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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-005177-21
    Sponsor's Protocol Code Number:2015-29
    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:2016-03-14
    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 number2015-005177-21
    A.3Full title of the trial
    Dose-Finding of Propranolol in combination with metronomic fixed oral cyclophosphamide based on Bivariate efficacy-tolerability outcome in patients with locally advanced or metastatic angiosarcoma : A collaborative and innovative phase I-II sequential trial by the French Sarcoma Group (GSF/GETO)
    Etude de determination de dose sur un critère modélisant efficacité-toxicité du Propranolol en association avec le cyclophosphamide métronomique à dose fixe, par voie orale, chez les patients atteints d’angiosarcome localement avancé ou métastatique : essai séquentiel collaboratif et innovant du Groupe Sarcome Français (GSF/GETO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose-Finding of Propranolol in combination with metronomic fixed oral cyclophosphamide based on Bivariate efficacy-tolerability outcome in patients with locally advanced or metastatic angiosarcoma : A collaborative and innovative phase I-II sequential trial by the French Sarcoma Group (GSF/GETO)
    Etude de determination de dose sur un critère modélisant efficacité-toxicité du Propranolol en association avec le cyclophosphamide métronomique à dose fixe, par voie orale, chez les patients atteints d’angiosarcome localement avancé ou métastatique : essai séquentiel collaboratif et innovant du Groupe Sarcome Français (GSF/GETO)
    A.3.2Name or abbreviated title of the trial where available
    PROPAN01
    PROPAN01
    A.4.1Sponsor's protocol code number2015-29
    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 SponsorAssistance Publique Hôpitaux de MARSEILLE
    B.1.3.4CountryFrance
    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 supportPHRC Cancer 2014
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique Hôpitaux de MARSEILLE
    B.5.2Functional name of contact pointArnaud VANNESTE
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche 80 Rue Brochier
    B.5.3.2Town/ cityMarseille CEDEX 05
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number+33491382747
    B.5.5Fax number+33491381479
    B.5.6E-mailpatrick.sudour@ap-hm.fr
    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 AVLOCARDYL 40mg
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA
    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.3.1Product nameAVLOCARDYL
    D.3.2Product code Propranolol
    D.3.4Pharmaceutical form Cachet
    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 INNChlorhydrate de Propranolol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    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 PROPANOLOL TEVA LP 80mg
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA SANTE
    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.3.1Product namePropranolol 80mg LP
    D.3.2Product code Propranolol
    D.3.4Pharmaceutical form Prolonged-release 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 INNChlorhydrate de propranolol
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80 to 160
    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.IMP: 3
    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 PROPRANOLOL TEVA LP 160mg
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA
    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.3.1Product namePropranolol 160mg LP
    D.3.2Product code Propranolol
    D.3.4Pharmaceutical form Prolonged-release 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 INNChlorhydrate de propranolol
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 presenting angiosarcomas disease
    Patients présentant un angiosarcome
    E.1.1.1Medical condition in easily understood language
    Patients prsenting angiosarcomas disease
    Patients présentant un angiosarcome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the optimal dose of propranolol (out of 80 mg/d; 120 mg/d and 160 mg/d) in terms of toxicity and efficacy assessed by non-progression rate at 3 months in patients with angiosarcomas treated by fixed dose of oral cyclophosphamide
    L’objectif principal de cette étude est de déterminer la dose optimale de propranolol (parmi : 80 mg/j ; 120 mg/j and 160 mg/j) en termes de toxicité et d’efficacité évaluée par le taux de non-progression à 3 mois chez des patients présentant un angiosarcome localement avancé ou métastatique, traité par doses orales fixes de cyclophosphamide.
    E.2.2Secondary objectives of the trial
    The second objectives of this study are the following:
    - Response rate at 3, 6 and 9 months (according to RECIST 1.1 guidelines and after central radiological review)
    - Progression free survival (from the date of inclusion to the date of documented progression or date of last follow-up)
    - Growth modulation index (GMI=time to progression under study treatment divided by the time to progression under the prior treatment)
    - Overall survival (from the date to inclusion to the date of death or last follow-up)
    - Tolerability of combination propranolol and oral cyclophosphamide according to NCI-CTC AE Version 4.0
    Les objectifs secondaires sont les suivants:
    - Taux de réponse à 3, 6 et 9 mois (selon les critères RECIST 1.1 et après revue radiologique centralisée)
    - Survie sans progression (de l’évaluation radiographique de la baseline à la progression documentée ou jusqu’à la date de dernier follow-up
    - Indice de modulation de la croissance (temps jusqu’à progression sous traitement à l’étude divisé par le temps jusqu’à progression sous le traitement précédent)
    - Survie globale (de la date d’inclusion à la date du décès ou du dernier follow-up)
    - Tolérance de la combinaison de propranolol et cyclophosphamide orale selon les NCI-CTCAE Version 4.0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Man or woman 18 years old or over and a World Health Organization performance status score ≤ 2 PS;
    - Adolescents > 15 years with body surface > 1.6 m2

