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    Summary
    EudraCT Number:2007-005939-28
    Sponsor's Protocol Code Number:BO21495
    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:2008-10-21
    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 number2007-005939-28
    A.3Full title of the trial
    Open-label, multicenter, dose-escalation Phase I/II study to evaluate safety, pharmacokinetics and activity of RO5083945, a Glycoengineered Antibody against EGFR, in patients with metastatic and/or locally advanced malignant EGFR+ Solid Tumors
    A.4.1Sponsor's protocol code numberBO21495
    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 SponsorF. Hoffmann-La Roche Ltd
    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 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 namehuMAb<EGFR>
    D.3.2Product code RO5083945/F02
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNn/a
    D.3.9.1CAS number 959963-46-3
    D.3.9.2Current sponsor codeRO5083945
    D.3.9.3Other descriptive namehuMAb<EGFR> (GA201)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200mg/20ml
    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 typehumanized glycoengineered IgG1 monoclonal antibody (mAb)
    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
    Part I: Metastatic and/or locally advanced malignant solid tumors expressing Epidermal Growth Factor Receptor (EGFR)

    Part II: Metastatic or locally advanced colorectal cancer expressing EGFR and mutant Kirsten rat sarcoma 2 viral oncogene homolog (KRAS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049516
    E.1.2Term Malignant tumor
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part I of the study:
    - to describe the pharmacokinetics (PK) and maximum tolerated dose (MTD), if achieved, of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors

    Part II of the study:
    - to investigate the Tumor Growth Control Rate (TGCR): CR, PR and stable disease (SD) > 2 months and safety profile of RO5083945 in patients with metastatic and/or locally advanced colorectal cancer expressing EGFR and mutant KRAS
    E.2.2Secondary objectives of the trial
    Part I:
    - describe the tolerability and adverse event profile of RO5083945
    - determine the appropriate dose and regimen of RO5083945 to be used in Phase II
    - describe the pharmacodynamics of phosphorylated (p)EGFR, pAKT, pMAPK status of RO5083945 in skin biopsies and tumor biopsies
    - describe the PD of immune effector cell (CD16+ cells) status of RO5083945 in blood samples, skin biopsies and tumor biopsies
    - describe the FcγRIIIa-158 polymorphism
    - describe the preliminary anti-tumor activity of RO5083945
    Part II:
    - describe the anti-tumor activity of RO5083945 using:
    - ORR: including CR and PR
    - Duration of Response
    - PFS
    - describe the tolerability and adverse event profile of RO5083945
    - describe the PD of pEGFR, pAKT, pMAPK status of RO5083945 in skin biopsies and tumor biopsies
    - describe the PD of immune effector cell (CD16+ cells) status of RO5083945 in blood samples, skin biopsies and tumor biopsies
    - describe the FcγRIIIa-158 polymorphism
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Roche Sample Repository Research Project in association with protocol BO21495 open-label, multicenter, dose-escalation Phase I/II study to evaluate safety, pharmacokinetics and activity of RO5083945, a glycoengineered antibody against EGFR, in patients with metastatic and/or locally advanced malignant EGFR+ solid Tumors - Protocol B021495RG version A dated 29 January 2008.
    E.3Principal inclusion criteria
    Patients in both Part I and II of the study must meet the following criteria to be eligible
    for study entry:
    1. Signed informed consent
    2. Age ≥ 18 years
    3. ECOG Performance Status (PS) 0-1
    4. Able and willing to comply with protocol requirements
    5. Centrally confirmed EGFR expression in tumor tissue: ≥1% of tumor cells show
    membrane staining of any intensity
    6. Evidence of radiologically measurable or clinically evaluable disease
    7. Last dose of systemic anti-neoplastic therapy or radiotherapy ≥ 28 days prior
    to first RO5083945 infusion. Palliative radiotherapy for bone pain relief is
    allowed at any time before the first RO5083945 infusion.
    8. All acute toxic effects of any prior radiotherapy, chemotherapy or surgical
    procedure must have resolved to Grade ≤ 1, except alopecia and Grade 2
    peripheral neuropathy
    9. Neutrophil count of ≥ 1.5 x 109 cells/L, platelet count of ≥ 75 x 109/L, Hb ≥ 8
    g/dL
    10. Total bilirubin within normal limits (excluding Gilbert Syndrome)
    11. AST and/or ALT ≤ 2.5× ULN
    12. Serum creatinine ≤ 1.5 ULN
    13. Female patients of childbearing potential must commit to using a reliable and
    appropriate methods of contraception until at least two months after the end of
    study treatment. A serum pregnancy test should be performed within 7 days prior
    to the first dose of study treatment. Male patients with a partner of childbearing
    potential must agree to use a barrier contraception (condom) in addition to having
    their partner use another contraceptive method during the trial and for two months
    after the last dose. Reliable and appropriate methods of contraception include
    hormonal implants, oral contraceptives, intra-uterine devices or a barrier method
    used in conjunction with spermicidal jelly.
    Patients in Part I of the study must also meet the following criteria to be eligible for study
    entry:
    14. Histologically or cytologically confirmed advanced stage, primary or metastatic
    EGFR+ solid tumors
    15. No standard therapy exists
    Patients in Part II of the study must also meet the following criteria to be eligible for
    study entry:
    16. Histologically or cytologically confirmed advanced stage, primary or metastatic
    EGFR+ and mutant KRAS colorectal cancer
    17. Not more than 2 previous cytotoxic regimens for metastatic disease
    18. Evidence of radiologically measurable and documented progressive disease
    E.4Principal exclusion criteria
    The presence of any of the following criteria in both Part I and II will exclude a patient
    from the study:
    1. Concurrent therapy with any other investigational drug
    2. History of NCI CTCAE Grade 3-4 toxicity resulting from previous anti-EGFR
    treatment (Grade 4 for skin toxicity)
    3. Grade 3-4 peripheral neuropathy toxicity
    4. Pregnant or lactating women
    5. Known or suspected CNS metastases including leptomeningeal metastases
    6. Poorly controlled hypertension (systolic >180 mm Hg or diastolic > 100 mm Hg)
    7. Severe uncontrolled illness including poorly controlled diabetes mellitus, active or
    uncontrolled infection
    8. Known infection with HBV, HCV and HIV
    9. Any other diseases, metabolic dysfunction, physical examination finding, or
    clinical laboratory finding giving reasonable suspicion of a disease or condition
    that would contraindicate the use of an investigational drug
    10. Dementia or altered mental status that would prohibit informed consent
    11. Major surgery or significant traumatic injury < 28 days prior to the 1st
    RO5083945 infusion (excluding biopsies)
    Patients in Part II who also meet the following exclusion criteria will be excluded from
    the study:
    12. wild type KRAS colorectal cancer
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for Part I of the study will be the description of the PK and
    maximum tolerated dose (MTD), if achieved.
    The primary variable for Part II of the study will be the description of the Tumor Growth Control Rate (TGCR): CR, PR and SD > 2 months as well as safety profile.
    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 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analysis
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 EEA5
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    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 Decision2008-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-21
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