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    Summary
    EudraCT Number:2010-018373-38
    Sponsor's Protocol Code Number:RG_09-071
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2010-07-09
    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 number2010-018373-38
    A.3Full title of the trial
    A Phase I trial of figitumumab, an IGF-1R antibody, in children aged 1-12 years old with relapsed/refractory Solid Tumours
    A.3.2Name or abbreviated title of the trial where available
    FOREST
    A.4.1Sponsor's protocol code numberRG_09-071
    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 SponsorUniversity of Birmingham
    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 nameFigitumumab
    D.3.2Product code CP-751,871
    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.3.8INN - Proposed INNFigitumumab
    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
    Paediatric patients aged 1-12 years with relapsed / refractory solid tumours.
    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
    To define the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the anti-IGF-1R antibody, figitumumab, in children (1-12 years old) with advanced solid tumours.
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacokinetics (PK) of figitumumab in children.
    • To monitor for any anti-drug antibody (ADA) response to figitumumab treatment.
    • To evaluate the effect of figitumumab therapy on IGF-1 pathway serum biomarkers (i.e. total and free IGF-1, IGF-2, IGF-BP3, insulin and growth hormone).
    • To provide preliminary indications of anti-tumour efficacy in a RP2D extension cohort and preliminary descriptive data on potential biomarkers (host and tumour) associated with drug handling and anti-tumour efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 1 years and ≤ 12 years at the time of study entry.
    2. Histological confirmation of solid extra-cranial malignancy at original diagnosis.
    3. For expansion cohort only, patients must have measurable or clinically evaluable disease. Patients with neuroblastoma and other tumour types with disease assessable only by MIBG, Tc bone scan or BM aspirates/trephines are eligible.
    4. Current disease status must be one for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life.
    5. Performance Status:
    • Lansky ≥ 50%;
    • Patients who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.
    6. Adequate recovery from major surgery prior to study treatment.
    7. No mitral valve regurgitation greater than trivial as determined by Doppler echocardiogram. Shortening of fraction ≥29%.(≥35% for children <3 years). ECG without clinically significant abnormalities.
    8. Must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy. Three weeks from previous chemotherapy (two weeks for vincristine and oral metronomic chemotherapy), four weeks from previous radiotherapy and six weeks from previous nitrosureas or myeloablative chemotherapy.
    9. Adequate bone marrow function defined as:
    • Platelet count ≥75,000/µL (unsupported during prior 72 hours, except patients with BM disease on expansion cohort)
    • Haemoglobin ≥8.0 gm/dL (unsupported during prior 72 hours, except patients with BM disease on expansion cohort)
    • Peripheral absolute neutrophil count (ANC) ≥1000/µL (without growth factor support during prior 72 hours)
    • Patients with pancytopenia due to bone marrow metastasis will be eligible for study only for the Recommended Phase 2 expansion cohort and will not be evaluable for haematologic toxicity. These patients must not be refractory to red blood cell or platelet transfusions, and should be transfused to adequate levels as defined above prior to each cycle. In these patients, ANC must be above ≥500/µL without growth factor support during the prior 72 hours
    10. Adequate renal function, defined as:
    Serum creatinine 1.5 x upper limit normal (ULN) for age. If above, creatinine clearance must be calculated with an accurate methodology (such as radioisotope GFR or inulin). If creatinine clearance is measured, GFR should be ≥60 ml/min/1.73m2.
    11. Adequate liver function defined as:
    • Total bilirubin (conjugated + unconjugated) ≤ 1.5x the upper limit of normal (ULN) for age (except patients with liver metastasis or Gilbert’s syndrome ≤ 2.5x ULN).
    • Serum alanine aminotransferase (ALT) <2.5 × ULN (<5 x ULN for patients with liver metastasis)
    • Serum aspartate aminotransferase (AST) <2.5 × ULN (<5 x ULN for patients with liver metastasis)
    12. Males or females of reproductive potential may not participate unless they agree to use an effective contraceptive method, as described in the life style guidelines section, for the duration of study therapy and for 150 days after the last dose of Figitumumab. A negative pregnancy test must be obtained within 7 days prior to dosing in girls who are post-menarche (this aspect is unlikely to be relevant for most patients aged < 13 yrs).
    13. All patients and/or their parents or legal guardians must sign a written informed consent. Assent, of the child, when appropriate, will be obtained according to institutional guidelines.
    14. Patients and/or their parents and/or legal guardians must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Concurrent treatment with any anti-tumour agents.
    2. Prior anti-IGF-1R therapy.
    3. Patients with symptomatic brain metastases
    4. Significant active cardiac disease including: cardiac shortening fraction < 29%; uncontrolled hypertension (Systolic BP and diastolic BP > 2 standard deviations (SD) above the mean for age); or serious cardiac arrhythmia(s).
    5. Active infection.
    6. Insulin-dependent diabetes mellitus as defined by glycosylated haemoglobin (Hgb A1c) ≥ 6.5%) or use of high-dose steroids (>1mg/kg/day of prednisone or >5mg/m2/day of dexamethasone).
    7. History of allergic reaction to IgG.
    8. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Safety, measured by assessment of adverse events and laboratory abnormalities (CTCAE Version 4.0: grade, timing, seriousness and relatedness)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 Information not present in EudraCT
    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
    The end of trial is defined as 6 months after last data capture. This will allow sufficient time for the completion of protocol procedures, data collection and data input.
    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 months6
    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 months6
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The trial mandate that girls of child bearing potiential use effective contraception. Consent will be obtain by the patients parent / guardian. Age appropriate information sheets will be provided for participants
    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 24
    F.4.2.2In the whole clinical trial 48
    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)
    Expected normal treatment for that condition
    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 Decision2010-07-01
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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