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    Summary
    EudraCT Number:2013-005456-15
    Sponsor's Protocol Code Number:GEIS-32
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-07-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-005456-15
    A.3Full title of the trial
    A Phase II Open-Label Trial of Pazopanib Administered as a Single Agent in Patients with Unresectable or Metastatic Solitary Fibrous Tumor (SFT) and Extraskeletal Myxoid Chondrosarcoma (EMC)
    Essai de phase II, en ouvert, de pazopanib en monothérapie chez des patients porteurs de tumeurs fibreuses solitaires (SFT) et chondrosarcomes myxoïdes extra squelettiques (EMC), non résécables ou métastatiques.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy of pazopanib drug given to patients with solitary fibrous tumor (SFT) and extraskeletal myxoid chondrosarcoma (EMC) that cannot be removed with surgery or having metastasis
    Etude de l'efficacité du pazopanib chez des patients porteurs de tumeurs fibreuses solitaires ou de chondrosarcomes myxoïdes extra squelettiques ne pouvant être opérés ou étant disseminés.
    A.3.2Name or abbreviated title of the trial where available
    GEIS-32
    GEIS-32
    A.4.1Sponsor's protocol code numberGEIS-32
    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 SponsorGrupo Español de Investigación en Sarcomas
    B.1.3.4CountrySpain
    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 supportGrupo Español de Investigación en Sarcomas
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSofpromed Investigación Clínica, SLU
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Valldemossa, Km. 7,4
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07121
    B.5.3.4CountrySpain
    B.5.4Telephone number34648414261
    B.5.5Fax number34971570222
    B.5.6E-mailinfo@sofpromed.com
    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 holderGlaxo Group Limited
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.8 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 typerange
    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.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
    Patients with unresectable, locally advanced or metastatic solitary fibrous tumor (SFT) or extraskeletal myxoid chondrosarcoma (EMC).
    Patients avec tumeurs fireuses solitaires ou chondrosarcome myxoïdes extra squelettiques locallement avancé ou métastatique, non résécable.
    E.1.1.1Medical condition in easily understood language
    Patients with solitary fibrous tumor (SFT) or extraskeletal myxoid chondrosarcoma (EMC) that cannot be removed with surgery, locally advanced or having metastasis
    Patients avec tumeurs fireuses solitaires ou chondrosarcome myxoïdes extra squelettiques locallement avancé ou disséminées, ne pouvant être opérées.
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) in patients with unresectable, locally advanced or metastatic solitary fibrous tumor and extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively.
    Déterminer le Taux de Réponses Objectives (TRO) (réponse complète [CR], et réponse partielle [RP] confirmée) chez des patients porteurs de tumeurs fibreuses solitaires (critères CHOI) et de chondrosarcome myxoïde extra squelettique (RECIST 1.1), non opérable, localement avancé ou métastatique
    E.2.2Secondary objectives of the trial
    - To estimate the efficacy of pazopanib as measured by the progression-free survival (PFS) rate assessed by median time in patients with unresectable, locally advanced or metastatic solitary fibrous tumor and extraskeletal myxoid chondrosarcoma.
    - To evaluate overall survival (OS).
    - To evaluate clinical benefit rate (CBR).
    - To evaluate long term safety profile according to CTCAE 4.0.
    - Estimer l’efficacité du pazopanib mesurée par la survie sans progression (SSP), selon le temps médian à évènement chez des patients porteurs de tumeurs fibreuses solitaires et de chondrosarcome myxoïde extra squelettique, non opérable, localement avancé ou métastatique,
    - Evaluer la survie globale (SG),
    - Evaluer le taux de bénéfice clinique,
    - Evaluer le profil de toxicité à long terme, selon la classification du NCI-CTCAE version 4.0.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational sub-study
    SFT cohort:
    - To perform a central pathologic review (diagnosis confirmation) of paraffin-embedded tumor blocks for each recruited patient with SFT, including (exploratory) STAT6 immunohistochemistry.
    - To evaluate the serum profile of serum cytokine markers as indicator of response to pazopanib. The Luminex technology will be employed for the analysis of 12 cytokines [VEGF-A, PlGF-1, SDF-1 alpha (CXCL12), TNF alpha, IL-8, IL-6, PDGF–beta, HGF, E-Selectine, ICAM1, MMP-9 and FGFb].
    - To evaluate the profile of angiogenic markers in the primary tumor. Microvessel density (MVD) and VEGF/PDGF pathways will be evaluated by IHQ expression as well as their correlation with prognosis and their role as predictive factors to treatment with pazopanib (response, PFS and OS).
    - To evaluate pharmacodynamic markers (MVD, VEGF/PDGF) only in patients with paired samples (in the biopsies taken after treatment).

