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    Summary
    EudraCT Number:2015-004068-13
    Sponsor's Protocol Code Number:HALO-109-301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-07
    Trial results View 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 number2015-004068-13
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
    Étude multicentrique de phase 3, randomisée, en double insu, contrôlée contre placebo, évaluant la hyaluronidase humaine recombinante PEGylée (PEGPH20) associée au nab-paclitaxel plus la gemcitabine par rapport à un placebo associé au nab-paclitaxel plus la gemcitabine chez des patients présentant un adénocarcinome canalaire pancréatique riche en acide hyaluronique, de stade IV, non traité auparavant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating PEGylated Recombinant Human Hyaluronidase (PEGPH20) in previously untreated patients with pancreatic cancer that have high levels of hyaluronan. The study has two groups: all patients will be treated with nab-Paclitaxel plus Gemcitabine. In addition, one group will receive PEGPH20 and the other group will receive an inactive substance. Neither the patient nor the doctor will know the treatment group in which the patient has been randomly assigned to.
    Il s’agit d’une étude évaluant la hyaluronidase humaine recombinante PEGylée (PEGPH20) chez des patients présentant un adénocarcinome canalaire pancréatique riche en acide hyaluronique, non traité auparavant. Les patients éligibles seront randomisés en double insu dans l’un des 2 groupes de traitements suivants: Groupe PAG : PEGPH20 (3,0 μg/kg) + NAB (125 mg/m²) + GEM (1 000 mg/m²) et Groupe AG : Placebo + NAB (125 mg/m²) + GEM (1 000 mg/m²).
    A.4.1Sponsor's protocol code numberHALO-109-301
    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 SponsorHalozyme, Inc.
    B.1.3.4CountryUnited States
    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 supportHalozyme, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHalozyme, Inc.
    B.5.2Functional name of contact pointHalozyme Study Information
    B.5.3 Address:
    B.5.3.1Street Address11388 Sorrento Valley Road
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+15103386053
    B.5.5Fax number+15105958183
    B.5.6E-mailHalozymeMI@dlss.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1394
    D.3 Description of the IMP
    D.3.1Product namePEGylated Recombinant Human Hyaluronidase
    D.3.2Product code PEGPH20
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNProposed INN currently under review: pegvorhyaluronidase alfa
    D.3.9.1CAS number 1620390-06-8
    D.3.9.2Current sponsor codePEGPH20
    D.3.9.3Other descriptive namePEGylated Recombinant Human Hyaluronidase
    D.3.9.4EV Substance CodeSUB33062
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    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) Yes
    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 Yes
    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 ABRAXANE
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaclitaxel bound to human albumin
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Gemcitabine 1g
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgemcitabine hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
    Adénocarcinome canalaire pancréatique riche en acide hyaluronique
    E.1.1.1Medical condition in easily understood language
    Previously Untreated Pancreatic Cancer with High Levels of Hyaluronan
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term Cancer
    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
    • To determine the progression-free survival (PFS) benefit of PEGPH20 combined with nab-paclitaxel (NAB) plus gemcitabine (GEM) (PAG treatment), compared with placebo plus NAB/GEM (AG treatment), in subjects with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA)

    • To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA
    •Déterminer l’effet bénéfique du PEGPH20 associé au nab-paclitaxel (NAB) plus la gemcitabine (GEM) (traitement PAG) sur la survie sans progression (SSP), comparativement à un placebo plus NAB/GEM (traitement AG), chez des patients
    présentant un adénocarcinome canalaire pancréatique (ADP) riche en acide hyaluronique (HA), de stade IV, non traité auparavant
    • Déterminer l’effet bénéfique du traitement PAG sur la survie globale (SG), comparativement au traitement AG, chez des patients présentant un ADP riche en HA, de stade IV, non traité auparavant
    E.2.2Secondary objectives of the trial
    • To determine the objective response rate (ORR) and duration of response (DOR) of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA

