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    Summary
    EudraCT Number:2013-004101-75
    Sponsor's Protocol Code Number:S56122-ML10190
    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:2014-01-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-004101-75
    A.3Full title of the trial
    Randomized crossover trial to assess the effects and quality of life in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine in combination with nab-paclitaxel: QOLINPAC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Quality of life study in patients with pancreatic cancer receiving gemcitabine in combination with nab-paclitaxel or gemcitabine alone
    A.3.2Name or abbreviated title of the trial where available
    QOLINPAC
    A.4.1Sponsor's protocol code numberS56122-ML10190
    A.5.4Other Identifiers
    Name:Celgene internal numberNumber:AX-CL-PANC-PI-003568
    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 SponsorUZ Leuven
    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 supportUZLeuven
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBelgian Group of Digestive Oncology
    B.5.2Functional name of contact pointNathalie Verbist
    B.5.3 Address:
    B.5.3.1Street AddressLeuvensesteenweg 643
    B.5.3.2Town/ city Zaventem
    B.5.3.3Post code1930
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032474074.584
    B.5.5Fax number00322309 64 06
    B.5.6E-mailnath.verbist@bgdo.org
    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 1 DB, 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 nab-paclitaxel (albumin bound)
    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
    locally advanced or metastatic pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    cancer of the pancreas that is extensive locally or at spread in distant organs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare quality of life scores and times to definitive deterioration of the QOL scores in patients receiving nab-paclitaxel + gemcitabine versus gemcitabine alone using the EORTC QLQ-C30 questionnaire.
    E.2.2Secondary objectives of the trial
    To evaluate in both treatment Arms:

    Safety and tolerability profile (NCI-CTCAE v. 4.0)
    Overall response and duration of response as assessed by imaging (RECIST 1.1) and tumour markers
    Disease control rates
    Progression free survival and overall survival
    Changes in serum CA 19-9 and CEA and composite index CA19-9xCEA
    Exploratory biomarker analyses by immunohistochemistry, proteomics, microarray and polymerase chain reaction (PCR) studies on tissue, blood and blood products and correlations with outcome.
    Exploratory hypoxia studies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/local regulations.
    2.Patient is at least 18 years of age.
    3.Unresectable locally advanced or metastatic pancreatic cancer.
    4.Histologically or cytologically confirmed adenocarcinoma of the pancreas. Islet cell neoplasms and neuroendocrine tumours are excluded..
    5.Evaluable or measurable disease, not in a previously irradiated area.
    6.Life expectancy of at least 12 weeks.
    7.WHO ECOG performance status ≤ 2
    8.Adequate organ function.
    9.Adequate bone marrow, hepatic and renal function.
    10.Acceptable coagulation determined on routine tests (e.g. prothrombin time, partial thromboplastin time, INR, etc, within +/- 15% of normal limits or as per clinical practice).
    11.No clinically significant abnormalities in urinalysis.
    12.Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
    E.4Principal exclusion criteria
    1.Prior chemotherapy, surgery or other investigational therapy for the treatment for metastatic disease. Adjuvant treatment with gemcitabine or 5-FU is allowed provided at least 6 months have elapsed since completion of the last dose.
    2.Major surgery within 4 weeks of the start of the study.
    3.Irradiation within 3 weeks prior to study entry.
    4.Brain metastasis (known or suspected).
    5.Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk including coronary stenting or myocardial infarction in the last year and psychiatric disorders.
    6.Known infection with HIV or active infection with hepatitis B or C.
    7.History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa, etc).
    8.History of interstitial lung disease.
    9.History of peripheral artery disease.
    10.Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
    11.Known allergy or any other adverse reaction to any of the drugs or to any related compound.
    12.Use of oral anticoagulants that interfere with the metabolic path of nab-Paclitaxel (cytochrome P450 isoenzymes CYP2C8 and CYP3A4) such as warfarin (Coumadin), rivaroxaban (Xarelto), etc, and the impossibility to switch anticoagulation treatment to low molecular weight heparin.
    13.Organ allografts requiring immunosuppressive therapy.
    14.Pregnancy or breast-feeding.
    15.Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The deterioration free rate at 3 months, comparatively in both treatment Arms is the study primary variable.
    The deterioration free survival rate at 3 months is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL scores at 3 months. The deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) between the score at baseline and any timepoint. The time interval will be calculated from the time of completion of the baseline QOL questionnaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    QOL questionnaires will be applied to patients every 4 weeks for a maximum of 12 months. The analysis of the primary (and secondary endpoints) will be performed at the end of the study.
    E.5.2Secondary end point(s)
    Descriptive safety; incidence of treatment-emergent toxicities in both Arms and incidence of dose modifications, interruptions and discontinuations.
    Dose density and dose intensity.
    Response and disease control rates - response evaluation will be performed every 8 weeks according to RECIST criteria (CT/MRI scan)
    Duration of response
    PFS
    OS
    Evolution of the levels of carbohydrate antigen 19 9 (CA19 9) on treatment (q 8 weeks) and composite index.
    Biomarkers that can be related with benefit to nab-paclitaxel: Potential SNPs , Circulating DNA, Circulating micro-RNA, Selected cytokines (ELISA), hENT1, SPARC, dCK and S100A2 expression (immunohistochemistry/qPCR), Hypoxia studies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuous for safety and dose intensity/density, q8weeks for tumour/response evaluations, continuous for survival, baseline for tissue collection, 3-4 timepoints for blood collection.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Comparison between arms (combination nab-paclitaxel+gemcitabine versus gemcitabine alone) only for Q
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison 2 arms (combi nab-paclitaxel+gemci vs gemci alone) only for QOL scores/main endpt
    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 concerned19
    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 and one year
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 state143
    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)
    Treatment after end of study = Not different from the expected normal treatment ((second line or best supportive care).

    Patients randomised to the monotherapy treatment (standard medication, no IMP) can switch to the combination regimen arm upon progression on monotherapy.
    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 Decision2014-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-15
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