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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2011-005554-62
    Sponsor's Protocol Code Number:ASSG03
    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:2012-03-21
    Trial 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 number2011-005554-62
    A.3Full title of the trial
    Pharmacokinetics and Pharmacodynamics of Doxorubicin in Children, Adolescents and young adults with Newly Diagnosed Osteosarcoma, Ewing Family of Tumours and Hodgkin Lymphoma
    A Multi-Institutional Cross-Discipline Non-Therapeutic Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the pharmcokintetics (how the body processes with a drug) and pharmcodynamics (what effect the drug has on the body) of the chemotherapy drug doxorubicin, when used to treat children, adolescents and young adults with newly diagnosed cancers: osteosarcoma, Ewing's family of tumours, and Hodgkin lymphoma.
    A.3.2Name or abbreviated title of the trial where available
    AYAPK- Adolescents and Young Adults PK
    A.4.1Sponsor's protocol code numberASSG03
    A.5.4Other Identifiers
    Name:Australian New Zealand Clinical Trial RegistryNumber:ACTRN12609000956202
    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 SponsorAustralian Sarcoma Group (ASSG)
    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 supportASSG (Australian Sarcoma Study Group)
    B.4.2CountryAustralia
    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 Doxorubicin
    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 namedoxorubicin
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.4EV Substance CodeAS1
    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 Doxorubicin
    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 nameDoxorubicin
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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
    Ewing family of tumours
    Osteosarcoma
    Hodgkin lymphoma
    E.1.1.1Medical condition in easily understood language
    Ewing family of tumours is a cancer that affects bones and soft tissues, osteosarcoma is a primary bone cancer, and Hodkin lyphoma is a cancer of the lymph glands.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10015570
    E.1.2Term Ewing's tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10031291
    E.1.2Term Osteosarcoma
    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 evaluate the effect of gender on the pharmacokinetics (PK) of doxorubicin in AYA* patients with newly diagnosed:
    -Ewing family of tumours (EFT)**
    -Osteosarcoma (OS); or
    -Hodgkin lymphoma (HL)
    *AYA is defined as young people who have entered puberty (Tanner stage ≥2) or are pubertally mature, regardless of whether they are being treated on an adult chemotherapy regimen or a children’s chemotherapy regimen.
    **EFT includes Ewing’s sarcoma of bone, extra-osseous Ewing Sarcoma, and PNET (primitive neuroectodermal tumour) outside the central nervous system.
    E.2.2Secondary objectives of the trial
    1) To evaluate the effect of gender and pubertal stage on the pharmacokinetics(PK) of doxorubicin in children and AYA with newly diagnosed:
    - Ewing family of tumours (EFT); or
    - Osteosarcoma (OS)

    2)To explore the relationship between doxorubicin PK and doxorubicin pharmacodynamics (PD), in children and AYA with newly diagnosed EFT, OS or HL, where PD is measured by each of the following metrics in turn:

    a)Worst grade of neutropenia( Low white blood Cells), thrombocytopenia (Low Platelets), or mucositis (Sore Mouth) in cycle 1 of chemotherapy, as measured at the scheduled assessment times .

    b) Tumour response, which will be measured in different ways for different groups of patients as follows
    - by International Working Group Criteria 33 for HL patients;

    - by tumour necrosis( Amount of dead tumour following chemotherapy) for OS and EFT patients where surgery is performed; and

    - by RECIST criteria (RECIST creiteria is an objective scheme for measuring tumour resp
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Newly diagnosed with osteosarcoma, Ewing family of tumours or Hodgkin lymphoma
    - ≥1 year and 40years of age (in the UK only patients aged 11 - 40 years will be recruited)
    - Planned treatment involves standard of care doxorubicin-containing regimens.
    - Written informed consent from patient and/or patient’s parent or legal guardian.
    E.4Principal exclusion criteria

    - Impaired hepatic function such as known chronic liver disease, evidence of impaired synthetic function or transaminases raised >5 x normal

    - Significant uncontrolled systemic illness as judged by investigator

    - Females who are pregnant or breast feeding
    E.5 End points
    E.5.1Primary end point(s)

    The primary endpoint will be AUC (Area Under the Curve) calculated from the doxorubicin concentration-time curves (Ct) derived from the PK samples.

    N.B The primary aim of the study is to evaluate the effect of gender on pharmacokinetcs of doxorubicin in children and young adults with newly diagnosed Ewing family of tumours, osteosarcoma and Hodgkin lymphoma.



    E.5.1.1Timepoint(s) of evaluation of this end point
    The PK will be evaluated during the first cycle of chemotherapy.
    E.5.2Secondary end point(s)
    To evaluate the effect of gender and pubertal stage on the pharmacokinetics (PK) of doxorubicin in children and adolescents and young adults (AYA) with newly diagnosed Ewing family of tumours (EFT) or osteosarcoma (OS).
    To explore the relationship between doxorubicin PK and pharmacodynamics (PD)in children and AYA wtih newly diagnosed EFT, OS and Hodgkin lymphoma, where PD is measured by:
    - worst grade of neutropenia, thrombocytopenia, or mucositis in cycle 1 of chemotherapy
    - tumour response (on imaging, and resection specimen of EFT and OS patients undergoing surgery).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The worst grade of neutropenia, thrombocytopenia, or mucositis will be evaluated at the end of cycle 1 of chemotherapy.
    Tumour response will be evaluated by imaging at the first imaging time point as specified by the standard treatment schedule for the different tumours; and by surgery which is carried out after the initial block of chemotherapy for EFT and OS as specified buy the standard treatment schedule.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    This is an observational PK study of an established agent, doxorubicin.
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    New Zealand
    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 end of the study is defined as after the last patient has had surgery, or in the absence of surgery, after imaging (CT or MRI scan) has been been performed to assess response to chemotherapy. This will be after the last clinic visit of patients.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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 months3
    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: 80
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-21. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 210
    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)
    Standard Care
    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 Decision2012-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-06
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