addition, we will be in contact with the patient regularly and on a daily basis for the first week. We will ask the patients to attend for examination if they describe symptoms of possible rupture of the ectopic pregnancy (eg increasingly severe abdominal pain, dizziness).
    E.5.1.1Timepoint(s) of evaluation of this end point
    We plan to see patients on day of treatment - Day 1 - then Day 4 and 7 when they attend for scheduled appointments at the Pregnancy Support Centre. We will telephone them on days 2,3,5,6 to ask about any adverse events. We will then follow them to resolution of their ectopic when their serum hCG is below 5 iu/l. This time cannot be defined. We will then contact them at 3, 6 , 12 and 24 months to gather information about their mentrual and pregnancy history.
    E.5.2Secondary end point(s)
    Incidence of side effects: we will document side effects by way of history, examination (if indicated) and investigation (day 4 and 7 renal function tests/liver function tests/full blood count. We will especially note the incidence of side effects specific to gefitinib (rash and lung symptoms indicating possible ILD) and MTX (nausea and vomiting, abdominal pain, neutropenia, liver toxicity).

    Tolerablility: we will note whether the regimen is well tolerated by way of history and examination (if indicated).
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    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 trial will end with the last participant's telephone call up to 24 months after cure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.1Number 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: 50
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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 as participants will be cured prior to discharge.
    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 Decision2011-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-01
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