    • To assess the safety and tolerability of PAG treatment in subjects with HA-high Stage IV previously untreated PDA
    •Déterminer le taux de réponse objective (TRO) et la durée de la réponse (DDR) du traitement PAG, comparativement au traitement AG, chez des patients présentant un ADP riche en HA, de stade IV, non traité auparavant
    • Évaluer la tolérance et la sécurité d’emploi du traitement PAG chez des patients présentant un ADP riche en HA, de stade IV, non traité auparavant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
    2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic in minimum of 5-10 unstained core biopsy slides that meet specific tissue sample requirements are required.
    3. Subjects must be determined to be HA-high based on tumor biopsy that meets the requirements noted in inclusion criteria #2.
    4. If a subject has had adjuvant therapy (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of adjuvant therapy, provided all toxicities have returned to baseline or ≤ Grade 1.
    1. Signature du formulaire de consentement éclairé ayant reçu un avis favorable du Comité de Protection des Personnes (CPP).
    2. Adénocarcinome canalaire pancréatique (ADP) de stade IV confirmé par l’examen histologique de tissu archivé ou frais (biopsie au trocart) provenant de la lésion primitive ou d’un site métastatique tissu tumoral disponible avec suffisamment de tumeur pour obtenir un minimum de 5 à 10 coupes FFPE consécutives sans coloration ou un bloc archivé répondant aux exigences spécifiques relatives aux échantillons de tissu.
    3. Les tumeurs doivent être déterminées comme étant riches en HA sur la base d’une biopsie tumorale répondant aux exigences mentionnées dans le critère précédent
    4. Si un patient a reçu un traitement adjuvant (chimiothérapie pour cancer du pancréas non métastatique avec ou sans radiothérapie), la survenue d’une récurrence tumorale ou de la progression de la maladie ne doit pas apparaître dans un délai inférieur à au moins 6 mois après la prise de la dernière dose du traitement adjuvant, pourvu qu’un retour au niveau initial ou à un niveau grade 1 de l’ensemble des paramètres de toxicités ait été constaté.
    E.4Principal exclusion criteria
    1. Clinical evidence of DVT, PE or other known TE event present during the screening period.
    2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
    a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
    3. Known central nervous system involvement or brain metastases.
    4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
    5. History of cerebrovascular accident or transient ischemic attack.
    6. Pre-existing carotid artery disease.
    1. Signes cliniques d’une thrombose veineuse profonde (TVP), d’une embolie pulmonaire (EP) ou d’un autre événement TE connu pendant la période de sélection
    2. Antécédents de radiothérapie, de chirurgie, de chimiothérapie ou de traitement à l’étude pour le traitement d’une atteinte métastatique.
    a. Une radiothérapie palliative pour le contrôle de douleurs dues à des lésions osseuses métastatiques est autorisée.
    3.Atteinte connue du système nerveux central ou métastases cérébrales.
    4.Infarctus du myocarde ou maladie cardiaque de Classe III ou IV selon la classification de la New York Heart Association au cours des 12 mois précédents.
    5. Antécédents d’accident vasculaire cérébral (AVC) ou d’accident ischémique transitoire (AIT).
    6. Atteinte préexistante des artères carotides
    E.5 End points
    E.5.1Primary end point(s)
    • Progression-free survival
    • Overall survival
    •Survie sans progression
    •Survie globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final PFS will be conducted at the interim when a pre-specified number of PFS events have occurred. Final OS analysis will be conducted at the end of the study.

    During long-term follow-up information on the subject’s survival and subsequent anticancer therapy will be obtained by the site every 3 months until the subject dies, is lost to follow-up, or withdraws consent. Subjects will be censored for OS at the time of the last “known alive” contact. The OS analysis will be conducted at the end of the study.
    La SSP finale sera évaluée lors de l’AI au seuil de signification de 0,01 lorsque environ 226 événements de SSP seront survenus.

    Après la visite de Fin de traitement, les patients entreront dans une période de suivi à long terme, pendant laquelle le centre recueillera des informations sur la survie du patient et les éventuels traitements anticancéreux ultérieurs tous les 3 mois, jusqu’au décès du patient, ou à une situation de perdu de vue ou de retrait de consentement.
    E.5.2Secondary end point(s)
    • Objective response rate
    • Duration of response
    • Incidence of AEs, changes in clinical safety laboratory values, and changes in cardiovascular parameters (electrocardiogram [ECG] and vital signs)
    •Taux de réponse objective
    • Durée de la réponse
    • Incidence des événements indésirables (EI), modifications des paramètres biologiques de tolérance clinique et modifications des paramètres cardiovasculaires (ECG et signes vitaux)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to protocol for information.
    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 No
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) 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 Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA103
    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
    Australia
    Belgium
    Brazil
    Canada
    China
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Spain
    Taiwan
    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
    The end of the study is defined by the final OS analysis, i.e. when the specified number of events (deaths) is reached.
    La fin de l’étude est définie par l’analyse finale de la SG, qui aura lieu quand le nombre spécifié d’événements (décès) sera atteint.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 231
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 224
    F.4.2.2In the whole clinical trial 420
    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)
    Within 7 days of trial discontinuation, the subject will undergo End of Treatment evaluations including the collection of blood samples and proceed to the long-term follow-up phase which does not require a clinical visit. Enoxaparin treatment will also be stopped at the time of trial discontinuation. The investigator will ensure that consideration has been given to the post-trial medical care of the trial subject’s medical condition.
    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 Decision2016-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-04
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