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    Summary
    EudraCT Number:2013-003533-16
    Sponsor's Protocol Code Number:UMCN-ONCO-201303
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003533-16
    A.3Full title of the trial
    Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STS
    Is het vroeg meten van de tumorstofwisseling of bloedspiegels een mogelijke voorspeller voor het resultaat van de behandeling met pazopanib in patiënten met een weke delen tumor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STS
    Is het vroeg meten van de tumorstofwisseling of bloedspiegels een mogelijke voorspeller voor het resultaat van de behandeling met pazopanib in patiënten met een weke delen tumor
    A.3.2Name or abbreviated title of the trial where available
    PREDICT
    A.4.1Sponsor's protocol code numberUMCN-ONCO-201303
    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 SponsorRadboud University Nijmegen Medical Centre
    B.1.3.4CountryNetherlands
    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
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen Medical Centre
    B.5.2Functional name of contact pointResearch verpleegkundigen oncologie
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6524 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243610353
    D. IMP Identification
    D.IMP: 1
    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.2.1.1.1Trade name Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.2Product code L01XE11
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 patients
    E.1.1.1Medical condition in easily understood language
    soft tissue sarcoma patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 whether early metabolic response is correlated to clinical benefit. And to evaluate the effect of age on pazopanib pharmacokinetcs.
    E.2.2Secondary objectives of the trial
    To evaluate whether early metabolic response is correlated with pazopanib exposure. And to evaluate whether early metabolic response is correlated with the histological subtypes.
    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.
    2) Age ≥ 18 years or legal age of consent if greater than 18 years. Patients aged 66-69 are eligible for the imaging arm of the study, however they are excluded from the assessment of altered PK behavior in elderly.
    3) Histological confirmed diagnosis of selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy
    4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
    5) Measurable disease criteria (RECIST 1.1).
    6) No radio-, chemo- or tumor specific targeted therapy within the last 4 weeks prior to study entry.
    7) Adequate organ system function.
    8) Minimal evaluable laesion of ≥ 15mm.
    E.4Principal exclusion criteria
    1) Prior malignancy.
    2) Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 months time interval
    3) Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
    4) Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
    5) Corrected QT interval (QTc) > 480msecs
    6) History of one or more cardiovascular conditions within the past 6 months as unstable angina, myocardial infarction, etc.
    7) Poorly controlled hypertension
    8) History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) 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 (procedures such as catheter placement not considered to be major surgery).
    10) Evidence of active bleeding or bleeding diathesis
    E.5 End points
    E.5.1Primary end point(s)
    The aim of the study is to show distinction between the PFS curves between the patients who have a more or less pronounced metabolic response. The second primary end point is to show a difference in pazopanib exposure between elderly compared to younger patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On day 14 and 56 after start with pazopanib, pharmacokinetcs and metabolic response will be performed.
    E.5.2Secondary end point(s)
    To explore, quantify and describe the correlation between early metabolic response and pazopanib exposure on steady state pharmacokinetcs. To explore, quantify and describe the correlation between tumor histology and early metabolic response. To explore, quantify and describe the correlation between pazopanib exposure and the frequency of adverse events as graded by CTCAE v4.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On day 14 and 56 after start with pazopanib, pharmacokinetcs and metabolic response will be performed.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Treatment continues according to standard medical practise.
    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 Decision2013-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
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