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    Summary
    EudraCT Number:2011-000978-53
    Sponsor's Protocol Code Number:DX10008
    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:2011-04-27
    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 number2011-000978-53
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled Phase II proof-of-concept study of APD515 solution for oromucosal and oral administration for relief of xerostomia in patients with cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the effectiveness of a medicine called APD515, designed to be applied to the lining inside the mouth, at relieving dryness of the mouth
    A.3.2Name or abbreviated title of the trial where available
    Phase II PoC study of APD515 v1.1
    A.4.1Sponsor's protocol code numberDX10008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01331746
    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 SponsorAcacia Pharma Ltd
    B.1.3.4CountryUnited Kingdom
    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 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 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 nameAPD515
    D.3.2Product code APD515
    D.3.4Pharmaceutical form Oromucosal liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETHANECHOL CHLORIDE
    D.3.9.1CAS number 590636
    D.3.9.2Current sponsor codeAPD515
    D.3.9.3Other descriptive nameBETHANECHOL
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboOromucosal liquid
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Xerostomia
    E.1.1.1Medical condition in easily understood language
    Dry mouth
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10048223
    E.1.2Term Xerostomia
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the effectiveness of APD515 at relieving dry mouth in advanced cancer patients.
    E.2.2Secondary objectives of the trial
    To confirm the safety and tolerability of APD515.
    To assess patient preference for APD515.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged ≥ 18 years
    2. Able and willing to give written informed consent.
    3. Confirmed primary neoplasm at any site (apart from non-melanoma skin cancers), for which first-line cytotoxic therapy has been completed more than one month prior to study entry. Ongoing palliative, hormonal, cytostatic or “targeted” (e.g., monoclonal antibody, tyrosine kinase inhibitor, etc) therapy is permitted, provided that the risk of oral mucositis in the subject is not judged to be significant.
    4. Subjective complaint of dry mouth, ongoing for at least two weeks prior to study entry.
    5. Capacity for salivary stimulation, as demonstrated by stimulated whole saliva flow rate > unstimulated whole saliva flow rate.
    6. Karnofsky performance score ≥ 60% or ECOG performance status ≤ 2.
    7. Adequate renal and hepatic function and hydration status:
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN);
    • Serum urea < 1.5 x ULN and serum urea:creatinine ratio < 100 (where urea and creatinine expressed in the same units);
    • Plasma sodium ≤ ULN.
    8. Adequate haematological function:
    • Haemoglobin ≥ 9 g/dL;
    • White blood count ≥ 1.0 x 10^9/L;
    • Platelet count ≥ 50 x 10^9/L.
    9. Willing to use an effective form of contraception during the study and for a period of fourteen days afterwards:
    • For male subjects adequate contraception may be achieved through abstinence from sexual intercourse or use of a double barrier method of contraception.
    • For female subjects adequate contraception may be achieved through abstinence from sexual intercourse, surgical sterilization (of subject or partner), by being post-menopausal (no spontaneous menstrual period for at least one year), or by the use of a double barrier method of contraception.
    E.4Principal exclusion criteria
    1. Confirmed diagnosis of Sjögren’s syndrome.
    2. Prior radiotherapy for head & neck cancer, or other substantial doses of radiation delivered to the area of the mouth or salivary glands.
    3. Significant, symptomatic disease of the oral cavity, including oral candidosis or oral mucositis.
    4. Allergy to active ingredient or any of the excipients of APD515.
    5. Use of oral or topical (including ocular) pilocarpine or cevimeline in the two weeks prior to enrolment.
    6. Concomitant use of procainamide, quinidine or ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan.
    7. Intestinal or urinary obstruction.
    8. Myocardial infarction or intestinal anastomosis within the previous 6 months.
    9. Participation in an investigational drug or device study within 1 month prior to study entry.
    10. For female subjects only, a positive pregnancy test.
    11. Female subjects who are lactating.
    12. Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the score on a 100mm visual analogue scale (VAS) in response to the question “How dry is your mouth at present?”
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 7 of treatment period
    E.5.2Secondary end point(s)
    • Subjective measure of oral comfort, difficulty in speaking and difficulty in swallowing, as recorded on a 100mm visual analogue scale.
    • Improvement or otherwise in subjective sensation of oral dryness, oral comfort and difficulty in speaking and swallowing, on direct questioning;
    • Subjective assessment of overall value of treatment and theoretical willingness to continue;
    • Subjective differentiation of active and placebo;
    • Unstimulated whole saliva flow rate;
    • Usage of non-pharmaceutical preparations for xerostomia relief;
    • Nature and frequency of oromucosal lesions and other adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 7 of treatment period
    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 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) 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 Yes
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA7
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Because the study is double-blind, there will be no way of knowing if APD515 was of any benefit to the subject until all the data are analysed, after the whole study has ended. Therefore it would not be appropriate to provide continuing treatment with APD515 to an individual subject after completion of their treatment periods.
    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 Decision2011-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-20
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