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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2007-004486-17
    Sponsor's Protocol Code Number:A4021020
    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:2007-10-15
    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 number2007-004486-17
    A.3Full title of the trial
    A PHASE 1/PHASE 2 STUDY OF CP-751,871 IN PATIENTS WITH RELAPSED AND/OR REFRACTORY EWING’S SARCOMA FAMILY OF TUMORS
    A.4.1Sponsor's protocol code numberA4021020
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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.3.2Product code CP-751,871
    D.3.4Pharmaceutical form
    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.3.9.2Current sponsor codeCP-751,871
    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 No
    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
    Ewing's sarcoma family tumours
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10015562
    E.1.2Term Ewing's sarcoma metastatic
    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
    Primary Objective:
    To define the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of CP-751,871 in adolescents (10-18 years).
    Phase 2
    To define the efficacy of CP-751,871, in terms of objective response rate, in patients with relapsed/refractory Ewing’s sarcoma family of tumors.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    To characterize the safety and tolerability profile of CP-751,871 in adolescents;
    To evaluate the PK of CP-751,871 in adolescents;
    To test for the occurrence of Anti-Drug Antibody (ADA) response to CP-751,871 in
    adolescents.
    Phase 2
    To obtain preliminary Progression Free Survival (PFS) information in ESFT patients
    treated with CP-751,871;
    To obtain preliminary Overall Survival (OS) information in ESFT patients treated
    with CP-751,871;
    To assess CP-751,871 safety in this patient population;
    To collect PK data of CP-751,871 for future population PK meta-analysis;
    To monitor for the occurrence of ADA response to CP-751,871.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular Profiling Supplement
    version date 12 July 2007
    The primary objective of this additional research component is to collect, store, and use samples to investigate possible associations between genomic and metabonomic variation:
    • in relation to response to the study drugs, and
    • in relation to characteristics of the disease/condition under study in the associated clinical trial, and related conditions.
    E.3Principal inclusion criteria
    1. Phase 1: Male and female patients 10-18 years old. Phase 2: Male and female patients at least 10 years old. This is multiple center and multinational study. Individual investigators may elect to restrict enrollment to an older age cohort, eg, 13 years old or older, according to local institutional practices;
    2. Phase 1 Dose Escalation: Histologically or cytologically confirmed (no new biopsy
    required) diagnosis of sarcomas including osteosarcoma, rhabdomyosarcoma,
    non-rhabdomyosarcoma soft tissue sarcoma, desmoplastic small round cell tumor
    (DSRCT) or any ESFT, ie, Ewing’s sarcoma, extra-osseous Ewing’s sarcoma,
    Askin’s and Primitive Neuroectodermal Tumors (PNET);
    Phase 1 RP2D Extension: Sarcoma patients as defined in the Phase 1 Dose Escalation inclusion criterion. Upon opening of the Phase 2 portion of the study, Ewing’s sarcoma patients with at least one measurable lesion as defined by RECIST will be enrolled in the Phase 2 cohort. Ewing’s sarcoma patients with non RECIST
    measurable disease may be enrolled in the Phase 1 RP2D Extension cohort;
    4. Phase 2: Histologically confirmed (no new biopsy required) ESFT of the bone or soft tissue (Ewing’s sarcoma, extra-osseous Ewing’s sarcoma, PNET and Askin’s
    tumors);
    5. Current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life;
    6. Phase 2 only: Progressive disease with at least one measurable lesion as defined by RECIST;
    7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 or a Lansky score >/=80%;
    8. Life expectancy of at least 3 months;
    9. Adequate recovery from major surgery prior to study treatment. Wound healing must be complete;
    10. Adequate bone marrow function documented within 2 weeks prior to treatment,
    defined as:
    Absolute Neutrophil Count (ANC) >/=1000/µL;
    Platelets >/=75,000/µL (Previous transfusion is allowed);
    Hemoglobin >/=8 g/dL (Previous transfusion is allowed).
    11. Adequate renal, hepatic and cardiac functions documented within 2 weeks prior to study treatment, defined as:
    Total bilirubin </=1.5 times the Upper Limit of Normal (ULN) for age (except for
    Gilbert’s syndrome patients);
    Serum alanine aminotransferase (ALT) </=2.5 x ULN for age;
    Aspartate aminotransferase (AST) </=2.5 x ULN for age;
    Serum creatinine </=1.5 x ULN for age;
    Cardiac Shortening Fraction >/=28% or Ejection Fraction ≥50%.
