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    Summary
    EudraCT Number:2010-023671-26
    Sponsor's Protocol Code Number:PARLIM
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-21
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2010-023671-26
    A.3Full title of the trial
    Panitumumab after Resection of Liver Metastases from Colorectal Cancer in RAS Wild-type Patients
    -PARLIM-
    Panitumumab nach Resektion von Lebermetastasen des kolorektalen Karzinoms bei Patienten mit RAS Wildtyp
    - PARLIM -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Panitumumab after Resection of Liver Metastases from Colorectal Cancer in RAS Wild-type Patients
    -PARLIM-
    Panitumumab nach Resektion von Lebermetastasen des kolorektalen Karzinoms bei Patienten mit RAS Wildtyp
    - PARLIM -
    A.3.2Name or abbreviated title of the trial where available
    PARLIM
    A.4.1Sponsor's protocol code numberPARLIM
    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 SponsorKlinikum der Universität München-Großhadern
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLMU München
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAmgen GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Universität München-Großhadern
    B.5.2Functional name of contact pointStudy office
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistraße 15
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number498970952208
    B.5.5Fax number498970955256
    B.5.6E-mailMatthias.Wolff@med.uni-muenchen.de
    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
    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 namePanitumumab
    D.3.2Product code Panitumumab
    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 codePanitumumab
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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
    Patients with metastatic colorectal cancer confined to the liver who underwent R0/1 resection of liver metastases
    Patienten mit metastasierten Kolorektalkarzinoms mit Beschränkung auf die Leber mit einer R0/1 Resektion der Lebermetastasen
    E.1.1.1Medical condition in easily understood language
    metastatic colorectal cancer confined to the liver
    Dickdarmkrebs mit Metastasen in der Leber
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 study aims to assess the efficacy of postoperative therapy with FOLFOX plus panitumumab followed by maintenance with panitumumab for 3 months in RAS wild-type patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are verified by a randomised control group without the antibody.
    Die Studie hat das Ziel, die Wirksamkeit der postoperativen Therapie mit FOLFOX plus Panitumumab gefolgt von einer
    3-monatigen Erhaltungstherapie mit Panitumumab bei Patienten mit RAS-Wildtyp zu untersuchen und mit den
    historischen Daten für die Standard-FOLFOXChemotherapie, die anhand der randomisierten Kontrollgruppe ohne den Antikörper verifiziert wird, zu vergleichen.
    E.2.2Secondary objectives of the trial
    The study aims to investigate the tolerability of panitumumab-based therapy in the postoperative setting. In addition, predictors of treatment efficacy shall be identified by an evaluation of the molecular pathology of the disease.
    Die Studie hat das Ziel, die Verträglichkeit der Panitumumab-basierten Therapie in einem postoperativen Setting zu untersuchen. Zusätzlich sollen Prädiktoren für die Behandlungswirksamkeit durch die Auswertung der molekularen Pathologie der Erkrankung identifiziert werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has provided written informed consent.
