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    The EU Clinical Trials Register currently displays   40109   clinical trials with a EudraCT protocol, of which   6567   are clinical trials conducted with subjects less than 18 years old.
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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2014-000148-14
    Sponsor's Protocol Code Number:PLX108-10
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-04-14
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-000148-14
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath
    Ensayo de fase III aleatorizado, con doble enmascaramiento y controlado con placebo de PLX3397 administrado por vía oral en pacientes con sinovitis vellonodular pigmentada o tumor de células gigantes de la vaina tendinosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial comparing the effectiveness of PLX3397 against placebo in the treatment of Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath
    Un ensayo clínico comparando la ecficacia de PLX3397 versus placebo en el tratamiento de la sinovitis vellonodular pigmentada o tumor de células gigantes de la vaina tendinosa
    A.4.1Sponsor's protocol code numberPLX108-10
    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 SponsorDaiichi Sankyo Development Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDaiichi Sankyo Development Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportDaiichi Sankyo Pharma Development
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDaiichi Sankyo Company, Limited
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Limited
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34917081250
    B.5.5Fax number+34917081301
    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 No
    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 namePLX3397
    D.3.2Product code PLX3397
    D.3.4Pharmaceutical form Capsule
    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 INNNone
    D.3.9.1CAS number 1029044-16-3
    D.3.9.2Current sponsor codePLX3397
    D.3.9.3Other descriptive namePLX3397 HCL
    D.3.9.4EV Substance CodeSUB33175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pigmented villonodular synovitis (PVNS) / giant cell tumour of tendon sheath (GCT-TS)
    Sinovitis vellonodular pigmentada (SVP) / tumor de células gigantes de la vaina tendinosa (TCG-VT)
    E.1.1.1Medical condition in easily understood language
    tumour of the tendon sheath
    Tumor de la vaina tendinosa
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10062856
    E.1.2Term Giant cell tumour of tendon sheath benign
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the response rate of PLX3397 with that of placebo per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at Week 25 in subjects with symptomatic, locally advanced PVNS or GCT-TS.
    El objetivo principal de este estudio es comparar la tasa de respuesta de PLX3397 frente a la de placebo según los Criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST 1.1) en la semana 25 en pacientes con SVP o TCG-VT localmente avanzados y sintomáticos
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to evaluate: (i) patient-reported outcomes (PROs), including the Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) item, Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Scale, and Worst Stiffness NRS item, at Week 25; (ii) response based on TVS at Week 25; (iii) range of motion at Week 25; and (iv) duration of response.
    Los objetivos secundarios de eficacia del estudio son evaluar: (i) los resultados percibidos por los pacientes (PRO), que incluyen el resultado de dolor más intenso en la escala de valoración numérica (EVN) del Cuestionario breve para la evaluación del dolor (Brief Pain Inventory, BPI), la escala de función física del Sistema de información sobre la medición de los resultados percibidos por los pacientes (Patient-reported Outcomes Measurement Information System, PROMIS) y el peor resultado de rigidez en la EVN en la semana 25; (ii) la respuesta según la Puntuación de volumen tumoral (Tumor Volume Score, TVS) en la semana 25; (iii) el rango de movilidad en la semana 25; y (iv) la duración de la respuesta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ? 18 years.
    2. A diagnosis of PVNS or GCT-TS (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi-disciplinary tumor board).
    3. Measurable disease of at least 2 cm and otherwise based on RECIST 1.1, assessed from MRI scans by a central radiologist.
    4. Symptomatic disease because of active PVNS or GCT-TS, defined as one or more of the following:
    a. a worst pain of at least 4 at any time during the preceding week (based on scale of 0 to 10, with 10 representing ?pain as bad as you can imagine?).
    b. a worst stiffness of at least 4 at any time during the preceding week (based on a scale of 0 to 10, with 10 representing ?stiffness as bad as you can imagine?).
    5. Stable analgesic regimen during the 2 weeks prior to randomization.
    6. During the week prior to randomization, at least 4 days of BPI Worst Pain NRS items and Worst Stiffness NRS items completed correctly.
    7. Women of childbearing potential must have a negative serum pregnancy test within the14-day period prior to randomization. (Where demanded by local regulations, this test may be required within 72 hours of randomization.)
    8. Male and female subjects of childbearing potential are permitted in the study so long as they consent to avoid getting their partner pregnant or becoming pregnant, respectively, by using a highly effective contraception method, as described below, throughout the study and for up to 90 days after completion. Highly effective methods of contraception include: hormonal methods associated with inhibition of ovulation, intra-uterine device; surgical sterilization (including partner?s vasectomy) or sexual abstinence.
    Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year. Women who have documentation of at least 12 months of spontaneous amenorrhea and have an FSH level >40 mIU/mL will be considered postmenopausal.
    9. Adequate hematologic, hepatic, and renal function, defined by:
    ? Absolute neutrophil count ? 1.5 × 109/L ? AST/ALT ? 1.5 × ULN
    ? Hemoglobin > 10 g/dL ? Total bilirubin ? 1.5 × ULN
    ? Platelet count ? 100 × 109/L ? Serum creatinine ? 1.5 × ULN
    10. Willingness and ability to complete the BPI Worst Pain NRS item, Worst Stiffness NRS item, PROMIS Physical Function Scale, and other self-assessment instruments throughout the study.
    11. Willingness and ability to use an electronic diary.
    12. Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
    1. Edad ? 18 años.
    2. Un diagnóstico de SVP o TCG-VT (i) que haya sido confirmado histológicamente por un patólogo en el centro responsable del tratamiento o un patólogo centralizado, y (ii) para el que la resección quirúrgica se asociaría a un posible empeoramiento de la limitación funcional o a una morbilidad grave (enfermedad localmente avanzada), con una morbilidad determinada por consenso entre personal cualificado (por ejemplo, dos cirujanos o una junta multidisciplinaria de oncología).
    3. Una enfermedad medible de al menos 2 cm o basada en los criterios RECIST 1.1, evaluada mediante RM por un radiólogo centralizado.
    4. Una enfermedad sintomática causada por de SVP o TCG-VT activos, definida como uno o más de los casos siguientes:
    a. una puntuación de dolor más intenso de al menos 4 en cualquier momento de la semana precedente (basada en una escala del 0 al 10, donde 10 representa "el peor dolor imaginable").
    b. una puntuación de rigidez más intensa de al menos 4 en cualquier momento de la semana precedente (basada en una escala del 0 al 10, donde 10 representa "la peor rigidez imaginable").
    5. Tratamiento analgésico estable durante las 2 semanas previas a la aleatorización.
    6. Durante la semana previa a la aleatorización, al menos 4 días de resultados de dolor más intenso de la EVN del BPI y de la EVN de peor rigidez completados correctamente.
    7. Las mujeres que puedan quedarse embarazadas deben presentar una prueba de embarazo en suero negativa en el plazo de 14 días anteriores a la aleatorización (podría ser necesario realizar esta prueba en el plazo de 72 horas antes de la aleatorización, si así lo exigen las normativas locales).
    8.Se permiten en el estudio varones y mujeres en edad fértil, siempre y cuando consientan, para evitar dejar embarazada a su pareja o quedar embarazada, respectivamente, el uso de un método anticonceptivo muy eficaz, como se describe a continuación, durante el estudio y hasta 90 días después de la finalización. Los métodos anticonceptivos altamente eficaces incluyen: métodos hormonales asociados con la inhibición de la ovulación, el dispositivo intrauterino; esterilización quirúrgica (incluyendo la vasectomía de la pareja) o la abstinencia sexual. Las mujeres no fértiles pueden incluirse bien, si están esterilizadas quirúrgicamente, o bien si han sido postmenopáusica por ?1 año. Mujeres que tienen documentación de al menos 12 meses de amenorrea espontánea y tener un nivel de FSH> 40 mUI / mL se considerarán posmenopáusicas
    9. Funciones hematológica, hepática y renal adecuadas, definidas por:
    ? Recuento absoluto de neutrófilos ? 1,5× 109/L ?AST/ALT ? 1,5 veces el LSN
    ? Hemoglobina > 10 g/dL ? Bilirrubina ? 1,5 veces el LSN
    ? Número de trombocitos ? 100 × 109/L ? Creatinina sérica ? 1,5 veces el LSN
    10. Voluntad y capacidad para completar el resultado de dolor más intenso de la EVN del BPI, el resultado de peor rigidez de la EVN, la escala de función física del Sistema PROMIS y otros instrumentos de autoevaluación a lo largo del estudio.
    11. Voluntad y capacidad para usar un diario electrónico.
    12. Voluntad y capacidad para proporcionar un consentimiento informado por escrito previo a cualquiera de los procedimientos relacionados con el estudio y satisfacer todos los requisitos del estudio.
    E.4Principal exclusion criteria
    1. Investigational drug use within 28 days of randomization.
    2. Previous use of PLX3397 or any biologic treatment targeting CSF-1 or the CSF1R; previous use of oral tyrosine kinase inhibitors, eg, imatinib or nilotinib, are allowed.
    3. Active cancer (either concurrent or within the last year of starting study treatment) that requires non-surgical therapy (eg, chemotherapy or radiation therapy), with the exception of PVNS/GCT TS, surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix. Prostate and breast cancer in remission (not receiving active therapy) for > 5 years will be allowed.
