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    Summary
    EudraCT Number:2005-004676-20
    Sponsor's Protocol Code Number:20050181
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2005-004676-20
    A.3Full title of the trial
    A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code number20050181
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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 namePanitumumab
    D.3.2Product code AMG954
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeAMG954
    D.3.9.3Other descriptive namePanitumumab
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Patients with Previously Treated Metastatic Colorectal Cancer
    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 evaluate the treatment effect of panitumumab plus FOLFIRI on overall survival(OS) and progression-free survival (PFS) compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.
    E.2.2Secondary objectives of the trial
    To evaluate objective response rate (ORR), time to progression (TTP), duration of
    response (DOR), and safety (incidence of AEs and significant laboratory changes).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
    • One and only one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based
    chemotherapy is allowed)
    • Radiographically documented disease progression per modified RECIST criteria either while receiving or ≤ 6 months after the last dose of prior first-line fluoropyrimidine-based chemotherapy for mCRC
    • At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria. (All sites of disease must be evaluated ≤ 28 days prior to enrollment)
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    • Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses of EGFr and biomarker testing
    • Man or woman ≥ 18 years of age
    • Hematologic function, as follows (≤ 7 days of randomization):
    o Absolute neutrophil count (ANC) ≥ 1.5 x
    109/L
    o Platelet count ≥ 100 x 109/L
    o Hemoglobin ≥ 9 g/dL
    • Renal function, as follows (≤ 7 days of randomization):
    o Creatinine ≤ 1.5 x upper limit of normal
    (ULN)
    • Hepatic function, as follows (≤ 7 days of randomization):
    o Aspartate aminotransferase (AST) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
    o Alanine aminotransferase (ALT) ≤ 3 x ULN(if liver metastases ≤ 5 x ULN)
    o Total bilirubin ≤ 1.5 x ULN
    • Metabolic function, as follows (≤ 7 days of randomization):
    o Magnesium ≥ lower limit of normal
    • Negative pregnancy test ≤ 72 hours of randomization (females of childbearing
    potential only)
    • Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form
    • Life expectancy ≥ 3 months
    E.4Principal exclusion criteria
    • History or known presence of central nervous system (CNS) metastases
    • History of another primary cancer, except:
    o Curatively treated in situ cervical cancer, or
    o Curatively resected non-melanoma skin cancer, or
    o Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomization
    • Prior irinotecan therapy
    • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)
    • Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before randomization
    • Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for randomization
    • Radiotherapy ≤ 14 days prior to randomization. Patients must have recovered from all radiotherapy-related toxicities
    • Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days prior to randomization
    • CYP3A4 enzyme inducing anti-convulsant medication (eg phenytoin, phenobarbital or carbamazepine), rifampin and rifabutin, and St. John’s Wort ≤ 14 days before randomization
    • Ketoconazole ≤ 7 days before randomization (Itraconazole should be used with caution)
    • Any investigational agent or therapy ≤ 30 days before randomization
    • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before randomization
    • Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin
    • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
    • Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > CTC grade 2 [CTCAE version 3.0])
    • Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C
    virus, acute or chronic active hepatitis B infection
    • Any co-morbid disease or condition that could increase the risk of toxicity (eg dihydropyrimidine deficiency, significant ascites or pleural effusion)
    • Any uncontrolled concurrent illness or history of any medical condition that may interfere with the interpretation of the study results
    • Major surgical procedure (requiring general anesthesia) ≤ 28 days or minor surgical procedure (excluding central venous catheter placement) ≤ 14 days before randomization. Patients must have recovered from surgery related toxicities
    • Subject who is pregnant or breast feeding
    • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions ie. double barrier contraceptive methods (eg diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men
    • Subject unwilling or unable to comply with study requirements
    • Previously randomized into this study protocol
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Overall survival (OS) and progression free survival (PFS)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Subjects with evidence of disease progression will be discontinued from treatment dosing and will be followed for safety (30 ± 3 days after the last study drug administration) and survival (every 3 months ± 28 days until up to 30 months after the last subject is randomized).
    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 months50
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months50
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 635
    F.4.2.2In the whole clinical trial 1100
    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 Decision2006-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-13
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