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    Summary
    EudraCT Number:2009-011899-30
    Sponsor's Protocol Code Number:20080259
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-25
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-011899-30
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim
    Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
    A.4.1Sponsor's protocol code number20080259
    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 SponsorAmgen Inc
    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 Yes
    D.2.1.1.1Trade name Neulasta
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNeulasta
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegfilgrastim
    D.3.9.3Other descriptive nameNeulasta
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally-advanced or Metastatic Colorectal Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic 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
    To evaluate the efficacy of pegfilgrastim, as compared with placebo in reducing the
    incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed,
    locally-advanced or metastatic colorectal cancer treated with bevacizumab and either
    FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature ≥ 38.0°C (≥ 100.4°F)
    and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24 hour
    window of a temperature ≥ 38.0°C or (≥ 100.4°F).
    E.2.2Secondary objectives of the trial
    To estimate the effects, if any, of pegfilgrastim on the efficacy of bevacizumab and
    chemotherapy compared with placebo as evaluated by overall survival (OS),
    progression-free survival (PFS), and overall response rate (ORR).
    To characterize the incidence of grade 4 FN, grade 3/4 neutropenia and grade 4
    neutropenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease-related
    • Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum
    • Locally-advanced or metastatic disease by radiographic evaluation (CT, MRI)
    − Measurable disease as defined by revised RECIST Criteria (v1.1) criteria (see
    Appendix F)
    • Subject has not previously received chemotherapy for locally-advanced or metastatic CRC
    − Subject may have received adjuvant therapy for primary colorectal cancer
    provided that at least 6 months have elapsed from the time the adjuvant therapy
    was concluded and recurrent/metastatic disease was documented. It is
    recommended that if progression occurred after 6 months but within 12 months
    following completion of adjuvant FOLFOX chemotherapy, subjects should
    receive FOLFIRI + bevacizumab as first-line chemotherapy, and vice versa. If
    > 12 months has elapsed before progression occurs, subjects may receive
    FOLFOX + bevacizumab or FOLFIRI + bevacizumab at physician’s discretion,
    regardless of what was received adjuvantly.
    • ECOG performance status 0-2 (see Appendix E)
    Demographic
    • Age of 18 years or over
    Laboratory
    Adequate organ and marrow function as defined below:
    • Absolute neutrophil count (ANC) at least 1.5 x 109/L
    • Platelet count at least 100 x 109/L
    • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    or AST and ALT ≤ 5.0 x ULN if attributable to liver metastasis
    • Partial thromboplastin time (PTT) ≤ 1.0 x ULN and international normalized ratio
    (INR) ≤ 1.5, unless subject is on full dose anticoagulation therapy. Subjects on full
    dose anticoagulation are eligible if the following criteria are met:
    − The subject has an in-range INR (usually between 2 and 3) on a stable dose of
    oral anticoagulant or be on a stable dose of low molecular weight heparin
    − The subject has no active bleeding or pathological condition that carries high risk
    of bleeding (eg, tumor involving major vessels or known varices)
    • Creatinine ≤ 1.5 times ULN
    General
    • Written informed consent obtained
    • Afebrile on day 1 of cycle 1
    • Must be able and willing to comply with study and/or follow-up procedures
    E.4Principal exclusion criteria
    Disease-related
    • Known brain metastases
    • History of another primary malignancy less than/equal to 5 years prior to
    randomization, with the exception of non-melanoma skin cancer, carcinoma in situ of
    uterine cervix, and prostatic intraepithelial neoplasia without evidence of prostate
    cancer
    • Prior major surgical procedure less than 28 days prior to day 1 of cycle 1
    chemotherapy dosing); anticipated need for major surgical procedure during the
    4 cycle treatment period of the study
    • Fine needle aspirations or core biopsies within 7 days prior to day 1 of cycle 1
    chemotherapy dosing (eg. implantation of venous access device, fine needle
    aspirations, or core biopsies)
    • Serious nonhealing wound, ulcer, or bone fracture, or history of abdominal fistula,
    gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to
    day 1 of cycle 1
    • Uncontrolled high blood pressure, history of labile hypertension, uncontrolled
    congestive heart failure, unstable angina within the past 3 months, myocardial
    infarction or history of stroke within the past 12 months, unstable symptomatic
    arrhythmia requiring medication, or clinically significant peripheral vascular disease
    • History of clinically significant bleeding within 6 months prior to randomization
    • History of arterial or venous thromboembolism within 6 months prior to randomization
    • History of other disease including uncontrolled diabetes, serious active or
    uncontrolled infection, metabolic dysfunction; physical examination finding, or clinical
    laboratory finding giving reasonable suspicion of a disease or condition that
    contraindicates the use of the prescribed therapy or that might affect the
    interpretation of the results of the study or render the subject at high risk from
    treatment complications
    Laboratory
    • Proteinuria > 1+, or total quantitative protein > 500 mg protein/day as determined by 24-hr urine collection
    Medications
    • Prior radiotherapy unless treatment was limited to the target lesion and only 1
    measurable lesion was treated. Progression of the irradiated lesion must be
    demonstrated. Subjects may not have received prior radiotherapy to greater than
    25% of bone marrow. Radiation must have concluded ≥ 4 weeks prior to enrollment.
    − Radiotherapy to non-target lesions for pain control will be allowed
    • Prior bevacizumab use or other agents targeting VEGF
    • Concurrent use of other biological agents
    • Use of systemic anti-infectives for active infection, during the 3 calendar days before starting study chemotherapy and bevacizumab or planned during the study treatment period
    General
    • Current, recent (within 4 weeks of the first infusion of this study), or planned
    participation (during the study treatment period) in an experimental therapeutics
    study other than this protocol
    • Female subjects who are pregnant or lactating or men and women of reproductive
    potential not willing to employ an effective method of birth control during treatment
    and for 20 weeks for women, and 30 weeks for men after discontinuing study
    treatment
    • History of allergic reactions attributed to compounds of similar chemical or biologic
    composition to bevacizumab, irinotecan, 5-FU, oxaliplatin, or leucovorin, including
    known sensitivity to E.Coli derived products (eg, Filgrastim, HUMULIN insulin,
    L-asparaginase)
    • Known dihydropyrimidine dehydrogenase deficiency
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of grade 3/4 FN during the study treatment period.
    The study will evaluate whether adding pegfilgrastim can reduce the incidence of grade 3/4 FN in first-line CRC patients receiving the combination of chemotherapy and bevacizumab. The study is designed to have at least 90% power at the two-sided 0.05 significance level to detect an absolute reduction of subject incidence of grade 3/4 FN from 9% to 3%, which is approximately 66.7% relative reduction.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    The end of the study is defined as when the last-enrolled participating subject completes the 36-month long-term follow-up period, or discontinues the study due to death, loss to follow-up, or study consent withdrawal.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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 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 400
    F.4.2.2In the whole clinical trial 800
    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 Decision2009-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-02
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