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    Summary
    EudraCT Number:2012-003516-31
    Sponsor's Protocol Code Number:NEOPACHI-001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-003516-31
    A.3Full title of the trial
    Evaluation of tumoral perfusion modification by dynamic imaging after neoadjuvant chemotherapy combining gemcitabine and a Hedgehog inhibitor (Vismodegib) in patients with resectable pancreatic adenocarcinoma
    Evaluation des modifications de la perfusion tumorale par imagerie dynamique après l'administration d'une chimiothérapie combinant gemcitabine et un inhibiteur de la voie Hedgehog (Vismodegib) chez les patients atteints d'un adénocarcinome pancréatique potentiellement résécable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of the effect of a chemotherapy combining two molecules administred before surgery in patients with pancreas cancer
    Evaluation de l'effet d'une chimiothérapie combinant deux molécules administrées avant opération chez des patients atteints d'un cancer du pancréas
    A.3.2Name or abbreviated title of the trial where available
    NEOPACHI-001
    A.4.1Sponsor's protocol code numberNEOPACHI-001
    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 SponsorCUB Erasme Hospital
    B.1.3.4CountryBelgium
    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 supportRoche
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCUB Erasme Hospital
    B.5.2Functional name of contact pointJean-Luc Van Laethem
    B.5.3 Address:
    B.5.3.1Street AddressRoute de Lennik 808
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322555 30 16
    B.5.5Fax number+32 2555 82 36
    B.5.6E-mailjl.vanlaethem@erasme.ulb.ac.be
    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 nameVismodegib
    D.3.2Product code GDC-0449
    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 INNGDC-0449
    D.3.9.1CAS number 879085-55-9
    D.3.9.3Other descriptive nameVISMODEGIB
    D.3.9.4EV Substance CodeSUB32354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Potentially resectable pancreatic ductal adenocarcinoma
    Adénocarcinome ductal pancréatique potentiellement résécable
    E.1.1.1Medical condition in easily understood language
    Operable pancreatic cancer
    Cancer du pancréas opérable
    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
    To evaluate the “dynamic” tumor response by DCE-MRI and tumor modifications after the administration of a short course (4 weeks) neoadjuvant combination of gemcitabine and Vismodegib before surgery
    Evaluer la réponse tumorale "dynamique" par DCE-MRI et les modifications tumorales après l'administration d'une courte thérapie néoadjuvante (4 semaines) combinant gemcitabine et Vismodegib avant chirurgie
    E.2.2Secondary objectives of the trial
    - To identify new targets involved in the Hedgehog signaling pathway and new biomarkers predicting response to anti Hh therapy (and the relative contribution of both anti-Hh therapy and gemcitabine therapy);
    - To compare the obtained data with those from the evaluation with gemcitabine alone.
    - Identifier de nouvelles cibles impliquées dans la voie de signalisation hedgehog, et de nouveaux biomarqueurs prédictifs de la réponse aux anti-hedgehog (et la contribution relative de la thérapie anti-hedgehog et de la thérapie à base de gemcitabine);
    - comparer les données obtenues avec celles obtenues avec de la gemcitabine en monothérapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histo(cyto)logically proven ductal pancreatic adenocarcinoma;
    • Resectable or potentially resectable tumor; resectability assessed during a multidisciplinary meeting with expert surgeon and radiologist;
    • First line chemotherapy;
    • Age > 18 years;
    • WHO performance status (PS) grade 0 or 1;
    • Absolute neutrophil count > 1.5 x 10 9 / L, platelets > 100 x 10 9/ L, creatinine clearance (Cockroft and Gault formula) > 60 ml/min, haemoglobin level > 10 g/dl (transfusions authorized), bilirubin<1.5 g/dl;
    • Optimal biliary drainage;
    • Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation of who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study;
    • Written informed consent.
    E.4Principal exclusion criteria
    • Locally advanced non resectable or metastatic pancreatic adenocarcinoma;
    • Previous anticancer therapy for the pancreatic adenocarcinoma;
    • Biliary obstruction without endoscopic biliary drainage;
    • Any contre-indication for surgery;
    • Prior malignancy (except non-melanoma skin cancer, and in situ carcinoma of the uterine cervix treated with a curative intent and any other tumor in CR with a disease-free interval > 3 years);
    • Uncontrolled congestive heart failure or angina pectoris, myocardial infarction within 1 year prior to study entry, uncontrolled hypertension (systolic pressure > 160 mm or diastolic pressure > 100 mm under well conducted antihypertensive treatment), QT prolongation;
    • Major uncontrolled infection;
    • Severe hepatic impairment;
    • Any medical, psychological, or social condition, which, in the opinion of the investigator, could hamper patient’s compliance to the study protocol and/or assessment/interpretation of the data;
    • Pregnant or lactating women, or patients of both genders with procreative potential not using adequate contraceptive methods;
    • Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study;Subject previously enrolled into this study.
    E.5 End points
    E.5.1Primary end point(s)
    “Dynamic” tumor response rate after preoperative treatment exposure, which is defined by a 20% modification of tumoral perfusion status determined by quantitative DCE/DW-MRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Week 1 (pre-gemcitabine chemotherapy infusion n°1), Week 2 (pre-gemcitabine chemotherapy infusion n°2), , Week 3 (pre-gemcitabine chemotherapy infusion n°3), Week 4 (pre-gemcitabine chemotherapy infusion n°4), Day before surgery
    E.5.2Secondary end point(s)
    - Correlation between tumoral changes (stromal, microvascular, epithelial components) on pathologic samples (pre and post therapeutic) and quantitative parameters relative to perfusion tissue and apparent diffusion coefficient (ADC) determined by DCE/DW-MRI;
    - Evaluation of other efficacy markers in stromal and vascular microenvironment of tumor cells: decrease of the desmoplastic reaction, improvement of the microvascular density, downregulation of Hedgehog signalling pathway, modulation of stellate /cancer stem cells;
    - Safety and feasibility of the whole therapeutic sequence (gemcitabine + Hh inhibitor + surgery
    - Identification of predictive factors of response to anti-Hedgehog and gemcitabine;
    - Disease-free survival (DFS) and overall survival (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Post surgery
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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 concerned2
    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 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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned 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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state21
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-03
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