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    Summary
    EudraCT Number:2011-005471-17
    Sponsor's Protocol Code Number:RASH
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-005471-17
    A.3Full title of the trial
    Phase II Study for the Evaluation of the Efficacy of Gemcitabine plus Erlotinib in Rash-positive Patients with metastatic pancreatic cancer and good risk factors
    Phase II Studie zur Bestimmung der Effektivität von Gemcitabin plus Erlotinib bei Rash-positiven Patienten mit metastasiertem Pankreaskarzinom und günstigen Risikofaktoren
    A.4.1Sponsor's protocol code numberRASH
    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.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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGemcitabine
    D.3.2Product code Gemcitabine
    D.3.4Pharmaceutical form
    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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib
    D.3.2Product code Erlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib
    D.3.2Product code Erlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 4
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib
    D.3.2Product code Erlotinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 name5-Fluorouracil
    D.3.4Pharmaceutical form
    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 INNFLUOROURACIL
    D.3.9.1CAS number 51-21-8
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 6
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameLeukovorin
    D.3.4Pharmaceutical form
    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.3.9.1CAS number 58-05-9
    D.3.9.3Other descriptive nameFOLINIC ACID
    D.3.9.4EV Substance CodeSUB13910MIG
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 7
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameIrinotecan
    D.3.4Pharmaceutical form
    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.3.9.1CAS number 136572-09-3
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02772MIG
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 8
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameOxaliplatin
    D.3.4Pharmaceutical form
    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 INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    metastatic pancreatic carcinoma
    metastasiertes Pankreaskarzinom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10033576
    E.1.2Term Pancreas carcinoma
    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
    1-year survival rate of "good risk" patients who develop Rash under treatment with gemcitabine/erlotinib
    1-Jahresüberlebensrate von „good-risk“ Patienten, die unter einer Behandlung mit Gemcitabin/Erlotinib einen Rash entwickeln.
    E.2.2Secondary objectives of the trial
    - evaluation of therapeutic efficacy parameter (ORR, DCR, PFS, OS) in Rash-positive and –negative patients
    - tolerability
    -- assessment according NCI-CTCAE v4.0
    -- evaluation of the cutaneous side effects including weekly photodocumentation (within the first 4 weeks) and every 4 weeks during the following treatment
    - translational project
    -- evaluation of EGFR-associated singnal transduction parameters
    -- evaluation of molecular biology parameters of skin toxicity
    -- photodocumentation of erlotinib-associated skin toxicity, central evaluation and correlation with clinical and molecular biological parameters
    - Evaluation von Parametern der therapeutischen Effektivität (ORR, DCR, PFS, OS) bei Rash-positiven und -negativen Patienten
    - Verträglichkeit
    -- Bewertung anhand der NCI-CTCAE v4.0
    -- Die Evaluation der kutanen Nebenwirkungen inklusive bildlicher Dokumentation erfolgt wöchentlich innerhalb der ersten 4 Wochen, danach alle 4 Wochen.
    - Translationales Projekt
    -- Evaluation von Parametern der EGFR-assoziierten Signaltransduktion
    -- Evaluation von molekularbiologischen Parametern der Hauttoxizität
    -- Fotodokumentation der Hauttoxizität durch Erlotinib, zentrale Auswertung und Korrelation mit klinischen und molekularbiologischen Parametern
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically (not cytologically) confirmed metastatic adenocarcinoma of the pancreas (UICC stadium IV; any T, any N, M1 following TNM)
    - At least one measurable tumor lesion (CT or MRI) according to RECIST version 1.1
    - ECOG PS 0 and 1
    - between 18 and 75 years of age
    - bilirubin ≤ 1.5 ULN (biliary duct stent in absence of cholangitis is no contraindication)
    - availability of tumor samples (no cytological samples)
    - written informed consent in collection of tumor- and blood samples for translational research according to study protocol
    - a minimum of 3 month life expectancy
    - written informed consent
    - a negative pregnancy test result within 7 days prior start of study treatment for women of childbearing potential
    - sufficient renal-, liver- and bone marrow function.
