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    Summary
    EudraCT Number:2017-003382-10
    Sponsor's Protocol Code Number:PazoQol
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-06
    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 number2017-003382-10
    A.3Full title of the trial
    Quality of life in patients with non-adipocyte soft tissue sarcoma under
    palliative chemotherapy or pazopanib – a randomized, controlled trial-
    PazoQoL
    Lebensqualität bei Patienten mit nicht-adipozytärem
    Weichgewebssarkom unter palliativer Chemotherapie oder Pazopanib -
    eine randomisierte, kontrollierte Studie -PazoQol
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Soft Tissue sarkomas (STS) are rare tumors, orginated from connective
    tissue and supporting connective tissue. For patients with progressed
    STS are different options for palliative treatment. In PazoQol the two
    options Chemotherapy and Pazopanib should be compared with focus on
    patient reported outcomes.
    Weichgewebesarkome sind seltene Tumore die von den Binde- und
    Stützgeweben des Körpers ausgehen. Für Patienten mit einem
    forgeschrittenem Weichteilsarkom gibt es mehrere
    Behandlungsoptionen. In dieser Studie werden die Behandlungsoption
    Chemotherapie und Pazopanib miteinander verglichen, wobei der Fokus
    auf der Lebenqualität der Patienten liegt.
    A.3.2Name or abbreviated title of the trial where available
    PazoQol
    PazoQol
    A.4.1Sponsor's protocol code numberPazoQol
    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 SponsorGWT-TUD GmbH
    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 supportNovartis
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGWT-TUD GmbH
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressFreiberger Strasse 33
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01067
    B.5.3.4CountryGermany
    B.5.4Telephone number+4903515933100
    B.5.5Fax number+4903515933111
    B.5.6E-mailcontact@gwtonline.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 namePazopanib
    D.3.4Pharmaceutical form 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
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200 to 400
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameGemcitabin
    D.3.4Pharmaceutical form Powder for dispersion 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameAnthracycline
    D.3.4Pharmaceutical form Powder for 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 INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number90
    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 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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameIfosphamid
    D.3.4Pharmaceutical form Powder for dispersion 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 INNIFOSFAMIDE
    D.3.9.1CAS number 3778-73-2
    D.3.9.4EV Substance CodeSUB08125MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2,4
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameDacarbazin
    D.3.4Pharmaceutical form Powder for dispersion 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 INNDACARBAZINE
    D.3.9.1CAS number 4342-03-4
    D.3.9.4EV Substance CodeSUB06882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number250
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameTrabectedin
    D.3.4Pharmaceutical form Powder for dispersion 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 INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1,5
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 nameDocetaxel
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/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.3.9.2Current sponsor codeDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number75
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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 namepaclitaxel
    D.3.4Pharmaceutical form Concentrate for dispersion 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number175
    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
    Soft tissue sarcoma (STS)
    Weichgewebesarkome
    E.1.1.1Medical condition in easily understood language
    tumore in connective tissue
    Tumore im Binde -und Stützgewebe
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10041298
    E.1.2Term Soft tissue sarcomas histology 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10075333
    E.1.2Term Soft tissue sarcoma
    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
    • Compare the overall quality of life (QoL) under treatment with
    pazopanib or physician-preferred chemotherapy after 9 weeks
    Allgemeine Lebensqualität (LQ) nach 9 Wochen, erhoben mit dem
    Summenwert des EORTC QLQ-C30 Fragebogens
    E.2.2Secondary objectives of the trial
