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    Summary
    EudraCT Number:2007-005690-59
    Sponsor's Protocol Code Number:Genmab A/S
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-23
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-005690-59
    A.3Full title of the trial
    A Dose-Escalation, Randomized Phase I/II trial of Zalutumumab - a Human Monoclonal Anti-EGF receptor Antibody - With or Without Irinotecan chemotherapy in Cetuximab refractory Colorectal Cancer patients Who Have Failed Standard Chemotherapy and Progressed During or Within 6 months of Stopping Cetuximab-Based Therapy.
    A.3.2Name or abbreviated title of the trial where available
    Zalutumumab with or without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
    A.4.1Sponsor's protocol code numberGenmab A/S
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 nameHuMax-EGFr (zalutumumab)
    D.3.2Product code HuMax-EGFr
    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 INNzalutumumab
    D.3.9.1CAS number 667901-13-5
    D.3.9.2Current sponsor codeHuMax-EGFr
    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
    Refractory Colorectal Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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
    Part 1
    • Evaluate the safety of escalating dose of zalutumumab in combination with irinotecan in patients with colorectal cancer (CRC) who have failed previous standard chemotherapy and who have progressed during or within 6 months of stopping treatment with cetuximab.
    Part 2
    • To investigate the efficacy of zalutumumab administered alone or in combination with irinotecan in patients with CRC who have failed previous standard chemotherapy and who have progressed during or within 6 months of stopping treatment with cetuximab.
    E.2.2Secondary objectives of the trial
    Secondary Objective
    • To determine the pharmacokinetic profile of zalutumumab administered alone or in combination with irinotecan
    • To evaluate potential biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and Females age ≥ 18 years.
    2. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
    3. Histologically or cytologically confirmed diagnosis of CRC.
    4. Documented disease progression (verified by CT scan and/or MRI according to RECIST) during or within 6 months of finishing cetuximab-based therapy
    • These images can be used as baseline for this protocol provided they were taken no more than 3 weeks prior to randomization
    5. The cumulative dose of cetuximab must be ≥ 1000mg/m2
    6. Failure and/or intolerance to standard chemotherapy
    7. Measurable disease defined as one or more target lesions according to RECIST.
    8. WHO performance status ≤ 2.
    9. Absence of KRAS mutation in the tumor specimen.
    E.4Principal exclusion criteria
    1. Prior treatment with anti-EGFR antibodies other than cetuximab
    2. Received the following treatments within 4 weeks prior to Visit 2:
    - Cytotoxic or cytostatic anti-cancer chemotherapy
    - Total resection or irradiation of the target lesion
    - Any investigational agent
    3. Diarrhea CTCAE > 1
    4. Skin rash CTCAE > 1
    5. Intolerance to irinotecan
    6. Past or current malignancy other than CRC, except for:
    - Cervical carcinoma Stage 1B or less
    - Non-invasive basal cell and squamous cell skin carcinoma
    - Malignant melanoma with a complete response of a duration of > 10 years
    - Other cancer diagnoses considered in remission for > 5 years
    7. Chronic or current infectious disease
    8. Known brain metastasis or leptomeningeal disease.
    9. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
    10. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease evaluated by the investigator interfere with effect of the study drug
    11. Expected survival < 3 months.
    12. Known HIV positive
    13. Known active hepatitis B and/or C
    14. Screening laboratory values:
    - WBC < 3.0 x109/L
    - Neutrophils < 1.5 x109/L
    - Platelets < 75 x109/L
    - ALAT > 5 times the upper limit of normal
    - ALP > 5 times the upper limit of normal (unless known bone metastases)
    - Bilirubin > 1.5 times the upper limit of normal
    - Creatinine > 1.5 the upper limit of normal.
    15. Current participation in any other interventional clinical study
    16. Patients known or suspected of not being able to comply with this trial protocol
    17. Breast feeding women or women with a positive pregnancy test at Visit 1.
    18. Male not willing to use adequate contraception during and 12 months after last dose of zalutumumab or women of childbearing potential not willing to use adequate contraception as hormonal birth control or intrauterine device, during study and 12 months after last dose of zalutumumab.
    19. Patients with known uncontrolled allergic conditions or allergy to the study drugs and/or their components.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    • Adverse events, clinical laboratory tests and vital signs
    Part 2
    • Objective Response Rate, defined as complete or partial response according to best overall response (verified by imaging technique and according to RECIST criteria).
    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 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) 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 Yes
    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) 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 No
    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 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
    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
    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 state97
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 97
    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 Decision2007-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
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