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    Summary
    EudraCT Number:2009-014895-23
    Sponsor's Protocol Code Number:#0038
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-014895-23
    A.3Full title of the trial
    Phase II clinical trial of a sequential therapy involving the FLOT regiment in palliative first-line treatment followed by AIO plus irinotecan in second-line treatment combined with supportive parenteral nutrition and physical activity in patients with advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction - impact on quality of life and fatigue: FLOTIRI - gastric cancer trial
    Phase II-Studie einer Therapiesequenz mit dem FLOT-Regime in der palliativen Erstbehandlung gefolgt von AIO plus Irinotecan in der Zweitbehandlung zusammen mit supportiv-parenteraler Ernährung und Bewegungstherapie bei Patienten mit fortgeschrittenem inoperablem Adenokarzinom des Magens und des gastroösophagealen Überganges –
    Einfluss auf Lebensqualität und Fatigue:
    FLOTIRI – Magenkarzinom-Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II clinical trial of palliativ treatment of patients with advanced non-operable gastric carcinoma: FLOT regimen followed by AIO regimen and irinotecan combined with artificial nutrition and physical activity - impact on quality of life and fatigue: FLOTIRI gastric cancer trial
    Klinische Prüfung der Phase II der palliativen Therapie von Patienten mit fortgeschrittenem inoperablem Magenkarzinom: FLOT-Regime gefolgt von AIO-Regime mit Irinotecan zusammen mit künstlicher Ernährung und Bewegungstherapie - Einfluss auf Lebensqualität und Müdigkeit: FLOTIRI Magenkarzinom-Studie
    A.3.2Name or abbreviated title of the trial where available
    FLOTIRI
    FLOTIRI
    A.4.1Sponsor's protocol code number#0038
    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 SponsorUniversitätsklinikum Erlangen
    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 supportmedac Gesellschaft für klinische Spezialpräparate mbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportStiftung Leben mit Krebs
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointMedizinische Klinik 1
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number004991318535060
    B.5.5Fax number004991318535062
    B.5.6E-mailaxel.wein@uk-erlangen.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.3.4Pharmaceutical 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 INN5-FLOUROURACIL
    D.3.9.3Other descriptive name5-FLOUROURACIL
    D.3.9.4EV Substance CodeSUB27520
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.1.2Country 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.3.4Pharmaceutical form Solution for injection
    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 INNFOLIC ACID
    D.3.9.1CAS number 59-30-3
    D.3.9.4EV Substance CodeSUB07774MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    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 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.3.4Pharmaceutical 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 INNDOCETAXEL
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    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 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
    Advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction
    Fortgeschrittenes inoperables Adenokarzinom des Magens und des gastroösophagealen Übergangs
    E.1.1.1Medical condition in easily understood language
    Advanced non-operable stomach cancer
    Fortgeschrittener inoperabler Magenkrebs
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Median survival
    Mediane Überlebenszeit
    E.2.2Secondary objectives of the trial
    • Response rate to first and second line treatment („best response“; CR, PR)
    • Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria
    • One- and 2-year survival rate
    • Percentage of patients with stable disease (SD)
    • Time to progression (TTP) of first and second-line treatment
    • NCI-CTC toxicity of first and second-line treatment
    • Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment
    • Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment
    • Percentage of secondary curative resection of metastases (after downsizing by palliative first-line treatment
    • Bestimmung der Ansprechrate der Erst- und Zweitbe-handlung („best response“; CR, PR)
    • Histologischer Remissionsgrad im Resektionspräparat (Primärtumor und Fernmetastasen) nach Becker-Kriterien
    • Ein- und Zweijahresüberlebensrate
    • Anteil der Patienten mit Stabilisierung der Erkrankung (SD)
    • Zeit bis zur Tumorprogression (TTP) der Erst- und der Zweitbehandlung
    • Erfassung der Toxizität (NCI-CTC) der Erst- und Zweitbehandlung
    • Erfassung der Lebensqualität (EORTC-QLQ-C15-PAL) und Fatigue (MFI) während der palliativen Erst- und Zweitbehandlung
    • Einfluss der supportiven parenteralen Ernährung und der Bewegungstherapie auf Lebensqualität und Fatigue während der palliativen Erst- und Zweitbehandlung
    • Rate der sekundären kurativen Metastasenresektion (nach Downsizing durch die palliative Erstbehandlung
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically proven advanced adenocarcinoma of the stomach or the gastro-oesophageal junction with distant metastases including lymph node metastasis, e.g. supraclavicular or para-aortal (M1 [HEP, PUL, LYM] (UICC stage IV)
    • Age: ≥ 18 und ≤ 75 years
    • Life expectancy: minimum 3 months
    • ECOG index 0-2
    • Sufficient bone marrow function defined as leucozytes  3.500/µl, thrombocytes  100.000/µl
    • Sufficient renal function defined as serum creatinine  2,0 mg/dl or creatinin clearance > 30 ml/min.