    Patient-reported outcomes (PROs)
    Clinical outcomes
    Predictors of toxicity in patients 60 years and older
    Safety parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The informed consent form must be signed before any study specific
    tests or procedures are done
    • Male or female patients aged 18 years and older at the first screening
    visit
    • Histologically confirmed diagnosis of advanced or metastatic nonadipocyte
    STS
    • Suitable for treatment with pazopanib in an in-label prescription
    • Patients with a life expectancy of at least 6 months
    • ECOG performance status 0-2
    • Adequate organ function as given in Table 1
    • For patients with previous anthracycline therapy a normal heart
    function needs to be documented with an LVEF of minimal 50%
    (echocardiogram or MUGA scan)
    • Patients must be willing and able to fill in the QoL questionnaires
    using a tablet PC
    • Ability to understand and follow study-related instructions
    • Confirmation of the subject's health insurance coverage prior to the
    first visit
    Unterzeichnete Einwilligungserklärung
    • Männliche oder weibliche Patienten ab 18 Jahre (inklusive)
    • Histologisch bestätigte Diagnose einer fortgeschrittenen oder
    metastasierten, nicht-adipozytären Sarkomerkrankung des
    Weichgewebes
    • Geeignet für die In-Label-Behandlung mit Pazopanib
    • Arzteingeschätzte Lebenserwartung mindestens 6 Monate
    • ECOG performance Status 0-2
    • Adäquate Organfunktion
    • Für Patienten mit vorausgegangener Anthracyclin-Therapie muss
    eine normale Herzfunktion dokumentiert sein (linksventrikuläre
    Auswurffraktion mindestens 50%)
    • Bereitwilligkeit und Fähigkeit des Patienten, Fragebögen mit Hilfe
    eines Tablet-PCs zu beantworten
    • Fähigkeit, studienbezogenen Instruktionen zu folgen
    • Bestehende Krankenversicherung des Patienten
    E.4Principal exclusion criteria
    Subjects are to be excluded from the study if they display any of the
    following criteria:
    • Pretreatment with pazopanib
    • Contraindications according to the local SmPC of Votrient® (see
    Appendix 1)

    Patients having to following STS specific Tumors:
    o adipocyte sarcoma including all subtypes
    o all rhabdomyo sarcoma,
    o Chondro sarcoma
    o Osteo sarcoma
    o Ewing-tumors,
    o Dermatofibrosarcoma protuberans
    o Inflammatory myofibroblastic sarcoma
    o Malignant mesotheliom
    o Mixed mesenchymal and epidermal tumors of the uterus.


    • Other malignant underlying diseases with the exception of the
    following:
    o Free of disease for at least three years
    o Completely resected, non-melanoma skin cancer
    o Successfully treated carcinoma in situ
    o Patients with metastases of the central nervous system (CNS) at
    screening, which are asymptomatic AND do not require treatment with
    steroids or enzyme-inducing anticonvulsant drugs
    o Patients with metastases of the CNS, which are already treated
    (operation and/or radiotherapy, radiosurgery or gamma-knife)
    • Major surgery or trauma within 28 days before the first dose of
    study medication and / or presence of a non-healing wound, fracture,
    or ulcer (procedures like insertion of an ureteral stent are not regarded
    as major surgery)
    • Clinical indications of an active bleeding or a bleeding diathesis
    • Known endobronchial lesions or lesions that infiltrate the large
    pulmonary artery
    • Hemoptysis of > 2.5 mL within eight weeks before the first dose of
    study drug
    • Existing uncontrolled infection
    Heart rate-corrected QT-time according to the Fridericia´s-formula
    (QTcF) ≥ 450 ms in males and ≥ 460 ms in females
    • History of one or more of the following cardiovascular diseases
    within the last 6 months:
    o Cardiac angioplasty or coronary stent
    o Myocardial infarction
    o Unstable angina pectoris
    o Coronary artery bypass surgery
    o Symptomatic peripheral arterial disease
    • Cardiac insufficiency NYHA functional class III or IV
    Poorly controlled hypertension defined as systolic blood pressure ≥
    140 mmHg or diastolic blood pressure ≥ 90 mmHg. (Note: Start or
    adjustment of antihypertensive medication prior to study entry is
    allowed. Blood pressure should in this case be be stable for at least 2 weeks and re-evaluated at least
    twice with a minimum distance of 1 hour. The average of all
    measurements must be <140/90 to allow inclusion of the patient).
    • History of cerebrovascular disease, including transient ischemic
    attacks (TIA), pulmonary embolism or untreated deep vein thrombosis
    within 6 months prior to study entry. Patients with deep vein
    thrombosis who have received therapeutic anticoagulation for a
    minimum of six weeks might be included in the study.