    • Subject with an Histologically proven angiosarcoma, reviewed by an independent pathologist, with metastasis or locally advanced stage not amenable to radiotherapy or curative-intent surgery after multidisciplinary decision making;
    • Subject with Prior systemic treatment with paclitaxel or doxorubicin;
    • Subject with angiosarcoma with an indication and prescription of treatment by oral cyclophosphamide after multidisciplinary decision making;
    • Subject with no more than two prior lines of chemotherapy (whatever the indication);
    • Subjects with absence of brain or meningeal metastasis;
    • Subject with at least one lesion measurable according to the RECIST, version 1.1;
    • Subject with neutrophil count ≥1,000/mm3, platelet count ≥ 100 000/mm3, hemoglobin level ≥ 8 g/Dl, liver transaminases ≤ 1.5 x ULN, total bilirubin ≤ 1.5 x ULN, serum creatinine ≤ 1.5 x ULN, and amylase and lipase ≤ 1.5 x ULN.
    - Homme ou femme >18 ans
    - Adolescents > 15 years avec une surface corporelle >1,6 m2
    - Angiosarcome prouvé histologiquement (revu par un anatomopathologiste indépendant), localement avancé ou métastatique, non eligible à la radiothérapie ou à une chirurgie curative après concertation multidisciplinaire
    - Traitement systémique antérieur par Paclitaxel ou Doxorubicine
    - Présence d’au moins une lésion mesurable selon les RECIST 1.1
    - Absence de métastases cérébrales
    - Pas plus de deux lignes de chimiothérapies antérieures (quelque soit l’indication)
    - Un score WHO (World Health Organization) ≤2
    - Paramètres biologiques adéquats, soit:
    Numeration leucocytaire ≥3,000/mm3, plaquettes ≥100,000/mm3, hémoglobine ≥ 8 g/Dl, transaminases ≤1.5 XULN, bilirubine totale ≤1.5X ULN, creatinine≤1.5XULN, amylase et lipase≤1.5XULN
    E.4Principal exclusion criteria
    • Minors or pregnant or breast-feeding women.
    • Subject with a contraindication to propranolol (ie cardiogenic shock; sinus bradycardia and greater than first-degree block; Chronic Obstructive Pulmonary Disease and bronchial asthma; patients with known hypersensitivity to Propranolol; assessed by cardiovascular and pulmonar history and examinations including blood pressure, ECG; untreated Pheochromocytoma, Congestive heart failure not controlled by treatment, Prinzmetal’s angina)
    • Subject with Severe Raynaud Phenomena or Raynaud Disease
    • Subject with Prior systemic treatment with Cyclophosphamide as 1st or 2nd line
    - Mineurs ≤ 15ans, femmes enceintes ou allaitantes
    - Sujets présentant une contre-indication au propranolol (ie choc cardiogénique; bradycardie sinusale et bloc cardiaque supérieur à un 1er degré ; Maladie pulmonaire obstructive chronique et asthme; patients avec hypersensibilité connue au propranolol; évalués selon l’histoire médicale pulmonaire et cardiovasculaire et à partir des examens incluant la mesure de la tension artérielle et ECG; pheochromocytome non traité, insuffisance cardiaque congestive non contrôlé par un traitement, angor de Prinzmetal)
    - Sujets présentant un syndrome de Raynaud sévère
    - Sujets ayant reçu du cyclophosphamide en 1ère ou 2ème ligne
    E.5 End points
    E.5.1Primary end point(s)
    This dose-finding study will jointly model the toxicity and the efficacy as primary endpoints:
    - The toxicity of propranolol is well described on humans as well as its pharmacokinetic (Peak plasma concentrations occur about 1 to 4 hours) after oral dose and pharmacodynamics characteristics with the main target on beta-adrenergic receptor (blocking agent possessing no other autonomic nervous system activity). In this study the toxicity of each tested propranolol dose level in association to cyclophosphamide will be assessed according to NCI-CTC AE Version 4.0 at 1 month (Recording AE, Blood pressure, and electrocardiography). A dose-limiting toxicity (DLT) will be considered as any grade 3 or higher specially cardiac and hematologic but also non-hematologic toxicity that is probably or definitely related to treatment.
    - The efficacy criterion is defined as the non-progression rate at 3 months according to RECIST 1.1 guidelines and with central radiological review.
    Cette étude de recherche de doses modèlise conjointement la toxicité et l’efficacité en tant que critères d’évaluation primaires :
    - La toxicité du propranolol est bien décrite chez les sujets ainsi que ses caractéristiques pharmacocinétiques (pics de concentrations plasmatiques apparaissant de 1 à 4 heures après la dose orale) et pharmacodynamiques avec une cible principale sur les récepteurs bêta-adrénergiques
    Dans cette étude, la toxicité de chaque palier de dose de propranolol testé en association avec le cyclophosphamide sera évaluée selon les NCI-CTC AE Version 4.0 à 1 mois (enregistrement des AEs, pression artérielle, et électrocardiographie).
    Toute toxicité de grade 3 plus spécifiquement cardiaque et hématologique mais également toute toxicité non hématologique probablement ou définitivement reliée au traitement, sera considérée comme étant une toxicité dose-limitante.
    Le critère d’efficacité est défini comme un taux de non-progression à 3 mois selon les critères RECIST 1.1 et la revue radiologique centrale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Toxicity will be assessed at 1 month
    Efficacy will be assessed at 3 months
    L'évaluation de la toxicité aura lieu à un mois de la prise du traitement et l'efficaicté à 3 mois
    E.5.2Secondary end point(s)
    •Response rate
    •Progression free survival
    •Growth modulation index
    •Overall survival
    •Tolerability
    •Taux de réponse
    •Survie sans progression
    •Growth modulation index
    •Taux de sruvie global
    •Tolérance du traitement
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Response rate at 3, 6 and 9 months (according to RECIST 1.1 guidelines and after central radiological review)

