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    Summary
    EudraCT Number:2015-004134-95
    Sponsor's Protocol Code Number:M15PAS
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-004134-95
    A.3Full title of the trial
    Phase II clinical study of concurrent PAzopanib for non-metastatic SArcoma patients to be treated with RadioTherapy, localized in the extremities, trunk and chest wall or the head and neck region
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fase II onderzoek waarin de effectiviteit van 800 mg pazopanib in tabletvorm toegevoegd aan de standaard 25x bestraling wordt onderzocht, bij patiënten met weke delen tumoren in de armen of benen, de borstkas of buikwand en het hoofd/hals gebied (PASART-2)
    Phase II study to investigate the efficacy of adding 800 mg oral pazopanib to standard 25 x 2 Gy radiotherapy at patients with non-metastatic SArcoma patients lokalized in the extremities, trunk and chest wall or in the head and neck region
    A.3.2Name or abbreviated title of the trial where available
    PASART-2
    A.4.1Sponsor's protocol code numberM15PAS
    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 SponsorThe Netherlands Cancer Institute
    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 supportThe Netherlands Cancer Institute
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Netherlands Cancer Institute
    B.5.2Functional name of contact pointDirector
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3120512 9111
    B.5.6E-maile.voest@nki.nl
    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
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Film-coated 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
    non-metastatic sarcoma patients localized in the extremities, trunk and chest wall or the head and neck region
    E.1.1.1Medical condition in easily understood language
    sarcoma localized in extremities, trunk and chest wall or the head and neck region
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10039491
    E.1.2Term Sarcoma
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10039492
    E.1.2Term Sarcoma bone
    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
    To investigate the proportion of patients with resection specimens demonstrating induction of a pathological (near) complete remission (≥ 95% tumor regression)
    E.2.2Secondary objectives of the trial
    To study tumour changes to pre-operative pazopanib and radiotherapy measured by diffusion-weighted and/or blood oxygenation level-dependent MR imaging (DW-MRI or BOLD-MRI), to assess tolerability and toxicity profile of pazopanib with radiotherapy in the pre-operative setting, to determine response to pazopanib and radiotherapy by RECIST 1.1. criteria, to describe any pathological evidence of tumor regression after pre-operative pazopanib and radiotherapy, to determine local control rates, to investigate the rate of R0 and R1 resections, to investigate the incidence of post-operative wound complications, to investigate recurrence rate at 5 years (local and/or distant disease)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, for which the standard treatment is a combination of radiotherapy and surgery (deep seated, > 5cm according to the RECIST 1.1 criteria and/or an anticipated close resection margin, grade II/III according to the WHO definition)
    • Age ≥ 18 years
    • WHO performance status of ≤ 1
    • Able and willing to undergo blood sampling for PK and PD analysis
    • Able to swallow and retain oral medication
    • Able and willing to undergo MRI scanning
    • Able and willing to undergo tumor biopsies
    • Adequate organ functions as described by the laboratory findings in table 1. For thyroid function, the T4 and TSH values must be within normal values of the range of the participating centers
    • Written informed consent
    E.4Principal exclusion criteria
    • Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
    • Patients with recurrent sarcomas (even without prior radiotherapy)
    • Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas
    • Clinically significant gastrointestinal abnormalities which might interfere with oral dosing diagnosed
    • Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥ 140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]
    • Unstable or serious concurrent condition (e.g., active infection requiring systemic therapy)
    • Prolongation of corrected QT interval (QTc) > 480 msecs on ECG
    • History of any one of more cardiovascular conditions within the past 6 months
    • Macroscopic hematuria
    • Hemoptysis that is clinically relevant within 4 weeks of first pazopanib
    • Evidence of active bleeding or bleeding diathesis
    • Prior major surgery or trauma within 28 days prior to first dose of study medication
    • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth
    E.5 End points
    E.5.1Primary end point(s)
    The resection specimen of each patient will evaluated for the individual percentage of tumor regression. For the analysis of this primary endpoint, a patient is either a “success” (a pathological (near) complete remission being ≥ 95% tumor regression) or a “failure” (< 95% tumor regression). The proportion of patients with resection specimens demonstrating a pathological (near) complete remission will be calculated. The percentage tumor regression is the proportion of the tumor mass replaced with other tissue where the tumor has regressed, usually fibrous or fibro- inflammatory tissue, necrosis, calcifications or acellular mucin pools
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks post treatment at surgery
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 20
    F.4.2.2In the whole clinical trial 35
    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)
    normal standard care
    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 Decision2015-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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