    • Clinically significant gastrointestinal changes that increase the risk
    of gastrointestinal bleeding, including (but not exclusively):
    o Active peptic ulceration
    o Known intraluminal metastases with a risk of bleeding
    o Inflammatory bowel disease (e.g. Morbus Crohn, Colitis ulcerosa) or
    other gastrointestinal disease with increased risk of perforation
    o A history of existing abdominal fistula, gastrointestinal perforation
    or intra-abdominal abscess within 28 days prior to study entry
    • Clinically significant gastrointestinal changes that may affect the
    absorption of the study drugs, including (but not exclusively):
    malabsorption or resection of the stomach or small intestine
    • Treatment with any of the following anti-neoplastic therapies:
    o Irradiation or tumor embolization within 14 days prior to the first
    dose of study drug
    o Chemotherapy, immunotherapy, biological therapy, study
    medication or hormonal therapy within 14 days or five half-lives of
    substance (whichever is longer) prior to the first dose of study drug
    • If the discontinuation of prohibited medication (see Section 6.9) at
    least 14 days or five half-lives of substance (whichever is longer) prior
    to the first dose of pazopanib is medically not acceptable or refused by
    the patient
    • A history of hypersensitivity to any of the study drugs or their
    ingredients or to drugs with similar chemical structure
    • Addiction or other diseases that preclude the patient from
    appropriately assessing the nature and scope as well as possible
    consequences of the clinical trial
    • Pregnant or breast-feeding women
    • Women of childbearing potential unless women who meet the
    following criteria:
    o Post-menopausal (12 months natural amenorrhea or 6 months
    amenorrhea with serum FSH > 40 U / ml)
    o Postoperatively (six weeks after bilateral ovariectomy with or
    without hysterectomy)
    o Regular and correct use of a contraceptive method with error rate
    <1% per year such as implants, depot injections, oral contraceptives or
    intrauterine devices
    o Sexual abstinence
    o Vasectomy of the partner
    • Men of sexual activity with women of childbearing potential who are
    not willing to use an effective barrier method
    Vorausgegangene Behandlung mit Pazopanib
    • Kontraindikationen gemäß Fachinformation von Votrient®
    • Andere Krebserkrankungen mit folgenden Ausnahmen
    o Krankheitsfreiheit innerhalb der letzten drei Jahre
    o Vollständig entfernter, nicht bösartiger Hautkrebs
    o Erfolgreich behandeltes Karzinom in situ
    o Patienten mit Metastasen im Zentralnervensystem (ZNS) zum
    Zeitpunkt des Screenings, die asymptomatisch sind UND keiner
    Behandlung mit Steroiden oder enzyminduzierenden Antikonvulsiva
    bedürfen
    o Patienten mit Metastasen im ZNS, die bereits behandelt wurden
    (Operation, Radiotherapie etc.)
    • Schwere Operation oder Trauma innerhalb der letzten 28 Tage
    und/oder Vorhandensein einer nichtheilenden Wunde, Fraktur oder
    eines Geschwürs
    • Klinische Zeichen einer aktiven Blutung oder Blutungsbereitschaft
    • Bekannte endobronchiale Läsionen oder Infiltrate der großen
    Pulmonalarterie
    • Hämoptyse von > 2.5 ml innerhalb der letzten 8 Wochen
    • Vorliegende unkontrollierte Infektion
    • QTcF ≥ 450 ms bei Männern oder ≥ 460 ms bei Frauen
    • Historie von mindestens einer der folgenden kardiovaskulären
    Krankheiten innerhalb der letzten 6 Monate:
    o kardiale Angioplastie oder koronarer Stent
    o Herzinfarkt
    o Instabile Angina pectoris
    o Bypass der Koronararterie
    o Symptomatische periphere Arterienerkrankung
    Herzinsuffizienz NYHA Klasse III oder IV
    • Schlecht kontrollierter Bluthochdruck (systolischer Blutdruck ≥ 140
    mmHg oder diastolischer Blutdruck ≥ 90 mmHg)
    • Historie einer zerebrovaskulären Erkrankung einschließlich
    vorübergehende Durchblutungsstörung, Lungenembolie oder
    unbehandelte tiefe Venenthrombose in den letzten 6 Monaten.
    Patienten, die zur Behandlung der tiefen Venenthrombose für
    mindestens 6 Wochen Antikoagulantien erhalten haben, dürfen
    eingeschlossen werden
    • Klinisch relevante gastrointestinale Veränderungen mit
    gesteigertem Risiko einer gastrointestinalen Blutung
    • Klinisch relevante gastrointestinale Veränderungen, die die
    Resorption der Studienmedikamente beeinflussen könnten
    • Behandlung mit einer der folgenden anti-neoplastischen Therapien:
    o Bestrahlung oder Tumorembolisation innerhalb der letzten 14 Tage
    o Chemotherapie, Immuntherapie, biologische Therapie,
    Studienmedikation oder hormonelle Therapie innerhalb der letzten 14
    Tage oder 5 Halbwertszeiten der Substanz vor erster Gabe der
    Studienmedikation
    • Abbruch der Behandlung mit nicht zulässigen Begleitmedikationen
    mindestens 14 Tage oder 5 Halbwertszeiten der Substanz vor der
    ersten Gabe der Studienmedikation ist medizinisch nicht vertretbar
    oder wird vom Patienten zurückgewiesen
    Hypersensibilität gegenüber Medikamenten oder deren
    Inhaltsstoffen oder gegenüber Substanzen mit chemisch ähnlicher
    Struktur
    • Sucht oder eine andere Erkrankung, die ausschließt, dass der
    Patient den Zweck und die Risiken der klinischen Studie einschätzen
    kann
    • Schwangere oder stillende Frauen
    • Gebärfähige Frauen sofern nicht die folgenden Voraussetzungen
    erfüllt sind:
    o Postmenopausal (12 Monate natürliche Amenorrhö oder 6 Monate
    Amenorrhö mit FSH im Serum > 40 U / ml)
    o Postoperativ (6 Wochen nach bilateraler Ovariektomie mit oder
    ohne Hysterektomie)
    o Regelmäßige und korrekte Verwendung einer kontrazeptiven
    Methode mit einer Fehlerrate von < 1% pro Jahr wie z.B. Implantate,
    Depotinjektionen, orale Kontrazeptiva oder Intrauterinpessar
    o Sexuelle Abstinenz
    o Vasektomie des Partners
    • Männer, die mit gebärfähigen Frauen sexuell aktiv sind und nicht
    bereit sind eine wirksame Barrieremethode zu verwenden während und
    bis zu 3 Monate nach Ende der Studienmedikation
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable assessed in this study is the overall QoL
    measured by EORTC QLQ-C30 (sum score) after 9 weeks of treatment.