    • Sufficient hepatic function defined as serum bilirubine  2,0 mg/dl, exception: orbus Gilbert-Meulengracht
    • Signed informed consent
    • Histologisch nachgewiesenes fortgeschrittenes Adenokarzinom des Magens und des gastroösophagealen Überganges mit Fernmetastasen, auch Lymphknotenmetastasen, z.B. supraclaviculär oder para-aortal (M1 [HEP, PUL, LYM] (UICC-Stadium IV)
    • Alter: ≥ 18 und ≤ 75 Jahren
    • Lebenserwartung: mindestens drei Monate
    • ECOG – Index 0-2
    • Ausreichende Knochenmarksreserve definiert als Leukozyten  3.500/µl, Thrombozyten  100.000/µl
    • Ausreichende Nierenfunktion definiert als Serumkreatinin  2,0 mg/dl oder Kreatininclearance > 30 ml/min.
    • Ausreichende Leberfunktion definiert als Serumbilirubin  2,0 mg/dl, Ausnahme: Morbus Gilbert-Meulengracht
    • Schriftliches Einverständnis des Patienten nach Aufklärung
    E.4Principal exclusion criteria
    • Hypersensibility to 5-FU, sodium folinate, irinotecan, docetaxel oder oxaliplatin
    • Previous systemic chemotherapy
    • Severe concomitant diseases which preclude therapy
    • Bone marrow suppression
    • Chronic diarrhoea (> NCI – CTC - grade 1)
    • Chronic inflammatory intestinal diseases or subtotal intestinal obstruction
    • Concomitant therapy with other anticancer drugs
    • Treatment with allopurinol and trimethroprim
    • Pregnancy and lactation
    • No adequate contrazeption for pre-menopausal females
    • Participation in clinical trials with non-approved drugs
    • Überempfindlichkeit gegenüber 5-FU, Natriumfolinat, Irinotecan, Docetaxel oder Oxaliplatin
    • Vorherige systemische Chemotherapie
    • Schwerwiegende internistische Begleiterkrankungen, die eine Therapie ausschließen
    • Knochenmarksinsuffizienz
    • Chronische Diarrhoe (> NCI – CTC - Grad 1)
    • Chronisch entzündliche Darmerkrankungen oder subtotale Darmobstruktion
    • Begleittherapie mit anderen antineoplastischen Substanzen
    • Therapie mit Allopurinol und Trimethroprim
    • Gravidität und Laktation
    • Keine adäquate Kontrazeption für prämenopausale Frauen
    • Teilnahme an Studien mit nicht zugelassenen Medikamenten
    E.5 End points
    E.5.1Primary end point(s)
    Median survival
    Mediane Überlebenszeit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last visit last subject
    Letzte Visite des letzten Studienteilnehmers
    E.5.2Secondary end point(s)
    Response rate to first and second line treatment („best response“; CR, PR)
    • Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria
    • One- and 2-year survival rate
    • Percentage of patients with stable disease (SD)
    • Time to progression (TTP) of first and second-line treatment
    • NCI-CTC toxicity of first and second-line treatment
    • Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment
    • Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment
    • Percentage of secondary curative resection of metastases (after downsizing by palliative first-line treatment
    Bestimmung der Ansprechrate der Erst- und Zweitbe-handlung („best response“; CR, PR)
    • Histologischer Remissionsgrad im Resektionspräparat (Primärtumor und Fernmetastasen) nach Becker-Kriterien
    • Ein- und Zweijahresüberlebensrate
    • Anteil der Patienten mit Stabilisierung der Erkrankung (SD)
    • Zeit bis zur Tumorprogression (TTP) der Erst- und der Zweitbehandlung
    • Erfassung der Toxizität (NCI-CTC) der Erst- und Zweitbehandlung
    • Erfassung der Lebensqualität (EORTC-QLQ-C15-PAL) und Fatigue (MFI) während der palliativen Erst- und Zweitbehandlung
    • Einfluss der supportiven parenteralen Ernährung und der Bewegungstherapie auf Lebensqualität und Fatigue während der palliativen Erst- und Zweitbehandlung
    • Rate der sekundären kurativen Metastasenresektion (nach Downsizing durch die palliative Erstbehandlung
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last visit last subject
    Letzte Visite des letzten Studienteilnehmers
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    Letzte Visite des letzten Studienteilnehmers
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with incurable disease
    Patienten mit unheilbarer Erkrankung
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    None
    Keine
    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 Decision2013-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-30
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