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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2007-005341-38
    Sponsor's Protocol Code Number:P04720
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005341-38
    A.3Full title of the trial
    A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing’s Sarcoma That Has Relapsed After Standard Systemic Therapy.
    A.3.2Name or abbreviated title of the trial where available
    P04720
    A.4.1Sponsor's protocol code numberP04720
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSchering Plough Research Institute
    B.1.3.4CountryUnited States
    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 nameanti-IGF-1R monoclonal antibody
    D.3.2Product code SCH 717454
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 934235-44-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeMonoclonal Antibody
    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
    Relapsed resectable and unresectable Osteosarcoma, Ewing Sarcoma.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives:
    Group 1
    -To determine tumor cell proliferation response after dosing with SCH 717454 in Subjects with resectable osteosarcoma that has relapsed after standard systemic therapy compared to the subject’s historical tumor cell proliferation.

    Group 2
    -To determine the World Health Organization (WHO) and Response Evaluation Criteria in Solid Tumors (RECIST)-defined radiological response rate to SCH 717454 in subjects with unresectable osteosarcoma refractory to standard therapy.

    Group 3
    -To determine the WHO and RECIST-defined radiological response rate to SCH 717454 in subjects with Ewing’s sarcoma refractory to standard therapy.
    E.2.2Secondary objectives of the trial
    Group 1
    -To determine time to progression after dosing with SCH 717454 in subjects with resectable osteosarcoma that has relapsed after standard systemic therapy.

    All Groups
    -To evaluate the safety and tolerability of SCH 717454 administered every 2 weeks in subjects with osteosarcoma and Ewing’s sarcoma relapsed after standard systemic therapy.
    -To evaluate peripheral blood levels of
    -Insulin-like Growth Factor I (IGF-I), and IGF-II,
    -Insulin-like Growth Factor binding protein 2 (IGFBP-2), and Insulin-like Growth Factor binding protein 3 (IGFBP-3), as well as
    -Insulin-like Growth Factor 1 Receptor (IGF-1R) expression on peripheral blood mononuclear cells (PBMC) by fluorescence activated cell sorting (FACS),
    -To determine the incidence of anti-SCH 717454 antibodies.
    -To evaluate serum SCH 717454 concentrations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A subject must be older than 11 years of age and may be of any race, and gender;

    2. A subject must have a diagnosis of histologically confirmed osteosarcoma or Ewing’s sarcoma;

    3. A subject with either:
    a. relapsed and resectable osteosarcoma (to be included in Group 1) that:
    - has recurred after prior systemic treatment with active chemotherapy agents (ie, prior exposure to a cisplatinum/doxorubicin and an ifosfamide containing regimen; and
    - must have had the confirmed relapse within 6 months of the immediate prior treatment of the osteosarcoma (longer intervals require discussion with the sponsor); and
    - must have a surgical or core biopsy tumor specimen (available to determine historical tumor proliferation), and the subject must not have been receiving tumor directed therapy at the time the specimen was obtained, or must have been progressing while on that treatment. The specimen should have been obtained within 8 months of study entry (specimens >8 months before study entry require discussion with the sponsor).
    b. relapsed and unresectable osteosarcoma (to be included in Group 2) that is refractory to standard therapy, ie has relapsed after prior systemic treatment with active chemotherapy agents (ie, prior exposure to a cisplatinum/doxorubicin and an ifosfamide containing regimen). The subject must have measurable disease on a CT or MRI study performed during Screening (within 21 days of Day 1);
    c. Ewing’s sarcoma (to be included in Group 3) that is refractory to standard systemic therapy (ie, ifosfamide/etoposide; and cyclophosphamide, doxorubicin, and vincristine). The subject must have measurable disease on a CT or MRI study performed during Screening (within 21 days of Day 1).