    -- ANC * 1,5 x 109/l
    -- haemoglobin * 8 g/dl
    -- thrombocytes * 100 x 109/l
    -- serum creatinine * 1,25 x ULN
    -- transaminases * 2,5 x ULN
    (in case of liver metastases < 5-fach ULN)
    -- creatinine clearance ≥30 ml/min
    - legally competent study participant
    - ability of regular continuous long-term follow up
    - Histologisch (nicht zytologisch) gesichertes metastasiertes Adenokarzinom des Pankreas (Stadium IV nach UICC; jedes T, jedes N, M1 nach TNM)
    - Mindestens eine messbare Tumorläsion (CT oder MRT) nach RECIST Version 1.1
    - ECOG PS 0 und 1
    - Alter zwischen 18 und 75 Jahren
    - Bilirubin ≤ 1,5 ULN (ein liegender Gallenwegsstent stellt in Abwesenheit einer Cholangitis keine Kontraindikation dar)
    - Verfügbarkeit von Tumorproben (keine zytologischen Proben)
    - Schriftliches Einverständnis des Patienten in die Sammlung von Tumor- und Blutproben für translationale Untersuchungen entsprechend dem Studienprotokoll
    - Mindestens dreimonatige Lebenserwartung
    - Unterschriebene Patienteneinverständniserklärung
    - Ein negativer Schwangerschaftstests bei Frauen im gebärfähigen Alter muss 7 Tage vor Start der Behandlung durchgeführt worden sein
    - Ausreichende Nieren-, Leber- und Knochenmarkfunktion:
    -- absolute Neutrophilenzahl * 1,5 x 109/l
    -- Hämoglobin * 8 g/dl
    -- Thrombozyten * 100 x 109/l
    -- Serumkreatinin * 1,25 x ULN
    -- Transaminasen * 2,5 x ULN
    (bei Lebermetastasen < 5-fach ULN)
    -- Kreatininclearance ≥30 ml/min

    - Geschäftsfähigkeit des Patienten
    - Möglichkeit der regelmäßigen längerfristigen Nachsorge
    E.4Principal exclusion criteria
    - resectable pancreatic carcinoma
    - locally advanced pancreatic carcinoma (non-resectable tumor without distant metastases)
    - prior palliative chemotherapy of the metastatic or locally advanced, non-resectable pancreatic carcinoma
    - prior palliative radiotherapy of the metastatic or locally advanced, non-resectable pancreatic carcinoma
    - radiotherapy within four weeks prior randomization or radiation of target lesions
    - adjuvant chemo- or radiochemotherapy of the pancreatic carcinoma ≤ six month prior randomisation
    - any malignant metastatic disease and any curatively treated neoplasia diagnosed within the last five years prior randomisation
    - major surgical intervention within the last two weeks prior randomisation
    - chronic diarrhea
    - known deficiency of glucuronidation (Gilbert-Meulengracht syndrome)
    - acute or subacute ileus or inflammatory bowel disease
    - pre-existing polyneuropathy > grade 1 regarding NCI-CTCAE v4.0
    - severe concomitant disease that compromise eligibility and safety of the patient within the study, e.g. active infections or hepatic, renal or metabolic diseases
    - clinically significant cardiovascular disease within the last twelve month prior randomisation (e.g. instable A. pectoris, myocardial infarction, cardiac insufficiency NYHA ≥ II, arrhythmias requiring treatment)
    - any psychological, familial, sociological or geographic condition that do not permit adherence to the study protocol
    - untreated, symptomatic brain metastases (except the patient has undergone successful local therapy of the central brain metastases and no need for treatment with corticosteroids for at least four weeks prior randomisation. Radiological investigations to exclude brain metastases are mandatory only for symptomatic, but not for asymptomatic patients)
    - known DPD deficiency
    - concomitant therapy with the virostatics Sorivudin or its chemical relative Brivudin
    - preganant or breast feeding women; non-effective contraception in men and pre-menopausal women (an effective method of contraception has a Pearl index of < 1)
    - participation in another study within the last 28 days prior randomisation and during study participation
    - hypersensitivity to any substance or other components used in this study
    - former or ongoing keratitis or ulcerative keratitis or existence of severe dryness of the eyes
