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    Summary
    EudraCT Number:2010-022951-49
    Sponsor's Protocol Code Number:20100007
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 ConcernedLatvia - SAM
    A.2EudraCT number2010-022951-49
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of survival benefit of panitumumab with supportive care to best supportive care alone in patients with metastatic colorectal cancer
    A.4.1Sponsor's protocol code number20100007
    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 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Information – Clinical
    B.5.3 Address:
    B.5.3.1Street Address240 Cambridge Science Park, Milton Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 0WD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailMedinfoInternational@amgen.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 Yes
    D.2.1.1.1Trade name Vectibix 20 mg/ml concentrate for solution for infusion
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.2Current sponsor codeAMG 954
    D.3.9.4EV Substance CodeSUB25390
    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) 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Chemorefractory, Wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS), Metastatic Colorectal Cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic Colorectal Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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 evaluate the effect of panitumumab and best supportive care (BSC) versus BSC alone on overall survival (OS) in subjects with chemorefractory wild-type exon 2 (codons 12 and 13) Kirsten rat sarcoma viral oncogene homolog (KRAS) mCRC
    E.2.2Secondary objectives of the trial
    To evaluate the treatment effect of panitumumab and BSC versus BSC alone in
    chemorefractory mCRC for:
    • Efficacy:
    o OS among subjects with wild-type RAS tumors (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or neuroblastoma RAS viral oncogene [NRAS])
    o Progression-free survival (PFS) among subjects with wild-type exon 2 (codons 12 and 13) KRAS tumors
    o PFS among subjects with wild-type RAS tumors (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or NRAS)
    o Objective response rate (ORR) among subjects with wild-type exon 2 (codons 12 and 13) KRAS tumors
    o ORR among subjects with wild-type RAS tumors (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or NRAS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    QTc Evaluation, date and version same as main protocol: To evaluate the electrocardiographic profile in a subset of subjects treated with
    panitumumab as an indicator of effect on cardiac repolarization.

    Pharmacogentic, date and version same as main protocol:To investigate the effect of genomic deoxyribonucleic acid (DNA) polymorphism in EGFR signaling pathway genes, drug metabolism genes, cancer genes, and drug target genes on efficacy.
    E.3Principal inclusion criteria
    4.1.1 Disease Related
    • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum
    - Metastatic disease
    • Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory (see Section 7.2)
    - KRAS mutational analysis may have been performed by the central
    laboratory prior to obtaining consent for study
    - Formalin-fixed paraffin-embedded tumor tissue from either the primary tumor or a metastatic lesion must be available and submitted to Amgen approved central laboratory for KRAS testing and/or other biomarker testing
    • ECOG performance status of 0, 1 or 2
    • At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization
    • Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
    - Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
    • Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
    4.1.2 Demographic
    • Man or woman ≥ 18 years of age
    4.1.3 Laboratory
    • Hematologic function, as follows: (≤ 10 days prior to randomization)
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - Platelet count ≥ 75 x 109/L
    - Hemoglobin ≥ 8.0 g/dL
    • Renal function, as follows: (≤ 10 days prior to randomization)
    - Creatinine ≤ 1.5 x ULN
    • Hepatic function, as follows: (≤ 10 days prior to randomization)
    - Aspartate aminotransferase (AST) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
    - Alanine aminotransferase (ALT) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
    - Total bilirubin ≤ 1.5 x ULN
    • Metabolic function, as follows: (≤ 10 days prior to randomization)
    - Magnesium ≥ lower limit of normal
    • Negative pregnancy test ≤ 72 hours before randomization (for women of childbearing potential only)
    4.1.4 Ethical
    • Subject or subject’s legally acceptable
    E.4Principal exclusion criteria
    4.2.1 Disease Related
    • Symptomatic brain metastases requiring treatment
    • History of other malignancy, except:
    - Malignancy treated with curative intent and with no known active disease present for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician
    - Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
    - Adequately treated cervical carcinoma in situ without evidence of disease
    - Prostatic intraepithelial neoplasia without evidence of prostate cancer
    4.2.2 Medications
    • Prior anti-EGFR antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
    • Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute toxicity
    • Radiotherapy ≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities
    4.2.3 General
    • Subject previously randomized to this study
    • Other investigational procedures ≤ 30 days before randomization
    • Subject currently enrolled in or ≤ 30 days from ending other investigational device or drug study(s)
    • Major surgery (eg, requiring general anesthesia) ≤ 28 days before randomization. Subjects must have recovered from any surgery related toxicities
    • Minor surgical procedure (eg, open biopsy) ≤ 7 days before randomization, or not yet recovered from prior minor surgery
    Note:uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis ≥ 3 days prior to randomization is acceptable
    • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months prior to randomization
    • History of interstitial lung disease (ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI
    • History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results
    • Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤ 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to randomization.
    • Subject pregnant or breast feeding, or planning to become pregnant during treatment and within 2 months after the end of treatment
    • Female subject of childbearing potential is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 2 months after the end of treatment
    • Known positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion)
    • Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days prior to randomization (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection)
    • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements
    4.2.4 Exclusion Criteria for QTc Evaluation Subpart of the Study
    The following exclusion criteria will only apply to subjects who are being considered for inclusion into the QTc evaluation subpart of the study. Subjects who meet the following criteria will not be eligible to participate in QTc evaluation subpart of the study.
    • Prolongation of QT/QTc interval > 450 milliseconds at screening
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival: time from randomization date to date of death for subjects with wild-type exon 2 (codons 12 and 13) KRAS
    E.5.1.1Timepoint(s) of evaluation of this end point
    When approximately 250 deaths are anticipated to be observed and at 24 months after last subject randomised if this occurs after 250 deaths observed
    E.5.2Secondary end point(s)
    To evaluate the treatment effect of panitumumab and BSC versus BSC alone in
    chemorefractory mCRC for:
    • Efficacy:
    o OS among subjects with wild-type RAS tumors (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or neuroblastoma RAS viral oncogene [NRAS])
    o Progression-free survival (PFS) among subjects with wild-type exon 2 (codons 12 and 13) KRAS tumors
    o PFS among subjects with wild-type RAS tumors (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or NRAS)
    o Objective response rate (ORR) among subjects with wild-type exon 2 (codons 12 and 13) KRAS tumors
    o ORR among subjects with wild-type RAS tumors (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS or NRAS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    When approximately 250 deaths are anticipated to be observed and at 24 months after last subject randomised if this occurs after 250 deaths observed
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Best Supportive Care alone
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    China
    Estonia
    Greece
    India
    Philippines
    Croatia
    Latvia
    Lithuania
    Malaysia
    Mexico
    Peru
    Romania
    Korea, Republic of
    Serbia
    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
    End of Study: The end of study will be the later of the Primary Completion (see definition below) or when the last subject discontinues the study treatment phase and has had the opportunity to complete the safety follow-up visit. (Primary Completion: The final analysis will occur approximately 24 months after the date the last subject is randomized or when approximately 250 deaths are observed, whichever is later)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 122
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 350
    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)
    Any subjects who remain on panitumumab treatment after all planned study analyses have been completed will be permitted to continue panitumumab treatment at the investigator’s discretion. All protocol required procedures and assessments, except biomarker exploratory assessments and long term follow-up assessments for survival, will continue to be performed as outlined in Section 7.1 and the Schedule of Assessments (see Appendix A) until disease progression, death, or withdrawal of consent.
    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 Decision2012-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-08
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