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    Summary
    EudraCT Number:2012-003592-19
    Sponsor's Protocol Code Number:NEOPAX-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 number2012-003592-19
    A.3Full title of the trial
    Evaluation of tumoral perfusion modification by dynamic imaging after chemotherapy combining gemcitabine and nab-paclitaxel (Abraxane) in patients with potentially operable, locally advanced or metastatic pancreatic adenocarcinoma
    Evaluation des modifications de perfusion tumorale par imagerie dynamique après une chimiothérapie combinant gemcitacine et nab-paclitaxel (Abraxane) chez des patients atteints d'adénocarcinome pancréatique potentiellement opérable, localement avancé ou métastatique
    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 in patients with operable, locally advanced or metastatic pancreas cancer
    Evaluation de l'effet d'une chimiothérapie combinant deux molécules chez des patients atteints de cancer du pancréas opérable, localement avancé ou métastatique
    A.3.2Name or abbreviated title of the trial where available
    NEOPAX-001
    A.4.1Sponsor's protocol code numberNEOPAX-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 supportCelgene bvba/sprl
    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+322555 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 Yes
    D.2.1.1.1Trade name Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom
    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.3.1Product nameAbraxane
    D.3.4Pharmaceutical form Concentrate 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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) 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 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
    Resectable (cohort 1) and locally advanced or metastatic (cohort 2) pancreatic ductal adenocarcinoma
    Adénocarcinome ductal pancréatique résécable (cohorte 1) et localement avancé ou métastatique (cohorte 2)
    E.1.1.1Medical condition in easily understood language
    Operable (cohort 1) and locally advanced/metastatic (cohort 2) pancreas cancer
    Cancer du pancréas opérable (cohorte 1) et localement avancé ou métastatique (cohorte 2)
    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 prospectively evaluate the performance of DCE/DW-MRI (Dynamic Contrast-Enhanced/Diffusion Weighted-Magnetic Resonance Imaging) in assessing the “dynamic” tumor response rate after the administration of a short course combination of gemcitabine and nab-paclitaxel (Abraxane) during (a) a window interval of 3 weeks (=1 cycle) before the planned surgery in resectable pancreatic cancer (cohort 1) and (b) at least two cycles in metastatic or locally advanced pancreatic cancer (cohort 2).
    E.2.2Secondary objectives of the trial
    - to correlate the observed dynamic imaging parameters to the histopathological tumoral changes in order to further categorize patients subpopulations;
    - to identify within pre-therapeutic samples and surgical specimens specific biomarkers involved (1) in the nab-paclitaxel activity (SPARC, taxanes-related biomarkers immunohistochemical patterns expression) and predicting response to Abraxane therapy, (2) in the intracellular uptake (hENT1) and activation (dCK) of gemcitabine and predicting response to gemcitabine therapy, and (3) in the relative contribution of both Abraxane and gemcitabine therapy;
    - to compare the obtained data with those collected from the evaluation with gemcitabine alone in a similar protocol;
    - to use the biomarkers and dynamic imaging-driven clinical platform parameters to properly define a “dynamic and biomolecular” response or non response to preoperative therapy, which would be able to predict the benefiters of such strategy (patient outcome).
    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 (cohort 1), or locally advanced and/or metastatic tumor (cohort 2);
    - 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
    - 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 complete remission 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; patients previously enrolled into this study.
    E.5 End points
    E.5.1Primary end point(s)
    “Dynamic” tumor response rate after (a) gemcitabine and Abraxane preoperative treatment exposure (3 weeks= 1 cycle) for resectable pancreatic cancer (cohort 1) and (b) gemcitabine and Abraxane treatment exposure (at least 2 cycles) for metastatic or locally advanced pancreatic cancer (cohort 2). The dynamic tumor response rate will be defined by a 40% modification of tumoral perfusion status and/or ADC status determined by quantitative DCE/DW-MRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort 1: Screening, Week 1 (before chemotherapy Week 1), Week 2 (before chemotherapy Week 2), Week 3 (before chemotherapy Week 3) and day before surgery.
    Cohort 2: Screening and before each administration of chemotherapy
    E.5.2Secondary end point(s)
    For cohort 1 (resectable primary tumor):
    - Correlation between tumoral mean vessel density (MVD) counts evaluated by immunostaining with CD31 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 plasma Stromal Cell-Derived Factor-1 (SDF-1 level);
    - Pathological evaluation of tumor changes (stroma, vascular density, stellate cells, stem cells, tumor regression);
    - Evaluation of both markers of gemcitabine and nab-paclitaxel activity : nucleoside transporters hENT1, dCK, CDA, SPARC, taxanes-related biomarkers;
    - Feasibility and toxicity of the whole therapeutic sequence (Abraxane + gemcitabine + surgery

    For cohort 2 (locally advanced and/or metastatic lesions):
    - Correlation with the RECIST response by CT or MRI obtained at 8 weeks;
    - Stromal ( fibrosis) pattern evaluation between the primary and secondary lesions ( DCE/DW-MRI and pathological pattern if available);
    - Idem cohort 1 in case of obtaining tissue.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cohort 1: post surgery
    Cohort 2: after at least 2 cycles of therapy
    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.8.3 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 months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state31
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-30
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