    4. A subject >16 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; a subject ≤ 16 years of age must have a Karnofsky performance status between 50% and 100% or a Lansky play scale between 50% and 100%;

    5. A subject must have a minimum life expectancy of ≥4 months;

    6. A subject must have adequate organ function within 3 weeks prior to Day 1 as
    evidenced by:
    a. hemoglobin ≥9 g/dL (≥8 g/dL in subjects with Ewing’s sarcoma),
    b. absolute neutrophil count ≥1.5 x 109/L (≥1.0 x 109/L in subjects with Ewing’s sarcoma),
    c. platelet count ≥100 x 109/L (≥50 x 109/L in subjects with Ewing’s sarcoma),
    d. creatinine <1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL/min,
    e. total bilirubin <1.5 x ULN, except for subjects with Gilbert’s disease,
    f. aspartate aminotransferase (AST)/serum glutamic-oxalacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <3 x ULN, or in the presence of documented liver metastases ≤5 x ULN. Out-of-range laboratory values at Screening may be repeated once during the Screening Period.

    7. A subject (and/or parent/guardian for subjects under the age of legal consent)
    must give written informed consent and be able to adhere to dose and visit schedules;

    8. A female subject and a male subject’s female partner, of childbearing potential, must agree to use a medically accepted method of contraception prior to Screening, while receiving protocol-specified medication, and for 2 months after stopping the medication. Acceptable methods of contraception include abstinence; condoms (male or female) with or without a spermicidal agent; diaphragm or cervical cap with spermicide; medically prescribed intrauterine device; oral, transdermal, or injectable hormonal contraceptive; and surgical sterilization (eg, hysterectomy or tubal ligation).

    A woman of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
    E.4Principal exclusion criteria
    The subject will be excluded from entry if ANY of the criteria listed below are met:
    1. A subject with a history of another malignancy (with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix treated with curative
    intent at least 2 years prior to start of treatment, or other adequately treated
    malignancy for which the subject has been disease free for ≥5 years);

    2. A subject who has known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion;

    3. A subject with a history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of ≥7.5% in a patient with known diabetes mellitus;

    4 A subject with a recent myocardial infarction (within the past year); or a subject who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality;

    5. A subject with an active infection;

    6. A subject with clinically significant hepatitis at Screening, or a subject that is
    hepatitis C antibody positive, hepatitis B surface antigen positive, or human
    immunodeficiency virus (HIV) seropositive;

    7. A subject who has been treated with an anti-IGF-1R targeted drug or antibody;

    8. A subject with known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications;

    9. A subject with persistent, unresolved common terminology criteria for adverse
    events (CTCAE) ≥ Grade 2 drug-related toxicity associated with previous treatment (inclusion of subjects with persistent neuropathy or hearing loss ≥Grade 2 due to previous treatment require discussion with the sponsor);

    10. A subject who has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study;

    11. A subject who has received any treatment listed below more recently than the indicated washout period prior to Screening or must continue to receive treatment that is listed below;
    -Concurrent chemotherapy for the purpose of treating the tumor. wash out 21 days prior to Day 1.
    -Other monoclonal antibodies. wash out Four half lives of the monoclonal antibody
    prior to Day 1.
    -Immunosuppressive medication (eg, high-dose steroids). wash out Prior to Screening.
    -Investigational drugs wash out 21 days prior to Day 1.

    12. A female subject who is breast-feeding, pregnant, intends to become pregnant, or has a positive pregnancy test at Screening;

    13. A subject participating in any other clinical study with a potentially therapeutic
    agent or who has received another investigational product within 21 days prior
    to Day 1;

    14. A subject unlikely to complete the study and appropriate follow-up visits.
    E.5 End points
    E.5.1Primary end point(s)
    Group 1
    To determine tumor cell proliferation response after dosing with SCH 717454 in subjects with resectable osteosarcoma that has relapsed after standard systemic
    therapy compared to the subject’s historical tumor cell proliferation.

    Group 2
    To determine the World Health Organization (WHO) and Response Evaluation Criteria in Solid Tumors (RECIST)-defined radiological response rate to SCH 717454 in subjects with unresectable osteosarcoma refractory to standard therapy.

    Group 3
    To determine the WHO and RECIST-defined radiological response rate to SCH 717454 in subjects with Ewing’s sarcoma refractory to standard therapy.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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 Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Active controlled
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 90
    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 Decision2008-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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