    Vergleich der Lebensqualität nach 9 Wochen Behandlung mit
    Pazopanib oder vom behandelnden Arzt gewählter Chemotherapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 9 weeks of treatment.
    nach 9 Wochen
    E.5.2Secondary end point(s)
    Patient-reported outcomes (PROs)
    • Overall QoL and functional dimensions as well as symptoms,
    measured by EORTC QLQ-C30 in Week 1, 2, 3 compared to Week 7, 8, 9
    • Pain measured by BPI-SF (baseline and Week 3, 6, 9)
    • Fatigue measured by MFI (baseline and Week 3, 6, 9)
    • Satisfaction with the tumor treatment measured by CTSQ (baseline
    and Week 9)
    • Anorexia/cachexia syndrome (ACS) measured by FAACT (baseline
    and Week 9)
    • Therapy-associated impairment and burden measured by the
    adapted MDASI (baseline and Week 3, 6, 9)
    • Individual subjective benefit assessment of the therapy by the
    patient using the time trade-off method (baseline and Week 9)
    Clinical outcomes
    • Progression free survival (PFS)
    • Overall survival (OS)
    • Objective response rate (ORR)
    • Clinical benefit rate (CBR)
    • Parameter determined by RECIST 1.1
    Predictors of toxicity in patients 60 years and older
    • Predictors of toxicity according to Hurria et al.
    • Vulnerable Elderly Scale (VES-13)
    • Charlson Comorbidity Index
    Safety parameters
    Safety laboratory analyses (for details see Table 5), dose reductions
    and delay, AEs, concomitant medication
    Vergleich:
    -der Lebensqualität unter Behandlung mit Pazopanib oder vom
    behandelnden Arzt gewählter Chemotherapie dreimal je in Zyklus 1
    und 3 (Woche 1, 2, 3 und 7, 8, 9)
    -der beiden Behandlungsgruppen in Bezug auf Schmerzen als ein
    Hauptsymptom für Weichgewebssarkom
    -der beiden Behandlungsgruppen in Bezug auf Erschöpfung und deren
    verschiedene Kategorien (physisch, mental, kognitiv, emotional)
    - der beiden Behandlungsgruppen in Bezug auf Anorexie/Kachexie als
    Marker für gesundheitsbezogene Lebensqualität
    - der beiden Behandlungsgruppen in Bezug auf die Zufriedenheit mit
    der Tumorbehandlung
    und Untersuchung des Zusammenhangs der Lebensqualität mit
    Kriterien des Ansprechens auf die Therapie (RECIST 1.1, if feasible)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient-reported outcomes (PROs)
    -Overall QoL and functional dimensions as well as symptoms,
    measured by week 7, 8, 9
    --BPI-SF (baseline and Week 3, 6, 9)
    -F- MFI (baseline and Week 3, 6, 9)
    - CTSQ (baseline and Week 9)
    -FAACT (baseline and Week 9)
    -Therapy-associated impairment and burden measured by the adapted
    MDASI (baseline and Week 3, 6, 9)
    -Individual subjective benefit assessment of the therapy by the patient
    using the time trade-off method (baseline and Week 9)
    Clinical outcomes (week 1,3,6,9)
    Safety parameters and dose reductions and delay, AEs, concomitant
    medication(week 1,3,6,9 (and during 2 years follow up everny 12
    weeks)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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
    chemotherapy
    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 concerned12
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    End of the trail is the study report in Q1/2023
    Das Studienende ist durch den Studienreport definiert (Q1/2023)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 150
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GISG (German interdisciplinary sarkoma group)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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