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    Summary
    EudraCT Number:2015-004134-95
    Sponsor's Protocol Code Number:M15PAS/DSSG02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-10
    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 ConcernedUK - MHRA
    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
    PASART 2
    A.3.2Name or abbreviated title of the trial where available
    PASART 2
    A.4.1Sponsor's protocol code numberM15PAS/DSSG02
    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 Royal Marsden NHS Fundation Trust
    B.5.2Functional name of contact pointGalina Petrikova
    B.5.3 Address:
    B.5.3.1Street AddressFulham Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW3 6JJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02078118090
    B.5.5Fax number02073490701
    B.5.6E-mailgalina.petrikova@rmh.nhs.uk
    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.2.5The 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
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    soft tissue sarcoma
    E.1.1.1Medical condition in easily understood language
    sarcoma/cancer
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10024627
    E.1.2Term Liposarcoma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10016632
    E.1.2Term Fibrosarcoma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10049067
    E.1.2Term Spindle cell 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10024189
    E.1.2Term Leiomyosarcoma
    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 investigate the proportion of patients following pre-operative radiotherapy with pazopanib with resection specimens demonstrating induction of a pathological (near) complete remission (≥ 95% tumor regression)
    E.2.2Secondary objectives of the trial
    Secondary Objectives
     To assess tolerability and toxicity profile in the pre‐operative setting.
     To assess acute toxicities and late toxicities of combination of radiotherapy and pazopanib
     To determine tumour response using the RECIST 1.1 criteria
     To describe any pathological evidence of tumour regression after pre‐operative pazopanib and radiotherapy
     To determine local control rates
     To determine the rate of R0 resection
     To determine the rate of R1 resection
     Incidence of post‐operative wound complications
     Recurrence rate at 5 years (local and/or distant disease).

    Exploratory Objectives
     Correlation between diffusion weighted MRI characteristics and histopathological response evaluation
     To study tumour changes measured by dynamic contrast enhanced MRI (DCE‐MRI), diffusionweighted MRI (DW‐MRI) and blood‐oxygenation‐level‐dependent (BOLD) MR imaging
     Correlation between pazopanib PK plasma and pazopanib PK tumour tissue
     PK/PD correlations:
     Correlat
    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 and 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 FNLCC 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 the 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 prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
    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 as:
    Active peptic ulcer disease
    Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
    History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
    Major resection of the stomach or small bowel
    •Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]
    Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be <140/90 mmHg (or 150/90 mm Hg, if this criterion is approved by the Principal Investigator) in order for a subject to be eligible for the study.
    •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 of more of the following cardiovascular conditions within the past 6 months:
    Cardiac angioplasty or stenting
    Myocardial infarction
    Unstable angina
    Symptomatic peripheral vascular disease
    Coronary artery by-pass graft surgery
    Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
    History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
    •Macroscopic hematuria
    •Hemoptysis that is clinically relevant within 4 weeks of first dose of pazopanib
    •Evidence of active bleeding or bleeding diathesis
    •Prior major surgery or trauma within 28 days prior to first dose of study medication and/or presence of any non-healing wound, fracture, or ulcer
    •Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study medication
    •Biological therapy or treatment with an investigational agent within 28 days or five half-lives, whichever is longer prior to the first dose of study medication
    •Prohibited medications listed in the protocol for 14 days or five half-lives of a drug (whichever is longer) prior to visit 1 and for the duration of the study
    •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
    •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    •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
    Following 6 weeks of Pazopanib with radiotherapy for 5 weeks of this schedule, participants will have an imaging assessment for resoinse at 4 weeks after completing radiotherapy and pazopanib with surgery at 6-8 weeks after completing radiotherapy and pazopanib. This will provide the tumor resection speciment from which to evaluate histological response
    E.5.2Secondary end point(s)
    • Proportion of patients completed radiotherapy without delay (By definition for this protocol, any lengthening of the overall treatment time by ≤ 3 days is not a delay. Any increase in the overall treatment time of ≥ 4 days will be registered as a delay, including the reason for delay (e.g. machine down-time, public holidays, toxicity etc.)
    • Incidence of acute and late toxicities measured by NCI-CTCAE v4.0 and EORTC/RTOG scoring systems respectively (radiotherapy alone, pazopanib alone or both).
    • Rate of response as measured by RECIST v 1.1 at 4 weeks after completing radiotherapy
    • Incidence of acute post-operative wound complications up to 3 weeks (+/- 1 week) after surgery as defined in section 6.1.3 and reference 29
    • Local control rate at 2 years , defined as the absence of sarcoma at the original site, counted from day of surgery
    • Rate of R0 resections
    • Rate of R1 resections
    • Disease free survival at 2 and 5 years
    • Overall survival at 2 and 5 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    as listed above
    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 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 concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Netherlands
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 months0
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    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)
    not applicable as drug given with pre-operative radiotherapy alone.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-03
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