    - Resektables Pankreaskarzinom
    - Lokal fortgeschrittenes Pankreaskarzinom (nicht resektabler Tumor ohne Fernmetastasen)
    - Vorangegangene palliative Chemotherapie für das metastasierte oder das lokal fortgeschrittene, nicht resektable Pankreaskarzinom
    - Vorangegangene palliative Strahlentherapie oder Radiochemotherapie für das lokal fortgeschrittene, nicht resektable Pankreaskarzinom
    - Strahlentherapie innerhalb von vier Wochen vor Studieneinschluss oder Bestrahlung der Indikatorläsionen
    - Adjuvante Chemotherapie oder Radiochemotherapie für das Pankreaskarzinom ≤ 6 Monate vor Studieneinschluss
    - Alle im Vorfeld aufgetretenen metastasierten Tumorerkrankungen sowie alle kurativ behandelten Neoplasien, die innerhalb der letzten fünf Jahre vor Studieneinschluss diagnostiziert wurden
    - Größere operative Maßnahme innerhalb der letzten zwei Wochen vor Studienstart
    - Chronische Diarrhö
    - Bekannter Glucuronidierungs-Defekt (Gilbert-Meulengracht-Syndrom)
    - Akuter oder subakuter Ileus oder chronisch entzündliche Darmerkrankungen
    - Vorbestehende Polyneuropathie > Grad I nach NCI-CTCAE v4.0
    - Schwerwiegende Begleiterkrankungen, welche die Eignung und Sicherheit des Patienten im Rahmen der Studie beeinträchtigen wie aktive Infektionen, hepatische, renale oder metabolische Erkrankungen
    - Klinisch signifikante kardiovaskuläre Erkrankungen innerhalb der letzten 12 Monate vor Studienstart (z.B. instablie A. pectoris, Myokardinfarkt, Herzinsuffizienz NYHA ≥ II, behandlungsbedürftige Arrhythmien)
    - Jede psychologische, familiäre, soziologische oder geographische Begebenheit, die eine Einhaltung des Studienprotokolls nicht zulässt
    - Unbehandelte, symptomatische Hirnmetastasen (außer der Patient hat sich einer erfolgreichen lokalen Therapie seiner zentralen Hirnmetastasen unterzogen und ist seit mindestens 4 Wochen ohne Behandlung mit Kortikosteroiden. Untersuchungen mit bildgebenden Verfahren zum Ausschluss von Hirnmetastasen sind nur bei symptomatischen Patienten, nicht aber bei asymptomatischen Patienten erforderlich)
    - Bekannter DPD-Mangel
    - Gleichzeitige Therapie mit dem Virostatikum Sorivudin oder dessen chemischen Verwandten Brivudin
    - Schwangere oder stillende Frauen; nicht-effektive Kontrazeption bei Männern und prämenopausalen Frauen (eine effektive Methode der Kontrazeption hat einen Pearl Index <1)
    - Teilnahme an einer anderen Studie innerhalb von 28 Tagen vor Studieneinschluss und während der Studie
    - Hypersensitivität gegenüber einer der in der Studie eingesetzten Substanzen oder sonstige Bestandteile
    - Frühere oder bestehende Keratitis oder ulcerativer Keratitis oder Bestehen einer schwerwiegende Augentrockenheit
    E.5 End points
    E.5.1Primary end point(s)
    1-year survival rate
    1-Jahresüberlebensrate
    E.5.1.1Timepoint(s) of evaluation of this end point
    weekly/biweekly during study treatment, every 3 month during follow up
    wöchentlich/alle 2 Wochen während der Studienbehandlung, alle 3 Monate während des Follow Up
    E.5.2Secondary end point(s)
    evaluation of therapeutic efficacy parameter (ORR, DCR, PFS, OS) in Rash-positive and –negative patients
    Evaluation von Parametern der therapeutischen Effektivität (ORR, DCR, PFS, OS) bei Rash-positiven und -negativen Patienten
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 8 weeks during study treatment, every 3 month during follow up
    alle 8 Wochen während der Studienbehandlung, alle 3 Monate während des Follow Up
    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 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) 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 No
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 150
    F.1.3Elderly (>=65 years) No
    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 No
    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 state150
    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 Decision2012-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-01
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