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    Summary
    EudraCT Number:2012-005846-39
    Sponsor's Protocol Code Number:GISG-06
    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:2014-03-31
    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 number2012-005846-39
    A.3Full title of the trial
    Phase II, multicenter, open-label, single-arm trial in advanced and relapsed Angiosarcomas, to evaluate the efficacy of pazopanib (Votrient) in combination with standard of care treatment paclitaxel ( Evaluation of Votrient in angiosarcoma - EVA)
    Einarmige, multizentrische, offene Phase-II Studie zur Überprüfung der Wirksamkeit der Kombination von Pazopanib (Votrient) mit der Standardtherapie Paclitaxel bei fortgeschittenen und rezidivierten Angiosarkomen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy of Angiosarcomas with standard therapy paclitaxel in combination with pazopanib (Votrient)
    Beurteilung der Standardtherapie Paclitaxel in Kombination mit Pazopanib (Votrient)
    A.3.2Name or abbreviated title of the trial where available
    EVA (Evaluation of Votrient in angiosarcoma)
    A.4.1Sponsor's protocol code numberGISG-06
    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 SponsorUniversity of Heidelberg
    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 supportGlaxoSmithKline GmbH & Co. KG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversity of Heidelberg, Medical Faculty Mannheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Heidelberg, Medical Faculty
    B.5.2Functional name of contact pointGISG Regulatory Department
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Kutzer-Ufer 1-3
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68135
    B.5.3.4CountryGermany
    B.5.4Telephone number496213833433
    B.5.5Fax number496213831479
    B.5.6E-mailstudien@gisg.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 Votrient 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group 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 nameVotrient
    D.3.2Product code EMEA/H/C/001141
    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 INNPAZOPANIB HYDROCHLORIDE
    D.3.9.1CAS number 635702-64-6
    D.3.9.4EV Substance CodeSUB31270
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Votrient 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group 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 nameVotrient
    D.3.2Product code EMEA/H/C/001141
    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 INNPAZOPANIB HYDROCHLORIDE
    D.3.9.1CAS number 635702-64-6
    D.3.9.4EV Substance CodeSUB31270
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 and relapsed angiosarcoma
    fortgeschrittene und rezidivierende Angiosarkome
    E.1.1.1Medical condition in easily understood language
    Malignant soft tissue tumour
    Bösartiger Weichteiltumor
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10002481
    E.1.2Term Angiosarcoma stage unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10072814
    E.1.2Term Breast angiosarcoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10072813
    E.1.2Term Breast angiosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10025223
    E.1.2Term Lymphangiosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10025224
    E.1.2Term Lymphangiosarcomas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10002480
    E.1.2Term Angiosarcoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10057700
    E.1.2Term Angiosarcoma non-metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10018827
    E.1.2Term Haemangiosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10072891
    E.1.2Term Skin angiosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10067388
    E.1.2Term Hepatic angiosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10002477
    E.1.2Term Angiosarcoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10002476
    E.1.2Term Angiosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate progression free survival at 6 month (PFS-R)
    Rate des progessionsfreien Überlebens nach 6 Monaten (PFS-R)
    E.2.2Secondary objectives of the trial
    to evaluate response rate according to RECIST 1.1, overall survival and assessment of safety aspects
    das Gesamtüberleben, die Ansprechrate gemäß RECIST 1.1 und der Schweregrad der Nebenwirkungen bzw. Toxizität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
    Note: Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging studies) and obtained prior to signing informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
    2. Age ≥ 18 years
    3. Life expectancy > 3 months
    4. Ability to swallow tablets
    5. Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g. radiation-induced or angiosarcoma in chronical lymphedema) are eligible.
    6. Tumor must be locally advanced (unresectable) or metastatic. A progression must be documented within a 6-month period prior to screening.
    7. ECOG performance status ≤ 2
    8. At least one measurable skin lesion or one measurable radiological (CT or MRI) target lesion (RECIST 1.1)
    9. Adequate organ system function as described in protocoll
    10. A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use adequate contraception (as defined in protocol) during the study and for 30 days after the last dose of study drug.
    11. All sexually active male patients must agree to use adequate methods of birth control (see protocol) throughout the study and for 30 days after the last dose of study drug.
