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    Summary
    EudraCT Number:2012-000091-41
    Sponsor's Protocol Code Number:UCL/11/0404
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-07-10
    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 number2012-000091-41
    A.3Full title of the trial
    A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine(HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine (HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG)
    A.3.2Name or abbreviated title of the trial where available
    Hydroxychloroquine Trial (HCQ)
    A.4.1Sponsor's protocol code numberUCL/11/0404
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01602588
    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 College London
    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
    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 namehydroxychloroquine
    D.3.2Product code HCQ
    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 INNhydroxychloroquine
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    High Grade glioma
    E.1.1.1Medical condition in easily understood language
    brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    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 examine the effect on one year survival of giving hydroxychloroquine (HCQ) with short course radiotherapy (SCRT) to high grade gliomas (HGG) patients aged ≥ 70 years

    Primary endpoint
    •One-year survival will be calculated from the proportion of patients surviving the first year
    E.2.2Secondary objectives of the trial
    To assess the toxicity of patients giving SCRT alone and those giving HCQ with SCRT, separately

    Secondary endpoints
    •Toxicity in both arms using RTOG neurotoxicity scores and CTCAE v4.03
    •Cause-specific survival as defined as the time from randomisation to death from HGG
    •Radiological progression free survival at 6 months as defined from the day of randomisation to the day of local tumour progression or recurrence based on the RANO response criteria for MRI, or the day of death of any cause
    •Clinical progression free survival at 6 months as defined from the day of randomisation to the day of local tumour progression or recurrence based on clinical evaluation, or the day of death of any cause.
    •QOL as determined by the EORTC QLQ-C30(BN20)questionnaire
    •Steroid dependence
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female patients aged ≥70 yrs identified through the neuro-oncology MDT
    •A histological diagnosis of HGG, either from biopsy or resection.
    •A life expectancy of > 2 months
    •An ECOG performance status of 0/1
    •Absolute neutrophil count ≥ 1.5 x 10^9 L
    •Platelet count ≥ 100 x 10^9 L
    •Bilirubin ≤ 1.5 mg/dL (or ≤ 25.6 micromol/L)
    •Creatinine ≤ 2 times upper limit of normal (ULN)
    •ALT and AST ≤ 4 times ULN
    •Mini Mental Status Exam score ≥ 17
    •Written informed consent
    •Ready to start radiotherapy within 4 weeks of surgery
    E.4Principal exclusion criteria
    •Concurrent psoriasis unless the disease is well controlled and patient is under the care of a specialist for the disorder who agrees to monitor for exacerbations
    •Prior macular degeneration or diabetic retinopathy
    •Concurrent serious infection or medical illness that would preclude study therapy
    •Another malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
    •Porphyria
    •Glucose- 6 phosphate dehydrogenase (G6PD) deficiency
    •Alcoholic liver disease
    •Any other concurrent severe/uncontrolled medical conditions
    •Currently taking amiodarone
    •Prior radiotherapy, chemotherapy, immunotherapy, biologic agents (e.g. immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumour-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy), or hormonal therapy for brain tumour
    •Prior polifeprosan 20 with carmustine implant (Gliadel wafer) or GliaSite® brachytherapy
    •Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g. phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
    •Other concurrent chemotherapeutic or investigational agents for this cancer (Concurrent glucocorticoids will be allowed)
    •Documented side effects to chloroquine or related agents.
    •Unable to give informed consent
    •Patients with a history of a psychological illness or condition that in the opinion of the investigator may adversely affect compliance with study medication
    E.5 End points
    E.5.1Primary end point(s)
    One-year survival as defined as the proportion of patients surviving the first year from randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One-year survival will be assessed as the proportion of patients surviving one year from randomisation. The Kaplan-Meier survival estimate at one year will also be used, which will be particularly useful if any patients are lost to follow-up within the first year.

    Survival will be assessed at one year after randomisation.
    E.5.2Secondary end point(s)
    To assess the toxicity of giving HCQ with SCRT

    Secondary endpoints
    •Toxicity in both arms using RTOG neurotoxicity scores and CTCAE v4.03
    •Cause-specific survival as defined as the time from randomisation to death from HGG
    •Radiological progression free survival at 6 months as defined from the day of randomisation to the day of local tumour progression or recurrence based on the RANO response criteria for MRI, or the day of death of any cause
    •Clinical progression free survival at 6 months as defined from the day of randomisation to the day of local tumour progression or recurrence based on clinical evaluation, or the day of death of any cause.
    •QOL as determined by the EORTC QLQ-C30(BN20)questionnaire
    •Steroid dependence
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Toxicity will be evaluated at specific timepoints during the trial-
    •Cause specific survival will be evaluated after the date of death for each patient
    •Radiological progression free survival will be evaluated at 6 months after date of registration for each patient
    •Clinical progression free survival will be evaluated at 6 months after date of registration for each patient.
    •QOL will be evaluated specific timepoints during the trial.
    •Steroid dependence will be evaluated at specific timepoints during the trial.
    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 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 Yes
    E.8.2.3.1Comparator description
    Short Course Radiotherapy
    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 concerned5
    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 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
    For regulatory purposes the end of the trial will be either the date of death for the last surviving patient, or 1 year after all patients have finished treatment, whichever is earlier; at which point the ‘declaration of end of trial’ form will be submitted to participating regulatory authorities and ethical committees, as required.
    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 months0
    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 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.1.1Number 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) No
    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: 57
    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 state57
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 57
    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)
    Patients will receive the local standard of care for their disease after the trial ends.
    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 Decision2012-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-25
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