    EMC cohort:
    - To perform a central pathologic review (diagnosis confirmation) of paraffin-embedded tumor blocks for each recruited patient with EMC, including FISH analysis and/or RT-PCR NR4A3 and its partners (EWSR1, TAF15).
    - To evaluate the expression and activation profile of angiogenic targets (VEGFR, PDGFR, RET, MCSR1) in the primary tumor by immunohistochemistry, pRTK array and IP/WB respectively.
    Etude translationnelle
    Cohorte SFT :
    -Réaliser une relecture anatomopathologique centralisée sur blocs de tumeur archivés inclus en paraffine (confirmation diagnostique) pour tout patient porteur d’une SFT, incluant l’immunomarquage de STAT6 (exploratoire),
    -Evaluer le profil de cytokines comme marqueurs sériques de réponse au pazopanib. La technologie Luminex sera utilisée pour l’analyse de 12 cytokines : VEGF-A, PIGF-1, SDF-1 alpha (CXCL12), TNF alpha, IL-8, IL-6, PDGF-Beta, HGF, E-selectin, ICAM1, MMP-9 and FGFb.
    -Evaluer le profil des marqueurs de l’angiogénèse dans la tumeur primaire. La densité micro vasculaire et les voies VEGF/PDGF seront étudiées par IHC de même que leur corrélation avec des facteurs pronostiques ou prédictifs de réponse au pazopanib (réponse, SSP et SG).
    -Evaluer la pharmacodynamique de marqueurs (MVD, VEGF/PDGF) uniquement chez les patients disposant d’échantillons appariés (matériel disponible avant et après traitement).

    Cohorte EMC :
    -Réaliser une relecture anatomopathologique centralisée sur blocs de tumeurs archivés inclus en paraffine (confirmation diagnostique) pour tout patient porteur d’un EMC, incluant l’analyse de NR4A3 et de ses partenaires (EWSR1, TAF15) en FISH et/ou en RT-PCR (exploratoire),
    -Evaluer l’expression et l’activation de cibles impliquées dans l’angiogénèse (VEGFR, PDGFR, RET, MCSR&) dans la tumeur primaire, en utilisant respectivement l’IHC, pRTK array et IP/WB
    E.3Principal inclusion criteria
    - Written informed consent
    - Age ≥ 18 years
    - Centrally confirmed histologic diagnosis of SFT or EMC
    - ECOG PS <2
    - Measurable disease
    - Maximum of 4 prior metastatic chemotherapy lines
    - Able to swallow
    - Adequate laboratory examinations
    - Effective contraception
    - Adequate Left Ventricular Ejection Fraction
    - Consentement éclairé écrit
    - Age ≥ 18 years
    - Diagnostic histologique de SFT ou EMC confirmé par relecture centralisée.
    - ECOG PS <2
    - Maladie mesurable
    - Maximum de 4 lignes de chimiothérapie antérieures en situation métastatique
    - Capable d'avaler
    - Examens de laboratoires adéquates
    - Contraception efficace
    - Fraction d'Ejection Ventriculaire Gauche adéquate
    E.4Principal exclusion criteria
    - Prior malignancy
    - active Central Nervous System metastasis
    - Prior antiangiogenic agents
    - Clinically significant gastrointestinal abnormalities with bleeding or malabsorption risk
    - QTc > 480 msec
    - History of major cardiovascular condition
    - Poorly controlled hypertension
    - bleeding risk or tumor lesions associated with bleeding risk
    - concomittant prohibited treatment
    - ongoing previous toxicity
    - Antécédent de cancer
    - Métastase du système nerveux central active
    - Traitement antérieur par agents anti-angiogéniques
    - Anomalies gastrointestinales cliniquement significatives associées à un risque de saignement ou de malabsorption
    - QTc > 480 msec
    - Antécédent cardiovasculaire majeur
    - Hypertension non controlée
    - risque de saignement ou lésions tumorales associées à un risque de saignement
    - toxicité antérieure persistante
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]), measured using Choi and RECIST 1.1 criteria. Response criteria will be based on the baseline identification of target lesions and follow-up until tumor progression.
    Taux de Réponses Objectives (TRO) (réponse complète [CR], et réponse partielle [RP] confirmée) chez des patients porteurs de tumeurs fibreuses solitaires (critères CHOI) et de chondrosarcome myxoïde extra squelettique (RECIST 1.1). La réponse sera évaluée à partir des cibles définies en baseline et jusqu’à la progression tumorale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and until disease progression.
    Baseline et jusqu'à progression
    E.5.2Secondary end point(s)
    Efficacy measured by the progression-free survival (PFS) rate assessed by median time.

