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    Summary
    EudraCT Number:2016-001046-26
    Sponsor's Protocol Code Number:NO21200
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-09-30
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2016-001046-26
    A.3Full title of the trial
    Multiple Ascending Dose (MAD) Phase I Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Children and Adolescents with Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors
    A.4.1Sponsor's protocol code numberNO21200
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00560144
    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 SponsorF. Hoffmann-La Roche AG
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche AG
    B.5.2Functional name of contact pointRoche Trial Information Hotline
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH 4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41616878333
    B.5.6E-mailglobal.trial_information@roche.com
    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 R1507
    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.3.8INN - Proposed INNhuMAb IGF-1R
    D.3.9.2Current sponsor codeR1507
    D.3.9.3Other descriptive nameHUMANISED MONOCLONAL ANTIBODY AGAINST INSULIN-LIKE GROWTH FACTOR RECEPTOR TYPE I (IGG-1R)
    D.3.9.4EV Substance CodeSUB23109
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent or refractory malignant solid tumors in children between 2 and 17 year of age
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine the dose of R1507, a monoclonal antibody to the Type I Insulin-like Growth Factor Receptor (IGF-IR), that achieve serum drug exposure levels (AUC) in children and adolescents with advanced solid tumors that are equivalent to the exposures in adults at the adult recommended doses of 9mg/kg administered on a weekly schedule and 16 mg/kg administered every 3 weeks.
    - To determine the maximum tolerated dose (MTD) of R1507 in children and adolescents with advanced solid tumors IF dose-limiting toxicity is observed in 2 or more patients at any dose level on the weekly or every 3 week schedules.
    E.2.2Secondary objectives of the trial
    - Describe the tolerability and adverse event profile of R1507 administered weekly or every 3 weeks in children and adolescents with advanced solid tumors.
    - Describe the pharmacokinetic profile of R1507 after single and repeated dosing in children and adolescents with advanced solid tumors.
    - Describe any anti-tumor responses to R1507.
    - Describe the early effects of R1507 on tumors by PET scan.
    - Investigate the expression of IGF-related signaling pathways in archival tumor tissue using immunohistochemistry.
    - Assess the development of an immunologic response (HAHA) to R1507.
    - Assess changes in IGF-1R related signaling molecules in patient serum samples.
    - Determine the appropriate dose of R1507 for further disease-directed/ phase II studies in children and adolescents with advanced solid tumors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pediatric patients aged 2-17 years of age;
    - Histologically confirmed solid tumors;
    - Cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.
    E.4Principal exclusion criteria
    - Treatment with corticosteroids within past 2 weeks;
    - Current or past use of anti-IGF-1R antibodies;
    - Current treatment with immunosuppressive agents;
    - Patients with diabetes mellitus;
    - Known HIV or hepatitis B or C;
    - Hypersensitivity to any of the components of R1507 or to monoclonal antibodies.
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum drug exposure level equivalent to exposure in adults at adult recommended doses
    2. Maximum tolerated dose (adverse events, laboratory parameters)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Weeks 1, 2, 3, 4, 5, and 6, then every 3 weeks thereafter (Weeks 9, 12, etc.) and at final visit.
    E.5.2Secondary end point(s)
    1. Tumor response rate according to RECIST criteria
    2. Percentage of participants with adverse events and serious adverse events
    3. Percentage of participants with laboratory abnormalities
    4. Percentage of participants with formation of human anti-human antibodies (HAHAs)
    5. Immune reconstitution (Quantitative evaluation of lymphocyte subsets in the peripheral blood)
    6. Maximum plasma concentration (Cmax)
    7. Time to reach the maximum concentration (Tmax)
    8. Minimum concentration per dosing interval (Cmin)
    9. Area under the concentration-time cure (AUC)
    10. Clearance (CL)
    11. Volume of distribution at steady state (VDss)
    12. Terminal elimination half-life (T1/2)
    13. Maximum Standardized Uptake Value (SUV) in tumor pretreatment versus one day after the second dose.
    14. Average SUV in tumor pretreatment versus one day after the second dose
    15. Expression of IGF-related signaling pathways in archival tumor tissue
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measurements completed at Screening, Week 1, Week 2, Week 3, Subsequent Weeks, Final Visit (7 days post-dose) and Follow-up Visit (30 days post-dose)

    PK Sampling Schedule:

    qW Dosing: Week 1 (Days 1, 2, 3 and 4 pre-dose, end of infusion and 6, 24, 48 and 72 hours after dosing), Week 2, 4 and 6 (Day 1 pre-dose and end of infusion), Week 8 and 10 (Day 1 pre-dose), and Weeks 1 and 4 off-study (Days 7 and 30).

    q3W Dosing: Cycle 1 Day 1 (pre-dose, end of infusion and 6, 24, 48 and 72 hours after dosing); Cycle 1 Days 8 and 15; Cycle 2 Day 1 (pre-dose and end of infusion); Cycle 3 Day 1 (pre-dose and end of infusion); Cycle 3 Day 8 Cycle 4 Day 1 (pre-dose and end of infusion); Final and Follow-up Visit (7 and 30 days after last dose)
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose-finding in children and adolescents
    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 Yes
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    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: 58
    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: 18
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    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
    As the subjects included in this trial are under the age of 18, their legal representatives must provide consent on their behalf as required.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 58
    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)
    Subjects that were still receiving therapeutic benefit at the conclusion of the study were allowed to continue to receive R1507 via an investigator sponsored single IND trial (IND 11-008351) until drug expiry.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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