    4. Known metastatic PVNS/GCT-TS.
    5. Active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus or known active or chronic infection with human immunodeficiency virus.
    6. Known active tuberculosis.
    7. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the investigator?s opinion, would likely interfere with the person?s study participation or the interpretation of his or her results.
    8. Women who are breastfeeding.
    9. A screening Fridericia corrected QT interval (QTcF) ? 450 ms (men) or ? 470 ms (women).
    10. MRI contraindications.
    1. Uso del fármaco en investigación durante los 28 días anteriores a la aleatorización.
    2. Uso previo de PLX3397 o cualquier otro tratamiento biológico dirigido al factor 1 de estimulación de colonias (CSF-1) o al receptor del CFS-1; se permite el uso previo de inhibidores orales de la tirosina quinasa, como imatinib o nilotinib.
    3. Cáncer activo (ya sea concurrente o durante el último año antes de iniciar el tratamiento del estudio) que requiera tratamiento no quirúrgico (por ejemplo, quimioterapia o radioterapia), con la excepción de SVP/TCG-VT, carcinoma basocelular o escamoso de la piel tratado quirúrgicamente, melanoma in situ o carcinoma in situ del cuello uterino. Se permite cáncer de mama o de próstata en remisión (que no recibe tratamiento activo) durante > 5 años.
    4. Diagnóstico de SVP/TCG-VT metastásico.
    5. Infección activa o crónica por el virus de la hepatitis C o de la hepatitis B o diagnóstico de infección activa o crónica por el virus del VIH.
    6. Diagnóstico de tuberculosis activa.
    7. Artropatía concomitante significativa en la articulación afectada, enfermedad grave, infección no controlada o antecedentes médicos o psiquiátricos que según el criterio del investigador podrían interferir con una adecuada participación del candidato en el estudio o la correcta interpretación de sus resultados.
    8. Mujeres en periodo de lactancia.
    9. Un intervalo QT ajustado por la fórmula de Fridericia (QTcF) en el momento de la selección ? 450 ms (varones) o ? 470 ms (mujeres).
    10. Contraindicación de RM.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who achieve a complete or partial response at the Week 25 visit based on centrally read MRI scans and RECIST 1.1.
    La proporción de pacientes que alcance una respuesta completa (RC) o una respuesta parcial (RP) en la visita de la semana 25 en función de las lecturas centralizadas de las RM y los criterios RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 25
    Semana 25
    E.5.2Secondary end point(s)
    1. Proportion of responders based on the BPI Worst Pain NRS item and analgesic use by BPI-30 definition (as defined in Section 7.6.2)
    2. Proportion of responders based on centrally evaluated MRI scans and TVS at the Week 25 visit
    3. Mean change from baseline in range of motion of the affected joint, relative to a reference standard for the same joint, at the Week 25 visit
    4. Mean change from baseline score in the PROMIS Physical Function Scale at the Week 25 visit
    5. Mean change from baseline score in the Worst Stiffness NRS item at the Week 25 visit
    6. Duration of response (CR or PR) based on MRI and RECIST 1.1
    7. Duration of response (CR or PR) based on MRI and TVS
    ? Proporción de pacientes que presenten respuesta al tratamiento en función del resultado de dolor más intenso de la EVN del BPI y el uso de analgésicos según la definición del cuestionario BPI-30 (como se definió en la sección 7.6.2)
    ? Proporción de pacientes que presenten respuesta al tratamiento en función de la evaluación centralizada de las RM y la TVS en la visita de la semana 25.
    ? Cambio medio respecto al periodo basal en el rango de movimiento de la articulación afectada, en relación al estándar de referencia para dicha articulación, en la visita de la semana 25.
    ? Cambio medio respecto al periodo basal en la escala de función física del Sistema PROMIS en la visita de la semana 25.
    ? Cambio medio respecto al periodo basal en la puntuación de peor rigidez de la EVN en la visita de la semana 25.
    ? Duración de la respuesta (RC o RP) en función de las RM y los criterios RECIST 1.1.
    ? Duración de la respuesta (RC o RP) en función de las RM y la TVS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 25
    Semana 25
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 126
    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)
    Subjects who complete Part 2 will be eligible to enter a separate protocol to continue receiving PLX3397 until disease progression, unacceptable toxicity, or the ocurrence of other termination criteria.
    Los sujetos que completen la parte 2 podrán ser elegidos para entrar en un protocolo separado para continuar recibiendo PLX3397 hasta progresión de la enfermedad, toxicidad inaceptable u ocurrencia de otros citerios de finalización
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-13
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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