    1. Vorhandensein einer schriftlichen Einwilligung des Patienten
    2. Alter ≥ 18 Jahre
    3. Lebenserwartung > 3 Monate
    4. Fähigkeit Tabletten zu schlucken
    5. Histologisch gesichertes Angiosarkom.
    6. Lokal fortgeschrittene oder metastasierte Erkrankung mit einem Progress innerhalb der letzten 6 Monate vor Studieneinschluss
    7. ECOG ≤ 2
    8. Vorhandensein mindestens einer messbaren Hautmanifestation oder einer mit CT oder MRT messbaren Läsion (RECIST v1.1)
    9. Adäquate Organfunktion:
    Absolute Neutophilenzahl (ANC) ≥1.5 X 109/L
    Hämoglobin ≥9 g/dL (5.6 mmol/L)
    Thrombozyten ≥100 X 109/L
    Prothrombin-Zeit (PT) oder INR ≤1.2 X obere Normalgrenze (ULN)
    partielle Thromboplastinzeit (PTT) ≤ 1.2 X ULN
    Gesamt-Bilirubin ≤ 1.5 X ULN
    ASAT und ALAT ≤ 2.5 X ULN
    Serumkreatinin ≤ 1.5 mg/dL (133 μmol/L)
    wenn Serumkreatinin >1.5 mg/dL, dann kalkulierte glomeruläre Filtrationsrate (GFR) ≥ 50 mL/min
    Protein/Kreatinin Verhältnis (UPC) < 1, wenn UPC ≥1, dann 24h-Urinprotein < 1
    10. Gebärunfähigkeit oder negativer Schwangerschaftstest und adäquate Kontrazeption bei gebärfähigen Frauen
    11. Vorhandensein einer adäquaten Kontrazeption bei zeugungsfähigen Männern
    E.4Principal exclusion criteria
    1. Patients who need an active treatment for another malignant disease other than angiosarcoma
    2. Prior treatment with a taxan within the last 12 months before study entry
    3. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal sarcomatosis
    4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
    5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
    6. Presence of uncontrolled infection
    7. QT prolongation interval (QTc) > 480 msecs
    8. Clinically significant cardiovascular discorders within the past 6 months
    9. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
    10. Poorly controlled hypertension (see protocol)
    11. Evidence of active bleeding or bleeding diathesis
    12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
    13. Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put patient safety at risk, prevent giving informed consent or impact the patient's compliance with the use of study medication
    14. Women who are pregnant or breast feeding
    15. Patients who are not able or not willing to interrupt the intake of medications that are not allowed according to study protocol for at least 14 days before start of study medication and for the whole study period
    16. Chemotherapy or radiotherapy within 14 days before start of study medication
    17. Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
    1. Aktive Therapie für eine andere maligne Erkrankung als das Angiosarkom
    2. Behandlung mit einem Taxan innerhalb der letzten 12 Monate vor Studieneinschluss
    3. Vorhandensein von ZNS Metastasen oder leptomeningealen Sarkomatosen.
    4. Klinisch signifikante gastrointestinale Störungen mit/ erhöhtem Risiko für gastrointestinale-Blutungen.
    5. Klinisch signifikante gastrointestinale Störungen mit/ möglicher veränderter Absorption des Prüfpräparates.
    6. Vorhandensein unkontrollierter Infektionen.
    7.QT-Verlängerung im EKG, QTc > 480ms
    8. Klinisch signifikante Herz-Kreislauf-Erkrankungen innerhalb der letzten 6 Monate vor Studieneinschluss,
    9. „Großer“ operativer Eingriff innerhalb der letzten 28 Tage, nicht heilende Wunde oder Fraktur
    10. Schlecht eingestellter arterieller Hypertonus.
    11. Vorhandensein von massiver Blutung oder Blutungsneigung
    12. Vorhandensein von endobronchialen Läsionen und/oder Läsionen in den Lungengefäßen
    13. Nicht kontrollierte zerebrale Krampfanfälle, ZNS- oder psychiatrische Erkrankung, welche die Sicherheit des Patienten gefährdet, oder die Compliance beeinträchtigt.
    14. Schwangere Frauen und stillende Mütter
    15. Unfähigkeit oder fehlende Bereitschaft die Einnahme von den laut Prüfplan verbotenen Medikamenten für mindestens 14 Tage vor Gabe der ersten Studienmedikation und für die Dauer der Studie zu unterbrechen.
    16. Chemotherapie oder Strahlentherapie 14 Tage vor der ersten Gabe der Studienmedikation
    17. Anhaltende Toxizität von vorausgegangenen Anti-Krebs-Therapien die > Grad 1 und/oder fortschreitend im Schweregrad ist, außer Alopezie.
    E.5 End points
    E.5.1Primary end point(s)
    rate of progression free survival at 6 month (PFS-R)
    progressionsfreies Überleben nach 6 Monaten
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 Monate
    E.5.2Secondary end point(s)
    Overall survival (OS)
    Response Rate (RR rate according to RECIST Version 1.1)
    Toxicity (according to CTCAE, Version 4.0)
    Gesamt Überleben (OS)
    Ansprechrate (RR gemäß RECIST Version 1.1)
    Toxizitäten (gemäß CTCAE, Version 4.0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during study is running
    während der laufenden klinischen Prüfung
    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 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 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 EEA10
    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 Visit of the last subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation German Interdisciplinary Sarcoma Group (GISG)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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