    2. R0/1-resection of liver metastasis, at least four weeks but not longer than 8 weeks ago (submission of the pathologist´s report to exclude R2 resection status is mandatory for randomisation)
    3. Histologically confirmed diagnosis of metastatic colorectal cancer confined to the liver
    4. RAS wild-type of the tumor, tested in:
    • KRAS exon 2 (codons 12/13)
    • KRAS exon 3 (codons 59/61)
    • KRAS exon 4 (codons 117/146)
    • NRAS exon 2 (codons 12/13)
    • NRAS exon 3 (codons 59/61)
    • NRAS exon 4 (codons 117/146)
    5. Age 18 years or older
    6. ECOG performance status 0-1
    7. Females with child-bearing potential must use adequate contraceptive measures
    8. Exclusion of pregnancy
    9. Relevant toxicities of previous treatments must have subsided
    10. Magnesium ≥ lower limit of normal; Calcium ≥ lower limit of normal
    11. Normal cardiac function demonstrated by ECG and echocardiogram (LVEF ≥ 55%)
    • No symptomatic congestive heart failure
    • No unstable angina pectoris
    • No cardiac arrhythmia
    12. Adequate organ function as defined by Table 1:
    Table 1: Adequate Hepatic and Renal Function Values
    SYSTEM LABORATORY VALUES
    Hematologic
    ANC (absolute neutrophil count) ≥ 1.5 G/L
    Leucocytes > 3.0 G/L
    Hemoglobin ≥ 9 g/dL
    Platelets ≥ 100 G/L
    Hepatic
    Albumin ≥ 2.5 g/dL
    Serum bilirubin <=2 mg/dL
    AST and ALT <= 3 x ULN
    Renal
    Serum Creatinine <= 1.5 mg/dL
    1. schriftliche Einverständniserklärung
    2. R0/1-Resektion von Lebermetastasen, die mindestens vier Wochen aber nicht länger als 8 Wochen zurückliegt
    3. Histologisch bestätigte Diagnose eines metastasierten Kolorektalkarzinoms mit Beschränkung auf die Leber
    4. RAS- Wildtyp des Tumors, getestet in:
    • KRAS exon 2 (codons 12/13)
    • KRAS exon 3 (codons 59/61)
    • KRAS exon 4 (codons 117/146)
    • NRAS exon 2 (codons 12/13)
    • NRAS exon 3 (codons 59/61)
    • NRAS exon 4 (codons 117/146)
    5. Alter ≥ 18 Jahre
    6. ECOG Performance-Status 0-1
    7. Frauen im gebärfähigen Alter müssen geeignete Verhütungsmethoden anwenden
    8. Ausschluss einer Schwangerschaft
    9. Relevante Toxizitäten vorheriger Behandlungen müssen abgeklungen sein
    10. Magnesium ≥ untere Normwertgrenze; Kalzium ≥ untere Normwertgrenze
    11. Durch EKG und Echokardiogramm bestätigte normale kardiale Funktion (LVEF ≥ 55%)
    12. Adäquate Organfunktion
    E.4Principal exclusion criteria
    1. Known manifestations of metastatic disease
    2. Progression during preoperative treatment
    3. RAS mutation of the tumor
    4. Contraindication against therapy with 5-Fluorouracil/ folinic acid or oxaliplatin
    5. Known intolerability of panitumumab
    6. Known DPD deficiency
    7. Polyneuropathy > grade 1 (NCI-CTCv4) which precludes the use of oxaliplatin
    8. Evidence of ascites or cirrhosis
    9. Patient is pregnant or lactating or planning to become pregnant within 6 months after end of treatment
    10. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
    11. Has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrolment, or there is an anticipated need for major surgical procedure during the course of the study. This excludes minor surgical procedures like implantation of intravenous portsystems (7 days prior enrolment) or central venous catheters (2 days prior enrolment).
    12. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrolment/randomisation
    13. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
    14. Has a concurrent disease or condition that would make the subject inappropriate for study participation or would interfere with the subject’s safety.
    15. Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
    16. Requires concurrent cancer therapy (chemotherapy, radiation therapy, biologic therapy, immunotherapy, or hormonal therapy) while on study.
    17. Requires concurrent treatment with an investigational agent, participation in another clinical trial, or any specifically prohibited medication while on study.
    18. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to 5-Fluorouracil, folinic acid, oxaliplatin, or panitumumab.