    Overall survival (OS) measured since treatment start date until date of death, whichever the cause.

    Clinical benefit rate (CBR). Patients who have reached CR, PR or SD during 6 months or more, presenting clinical improvement of symptoms, will be considered as having experienced clinical benefit.

    Long term safety profile of pazopanib, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using NCI-CTCAE 4.0.
    L’efficacité du pazopanib mesurée par la survie sans progression (SSP), sera étudiée selon le temps médian à évènement,
    La survie globale (SG) sera mesurée depuis le début de traitement jusqu’à la date de décès, quelle qu’en soit la cause,
    Le taux de bénéfice clinique sera calculé comme la proportion de patients ayant eu :
    Une réponse partielle ou complète ou une stabilisation de la maladie pendant au moins 6 mois,
    Une amélioration clinique des symptômes,
    Un bénéfice clinique,
    Le profil de toxicité à long terme sera décrit par le type, la fréquence, le délai de survenue et l’imputabilité des évènements indésirables selon la classification du NCI-CTCAE version 4.0, de même que les examens associés.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression-free survival (PFS) rate assessed by median time.

    Overall survival (OS) measured since treatment start date until date of death.

    Patients who have reached CR, PR or SD during 6 months or more, presenting clinical improvement of symptoms, will be considered as having experienced clinical benefit.

    Long term safety profile of pazopanib, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using NCI-CTCAE 4.0.
    Survie sans progression evaluée par la médiane
    Survie globale mesurée du dédut du traitement à la date de décès toute cause.
    Patients ayant obtenu une RC, RP ou MS durant au moins 6 mois, ou ayant présenté une améioration clinique de leurs symptomes seront considérés comme ayant tiré un bénéfice clinique
    Le profil de toxicité à long terme sera décrit par le type, la fréquence, le délai de survenue et l’imputabilité des évènements indésirables selon la classification du NCI-CTCAE version 4.0, de même que les examens associés.
    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 Yes
    E.6.13.1Other scope of the trial description
    Translational (biomarker study)
    Translationnelle (étude de biomarqueurs)
    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.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    The study will be considered closed from a normative point of view after data on primary and secondary variables are sufficiently prepared for its initial publication.
    L'étude sera considérée fermée d'un point de vue normatif lorsque les données relatives à l'évaluation des critères de jugement principaux et secondaires seront considérées suffisantes pour la publication principale
    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: 60
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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
    Néant
    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 Decision2014-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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