    •Progression free survival
    Progression free survival will be defined from the date of inclusion to the date of documented progression or date of last follow-up.

    •Growth modulation index
    GMI will be defined by the time to progression under study treatment divided by the time to progression under the prior treatment

    •Overall survival
    Overall survival will be defined as the time from baseline evaluation until death due to any cause (linked or not to the disease).

    •Tolerability of combination propranolol and oral cyclophosphamide according to NCI-CTC AE Version 4.0
    •Taux de réponse sera mesuré à 3,6 et 9 mois en accord avec la revue centralisée des radioe et les recommandations RECIST1.1

    •Survie sans progression est défini comme le temps entre la date d'inclusion du sujet et la date de la progression de la maladie ou du dernier suivi dans le cadre du projet
    • Index de progression est défini comme le temps avant progression sous traitemeent à l'étude divisé par le temps avant progression avec le dernier traitement.
    •Taux de survie global est défini par le temps entre l'évaluation initiale jusqu'au décés du patient en lien ou non avec la maladie
    •Tolérance du traitement combinant le propranolol et le cyclophosphamide en accord avec le NCI-CTC AE Version 4.0
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    PhaseI/II
    Phase I/II
    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 concerned11
    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 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
    LVLS
    Derniere visite du dernier sujet en cours de particpation dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months33
    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 Yes
    F.1.1Number of subjects for this age range: 2
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 6
    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 state24
    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
    aucun
    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 Decision2016-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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