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    Summary
    EudraCT Number:2009-010715-32
    Sponsor's Protocol Code Number:20080763
    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:2009-10-01
    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 number2009-010715-32
    A.3Full title of the trial
    A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the
    Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code number20080763
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01001377
    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 Info – Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    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.3.9.4EV 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Erbitux 2mg/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Previously Treated, Wild-type 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
    The primary objective is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory mCRC among subjects with wild-type KRAS tumors.
    E.2.2Secondary objectives of the trial
    To compare the treatment effect of panitumumab versus cetuximab as treatment for chemorefractory mCRC among subjects with wild-type KRAS tumors:
    • Efficacy: progression-free survival (PFS), objective response rate (ORR), time to response, time to treatment failure, duration of response
    • Safety: subject incidence of AEs, significant laboratory changes and immunogenicity
    • Patient Reported Outcomes (PRO)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum Metastatic disease
    -Wild-type KRAS tumor status by protocol-specified testing (see Section 7.10) Formalin-fixed paraffin-embedded tumor tissue from either the primary tumor or a metastatic lesion must be submitted for biomarker testing (see Section 7.10)
    -ECOG performance status of 0, 1 or 2
    -Measurable or non-measurable disease per RECIST version 1.1
    -Must have failed 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. Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen
    -Subjects in whom relapse is diagnosed within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will be considered as having failed a prior regimen for metastatic disease
    -Must have previously received a thymidylate synthase inhibitor (e.g. fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
    -Man or woman ≥ 18 years of age
    -Hematologic function, as follows: (≤ 10 days prior to randomization)
    Absolute neutrophil count (ANC) ≥ 1.5 x 10 to the power of 9/L
    Platelet count ≥ 75 x 10 to the power of 9/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)
    -Competent to comprehend, sign, and date a written IEC/IRB approved informed consent form before any study-specific procedure
    E.4Principal exclusion criteria
    -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
    -Known hypersensitivity to any of the protocol-specified agents or their excipients
    -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, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization. Subjects must have recovered from any acute toxicity
    -Subject previously randomized to this study
    -Other investigational procedures ≤ 30 days before randomization
    -Subject currently is 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
    -Clinically significant cardiovascular disease (as defined by: unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
    -Myocardial infarction within last 6 months before randomization
    -History of interstitial lung disease (ILD), eg, interstitial pneumonitis, pulmonary fibrosis or evidence of interstitial lung disease 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(s) administration or may interfere with the interpretation of the results
    -Subject pregnant or breast feeding, or planning to become pregnant during treatment and within 6 months after the end of treatment
    -Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for an additional 6 months (males and females) 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 infections ≤14 days prior to randomization
    -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
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS): time from randomization date to date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will occur when approximately 752 deaths are anticipated to be observed;
    E.5.2Secondary end point(s)
    • Progression free survival (PFS): time from randomization date to date of disease progression per the RECIST version 1.1 or death. Subjects alive and not meeting criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
    • Overall Response Rate (ORR): The incidence of either a complete response (CR) or partial response (PR) per RECIST version 1.1 (responder). All subjects that do not meet the criteria for an
    objective response by the analysis cutoff date will be considered non-responders.
    • Duration of response: (calculated only for those subjects with an objective response) time from first objective response to disease progression per the RECIST v1.1. Subjects not meeting criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
    • Time to response: time from randomization date to date of first objective response. Non-responders by the analysis data cutoff date with a best response of SD will be censored at their last assessment of SD, and subjects with all other categories of best response will be censored at the maximum observed time to a first confirmed
    response among all responders.
    • Time to treatment failure: time from randomization date to date that decision was made to end the treatment period for any reason; subjects who remain in the treatment period at the time of analysis will be censored at the date of the last on study assessment.
    • Patient-reported outcomes (PRO):
    − HRQOL:
    􀂃 EQ-5D Health Index Scale
    􀂃 EQ Visual Analog Scale
    − CRC Symptomatology
    􀂃 NCCN FACT Colorectal Symptom Index (FCSI)
    • Incidence of AEs, significant laboratory changes and immunogenicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis will occur when approximately 752 deaths are anticipated to be 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA64
    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
    Australia
    Canada
    China
    Hong Kong
    India
    Israel
    Malaysia
    Mexico
    Peru
    Philippines
    Russian Federation
    Serbia
    Singapore
    South Africa
    Taiwan
    Turkey
    United States
    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
    Primary Completion: the time when the last subject is assessed or receives an intervention for the purposes of final collection of data for the primary endpoint of overall survival.
    End of Study: the time when the last subject is assessed or receives an intervention for evaluation in the study (eg, safety follow up or survival assessment beyond the Primary Completion defined above).
    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 months0
    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 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 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: 680
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 342
    F.4.2.2In the whole clinical trial 1000
    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 treatment after all planned study analyses have been completed will be permitted to continue treatment at the investigator’s discretion. All protocol required procedures and assessments, except PRO assessments and long term follow- up assessments for survival, will continue to be performed as outlined in Section 7.5 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 Decision2009-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-07
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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