    19. Other active malignancy
    20. Known alcohol abuse or drug addiction
    21. Incapability to give informed consent
    1. Bekannte Manifestation von Metastasen
    2. Progression während der präoperativen Behandlung
    3. RAS-Mutation des Tumors
    4. Kontraindikation gegen eine Behandlung mit 5-Fluorouracil/ Folinsäure oder Oxaliplatin
    5. Bekannte Unverträglichkeit von Panitumumab
    6. Bekannter DPD-Mangel
    7. Polyneuropathie > Grad 1 (NCI-CTCv4), welche die Anwendung von Oxaliplatin ausschließt
    8. Nachweis von Aszites oder Zirrhose
    9. Patient ist schwanger oder stillt oder plant innerhalb von 6 Monaten nach Ende der Behandlung schwanger zu werden
    10. Teilnehmer (männlich oder weiblich) ist nicht willens während oder bis zu 6 Monate nach der Behandlung (männlich oder weiblich) eine hochwirksame Verhütungsmethode (gemäß Standard der Einrichtung) zu verwenden
    11. Operation, offene Biopsie oder signifikante traumatische Verletzung innerhalb von 28 Tagen vor Studieneinschluss oder geplante Operation im Verlauf der Studie. Kleinere chirurgische Eingriffe wie die Implantation von intravenösen Portsystemen (7 Tage vor Studieneinschluss) oder von zentralen Venenkathedern (2 Tage vor Studieneinschluss) sind davon ausgenommen.
    12. Klinisch signifikante kardiovaskuläre Erkrankung (einschließlich Myokardinfarkt, instabile Angina pectoris, symptomatische kongestive Herzinsuffizienz, schwerwiegende unkontrollierte kardiale Arrhythmien) ≤1 Jahr von Einschluss/Randomisierung
    13. Anamnese einer interstitiellen Lungenerkrankung z.B. Pneumonitis oder pulmonale Fibrose oder Nachweis einer interstitiellen Lungenerkrankung in der Baseline-Thorax-Aufnahme
    14. Gleichzeitige Erkrankung oder Zustand, durch welchen der Teilnehmer nicht geeignet ist für die Studienteilnahme oder welcher sich auf die Sicherheit des Teilnehmers auswirkt.
    15. Psychologische, familiäre, soziologische oder geographische Bedingungen, die eine Einhaltung des Protokolls nicht erlauben .
    16. Gleichzeitige Krebstherapie (Chemotherapie, Bestrahlung, biologische Therapie, Immuntherapie oder hormonale Therapie) während der Studie.
    17. Gleichzeitige Behandlung mit einem Prüfpräparat, Teilnahme an einer anderen klinischen Studie oder jegliche ausdrücklich verbotene Medikation während der Studie.
    18. Bekannte sofortige oder verzögerte Überempfindlichkeitsreaktion oder Idiosynkrasie auf chemisch verwandte Arzneimittel zu 5-Fluorouracil, Folinsäure, Oxaliplatin oder Panitumumab.
    19. Andere aktive Malignität
    20. Bekannter Alkoholabusus oder Drogensucht
    21. Unfähigkeit die Einwilligungserklärung zu erteilen
    E.5 End points
    E.5.1Primary end point(s)
    • Progression-free survival (PFS) rate at 2 years after randomisation
    Progressionsfreies Überleben (PFS) 2 Jahre nach der Randomisierung
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after randomisation
    2 Jahre nach der Randomisierung
    E.5.2Secondary end point(s)
    • Treatment tolerability and side effects
    • Overall survival
    • Verträglichkeit und Nebenwirkungen
    • Gesamtüberleben
    E.5.2.1Timepoint(s) of evaluation of this end point
    • after end of chemotherapy (3 month) in both arms
    • after end of maintainance (6 month) in experimental arm only
    • nach dem Ende der Chemotherapie (3 Monate) in beiden Armen
    • nach dem Ende der Erhaltungstherapie (6 month) im experimentellen Arm
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    backbone chemotherapy + panitumumab compared with backbone chemotherapy only
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    Last follow up visit of the last subject
    Letzte Nachfolgeuntersuchung des letzten Studienpatienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months10
    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.1.3Elderly (>=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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 111
    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)
    After the end of the treatment in the study the subjects are treated at investigators discretion.
    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 Decision2015-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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