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    Summary
    EudraCT Number:2006-003203-40
    Sponsor's Protocol Code Number:06/085
    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:2006-09-20
    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 number2006-003203-40
    A.3Full title of the trial
    A RANDOMISED, CROSS-OVER, PHASE II STUDY, TO INVESTIGATE THE EFFICACY AND SAFETY OF GLUCARPIDASE FOR ROUTINE USE AFTER HIGH DOSE METHOTREXATE IN PATIENTS WITH BONE SARCOMA
    A.3.2Name or abbreviated title of the trial where available
    GLU-1: GLUCARPIDASE RESCUE AFTER HIGH-DOSE METHOTREXATE
    A.4.1Sponsor's protocol code number06/085
    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 SponsorUCL University 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 organisationUniversity College London Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointDr Jeremy Whelan
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Oncology, University College Hospital, 250 Euston Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW1 2PG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440203447 9346
    B.5.5Fax number440203447 9055
    B.5.6E-mailjeremy.whelan@uclh.nhs.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.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/128
    D.3 Description of the IMP
    D.3.1Product nameGlucarpidase (VoraxazeTM)
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucarpidase
    D.3.9.1CAS number 9074-87-7
    D.3.9.3Other descriptive nameCarboxypeptidase G2
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000 units/vial
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeEnzyme
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bone Sarcoma
    E.1.1.1Medical condition in easily understood language
    Bone cancer
    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 10006007
    E.1.2Term Bone sarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether glucarpidase rescue after high-dose methotrexate reduces delay to subsequent cycle of chemotherapy due to methotrexate toxicity
    E.2.2Secondary objectives of the trial
    1.To investigate whether glucarpidase rescue after high-dose methotrexate reduces the incidence, severity and duration of methotrexate associated adverse effects
    2.To study the pharmacokinetics of methotrexate and 4-deoxy-4-amino-N10-methylpteroic acid (DAMPA) after glucarpidase administration
    3.To evaluate any adverse effects associated with the use of glucarpidase
    4.To investigate the economic impact of using glucarpidase versus standard rescue
    5.To investigate the effect of glucarpidase on the quality of life of patients treated with high dose methotrexate
    6.To assess the anti-glucarpidase antibody response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent of patient or parent/guardian

    Diagnosis of high grade osteosarcoma, localised or metastatic
    or high grade osteosarcoma as a second maligancy
    or spindle cell sarcoma of bone
    or relapsed high grade osteosarcoma

    Age: 5-50 years at registration

    Patients able to comply with study and follow up procedures (WHO performance scale 0-2)

    No concomitant anti-cancer or investigational drugs during the study and complete resolution of toxicity related to previous treatment

    Life expectancy of at least 3 months

    Haematopoietic function: Absolute neutrophil count ≥1 x109/L, Platelets ≥75 x109/L

    Hepatic function: Bilirubin ≤1.5 x ULN,

    Renal function: Glomerular Filtration Rate (radioisotope) ≥ 70 ml/min/1.73m2
    E.4Principal exclusion criteria
    Patients who previously received glucarpidase

    Pregnant or breast feeding women (patients with reproductive potential of either gender must use contraception, as described in section 5.2 of the protocol)

    Concomitant treatment with agents which interact with methotrexate metabolism or excretion

    Serous effusions including ascites and pleural effusions
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of fitness to receive chemotherapy on day 15 of each cycle (fitness criteria described in section 8 of the protocol)
    E.5.1.1Timepoint(s) of evaluation of this end point
    day-7-0, day 1, day 2, day 8, Day 9, Day 15, day 22, day 23, day 29, day 30, day 36,
    E.5.2Secondary end point(s)
    1. Incidence of methotrexate-associated toxicity (CTCAE v3.0 grade ≥2)
    2. Serum methotrexate and DAMPA concentrations
    3. Anti-glucarpidase IgG antibody response and neutralisation of glucarpidase activity
    4. Number of days required in hospital per cycle and total dose of folinic acid required per cycle
    5.Quality of life assessment (QLQ-C30 version 3, FACT-G and PedsQL 3.0 cancer module acute version)
    E.5.2.1Timepoint(s) of evaluation of this end point
    day-7-0, day 1, day 2, day 8, Day 9, Day 15, day 22, day 23, day 29, day 30, day 36, Day 51, day 111, day 201
    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 Yes
    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 Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Information not present in EudraCT
    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
    standard treatment
    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 concerned2
    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
    The duration of treatment for each patient is 6 weeks (allowing for recovery after the last methotrexate course). However, patients will be followed up on day 30 and at 3 and 6 months after starting their second chemotherapy cycle to investigate anti-glucarpidase response. The trial will be completed after all 38 participants are recruited, treated and followed up.
    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 Yes
    F.1.1Number of subjects for this age range: 32
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 16
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state38
    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)
    After the end of the trial patients' treatment will follow standard practice
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-05-13
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