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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2012-001509-25
    Sponsor's Protocol Code Number:RHMCAN0860
    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:2012-08-10
    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 number2012-001509-25
    A.3Full title of the trial
    COAST - Cisplatin Ototoxicity attenuated by Aspirin Trial
    A randomised, Phase II, double-blind, placebo-controlled, two arm Trial to establish whether Aspirin can reduce hearing loss/ototoxicity for patients receiving Cisplatin chemotherapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to identify if Aspirin can reduce hearing loss for patients receiving Cisplatin chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    COAST - Cisplatin Ototoxicity attenuated by Aspirin Trial
    A.4.1Sponsor's protocol code numberRHMCAN0860
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN83689269
    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 Hospital Southampton NHS Foundation Trust
    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 supportCRUK (Cancer Research UK)
    B.4.2CountryUnited Kingdom
    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 organisationSouthampton Clinical Trials Unit
    B.5.2Functional name of contact pointKaren Martin, Trials Manager
    B.5.3 Address:
    B.5.3.1Street AddressMail Point 131, Southampton General Hospital
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02381203507
    B.5.5Fax number0844 7740621
    B.5.6E-mailK.S.Martin@soton.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 No
    D.2.1.1.1Trade name Aspirin
    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 nameAspirin
    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 INNAspirin
    D.3.9.1CAS number CAS 50-78-2
    D.3.9.3Other descriptive nameAcetylsalicylic acid
    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.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 Yes
    D.2.1.1.1Trade name Omeprazole 20mg gastro-resistant tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDEXCEL-PHARMA LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameOmeprazole
    D.3.4Pharmaceutical form 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 INNOmeprazole
    D.3.9.1CAS number 73590-58-6
    D.3.9.4EV Substance CodeAS2
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    To establish whether Aspirin can reduce hearing loss/ototoxicity for patients receiving Cisplatin based chemotherapy.

    E.1.1.1Medical condition in easily understood language
    Hearing loss
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10033109
    E.1.2Term Ototoxicity
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A trial to identify if Aspirin can reduce hearing loss for patients receiving Cisplatin chemotherapy.
    E.2.2Secondary objectives of the trial
    1. To identify if it is feasible to conduct a Phase III randomised control trial of Aspirin for the same patient population.
    2. To measure the degree of hearing loss in patients receiving Cisplatin using a hearing test called the Otoacoustic emissions (OAE) test.
    3. To find out if patients can tolerate short-term, large doses of Aspirin taken with Omeprazole without unpleasant side-effects and without having to reduce the dosage of their Cisplatin chemotherapy.
    4. Additional consent will be asked to collect blood and urine samples for future ethically approved trials. These samples will be stored at the Cancer Sciences Tissue Bank, Southampton General Hospital. Patients do not have to agree to give these samples if they do not wish to. They will still be able to take part in the main trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written Informed Consent
    2.Any patient deemed fit for chemotherapy with acceptable laboratory values and offered a cumulative dose equal to or more than 200mg/m2 Cisplatin as a single agent or as a combination chemotherapy for malignancy with planned treatment of a maximum of two consecutive days Cisplatin per cycle.
    3.Over 18 years old.
    E.4Principal exclusion criteria
    1.Previous Cisplatin treatment.
    2.Patients with a diagnosis of Nasopharyngeal (or skull base) Carcinoma.Patients with other head and neck tumours being treated with radiotherapy are eligible.
    3.Patients where planned Cisplatin is to be given as a split dose regimen on Days 1 to 5 or on Days 1 and 8.
    4.Patients receiving therapeutic Aspirin defined as >75mg per day.
    5.Previous Haemorrhagic stroke.
    6.Inflammatory bowel disease.
    7.Patients with absolute contraindications to Aspirin, PPIs or their excipients i.e. allergies, ulcers, renal impairment or use of oral anticoagulants.
    8.Haematological or clotting disorders.
    9.Patients with symptomatically overt hearing loss which the principal investigator considers should exclude the use of cisplatin.
    10.Pregnant or breast-feeding patients. Women of childbearing potential must have a standard negative pregnancy test performed within 7days prior to the start of Trial drug. Both men and women enrolled in this Trial must use adequate birth control.
    11.Patients enrolled or who plan to enrol in any other IMP or Surgical Interventional Clinical Trial during the Trial period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the total difference in hearing before and within 4 to 7 days after finishing treatment, using the pure tone audiogram (PTA) test at frequencies of 6 and 8 kHz in both ears.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All patients will receive a pre-treatment hearing test which will be used as a baseline measurement. Patients will have a second hearing test 4 to 7 days post treatment. They will then have a final hearing test three months after completion of their Cisplatin chemotherapy.
    E.5.2Secondary end point(s)
    1.Total difference in hearing before and 3 months after treatment using the PTA test at frequencies of 6 and 8 kHz in both ears.
    2.Common Toxicity Criteria (CTC) – a clinician assessed level of hearing loss.
    3.OAE profile, before and 4 to 7 days after treatment, and a further 3 months after finishing treatment).
    4.Safety profile assessment (including gastro-intestinal and renal toxicity).
    5.Assessment of compliance and concomitant medications as well as total dose of Cisplatin received.
    6.Assessment of other PTA test-frequencies including 0.25, 0.5, 1, 2, 3, 4 kHz at baseline and 4 to 7 days after finishing treatment. The final test to be done a further 3 months after treatment.
    7.Cisplatin dose-intensity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • All hearing assessments (PTA and OAE) will be at baseline, 4 to 7 days after finishing Cisplatin treatment and 3 months after finishing Cisplatin treatment.
    • Common Toxicity Criteria (CTC) – a clinician assessed level of hearing loss at each patient visit.
    • Safety profile assessment (including gastro-intestinal and renal toxicity) at each patient visit.
    • Assessment of compliance and concomitant medications as well as total dose of Cisplatin received at each patient visit.
    • Cisplatin dose-intensity assessed at each patient visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 concerned13
    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
    LVLS. However, at this point a decision will be made to determine whether to proceed to a Phase III trial
    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 months0
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days31
    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 state94
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 94
    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)
    Trial patients will have completed their Cisplatin chemotherapy whilst on the trial and will therefore not need any further intervention.
    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 Decision2012-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-30
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