    12. Phase 1: Prior radiotherapy (at least 1 week prior to enrollment). Phase 2: Prior
    radiotherapy (at least 1 week prior to enrollment) is allowed provided is not at the
    only site of measurable disease. A measurable lesion that has been irradiated will beconsidered measurable only when it has increased in size. Patients must have
    recovered from all acute radiation toxicities (< Grade 1 or deemed irreversible) before
    enrollment (Prior radiotherapy is not required for inclusion);
    13. Fully recovered (< Grade 1 or deemed irreversible) from the acute effects of prior
    cancer therapy before initiation of study treatment, including a recovery period of a
    minimum of 2 weeks since previous chemotherapy (8 weeks for mitomycin C or
    nitrosoureas) and 4 weeks from prior antibody therapy. Recovery from previous
    investigational therapy must be discussed with the Sponsor;
    14. Sexually active female patients must be either postmenopausal or, if of childbearing age, must be surgically sterile or must agree to use effective contraception during the period of therapy and up to 150 days after the last dose of CP-751,871. Acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device).
    The following forms are not acceptable:
    withdrawal method, rhythm method, spermicides, barrier sponge with or without spermicide. Within these limits, the specific form of contraception employed is left to the discretion of the subject, principal Investigator, and/or primary care physician.
    Sexually active male patients must be sterile or must agree to use effective
    contraception during the period of therapy and up to 150 days after the last dose of
    CP-751,871;
    15. All sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment;
    16. Concurrent bisphosphonate treatment is allowed if established at least one week
    before enrollment;
    17. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
    18. All adult patients must sign a written voluntary informed consent. Parent or legal
    guardian consent or patient assent/parent permission will be required for minors as
    per institutional practice.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the trial, unless there is a
    compelling reason which is to be agreed by the investigator and sponsor prior to
    randomization:
    1. Concurrent treatment with any anti tumor agents;
    2. Phase 2 only: Prior anti-IGF-IR therapy;
    Patients with symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have
    recovered from the acute effects of radiation therapy or surgery prior to the start of
    study medication, have discontinued corticosteroid treatment for these metastases for at least 1 week, and are neurologically stable;
    4. Breastfeeding females;
    5. Significant active cardiac disease including: uncontrolled high blood pressure
    (no greater than 2 SD above the mean for age for SBP and DBP), unstable angina,
    congestive heart failure, valvular disease, endocarditis, myocardial infarction within
    the previous 6 months, or serious cardiac arrhythmias;
    6. Subjects who are receiving chronic high dose immunosuppressive steroid therapy
    within 2 weeks prior to enrollment (eg, for adults: >/=100 mg prednisone per day or
    >/=40 mg dexamethasone per day; for children: >/=20 mg prednisone or ≥2 mg
    dexamethasone per day);
    7. Active infection;
    8. HbA1c>8%;
    9. History of malignancies not included in this protocol, within 5 years prior to
    enrollment, at sites other than curatively treated in situ carcinoma of the cervix, or the uterus, or basal or squamous cell carcinoma of the skin;
    10. Other severe acute or chronic medical or psychiatric condition or laboratory
    abnormality that may increase the risk associated with study participation or
    investigational product administration or may interfere with the interpretation of
    study results and, in the judgment of the Investigator, would make the subject
    inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    Primary Endpoint:
    Adverse events and laboratory abnormalities
    (CTCAE v3.0 grade, timing, seriousness and relatedness).
    Secondary Endpoints:
    PK parameters of CP-751,871;
    ADA
    Phase 2
    Primary Endpoint:
    Objective responses (RECIST).
    Secondary Endpoints:
    Progression-free survival;
    Survival;
    Adverse events and laboratory abnormalities
    (CTCAE v3.0 grade, timing, seriousness and relatedness);
    Peak and trough concentrations of CP-751,871;
    ADA.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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 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 Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the study as stated in the regulatory application
    An End of Treatment visit will take place 28 days after the last dose or sooner if the patient withdraws from the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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) 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 100
    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)
    Please refer to the study protocol sections 6.3 & 6.4
    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 Decision2007-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-24
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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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