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    Summary
    EudraCT Number:2017-002037-31
    Sponsor's Protocol Code Number:2017/15
    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:2019-10-11
    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 number2017-002037-31
    A.3Full title of the trial
    Study of the impact of DPD activity on the efficacy of capecitabine
    Etude de l’impact de l’activité DPD sur l’efficacité de la capécitabine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the impact of DPD activity on the efficacy of capecitabine
    Etude de l’impact de l’activité DPD sur l’efficacité de la capécitabine
    A.3.2Name or abbreviated title of the trial where available
    DPD MAX
    A.4.1Sponsor's protocol code number2017/15
    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 SponsorCentre Antoine-LACASSAGNE
    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 supportCentre Antoine-LACASSAGNE
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCantre Antoine-LACASSAGNE
    B.5.2Functional name of contact pointMaeva MAURIN-GODEMERT
    B.5.3 Address:
    B.5.3.1Street Address33 avenue de Valombrose
    B.5.3.2Town/ cityNICE
    B.5.3.4CountryFrance
    B.5.4Telephone number+330492031132
    B.5.5Fax number+330492031030
    B.5.6E-mailDRCI-Promotion@nice.unicancer.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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Metastatic HER2-negative breast cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer with negative HER2-Receptors
    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 10027475
    E.1.2Term Metastatic breast cancer
    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 analyze the influence of the DPD phenotype (DPD enzymatic activity in lymphoctye), on the objective response after 6 months of capecitabine given in monotherapy in patients with metastatic breast cancer.
    E.2.2Secondary objectives of the trial
    - To analyze the influence of the DPD phenotype (uracilemia) on the objective response to treatment,
    - To compare DPD enzymatic activity in lymphocyte and uracilemia.
    - To define the threshold of DPD with risk of loss of therapeutic efficacy
    - To analyze the influence of DPD phenotype on overall survival
    - To analyze the influence of DPD phenotype on progression free survival
    - To analyze the influence of DPD phenotype on toxicities occurrences
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age over 18,
    PS 0 to 2,
    Patients with metastatic HER2 negative breast cancer,
    Patient eligible to a treatment with capecitabine in monotherapy at 2000 mg/m2/D, 14 days every 21 days,
    Patient with a Uracilemia dosage performed following the French health recommendation
    Patients with at least one assessable lesion according to the RECIST criteria 1.1.
    Patients who have been informed and signed the informed consents (including the specific consent for DPYD genotyping),
    Patients with social coverage.
    E.4Principal exclusion criteria
    PS> 2,
    Contraindication to Capecitabine treatment in monotherapy at 2000 mg/m2/D, 14 days every 21 days,
    Presence of known symptomatic cerebral or leptomeningeal metastases treated or uncontrolled (unstable corticosteroid requirements) and / or not clinically stable within 3 months before inclusion,
    History of cancer, with the exception of cancers in complete remission for more than 5 years, completely resected cutaneous basal cell carcinomas, in situ carcinomas or In situ cervical epithelioma treated,
    Vulnerable people as defined in Article L1121-5 to -8
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the objective response to 6 months of measured treatment according to the RECIST 1.1 scale. The objective answer is defined as
    complete + partial response against stabilization + progression.
    This analysis will compare the objective response rate between patients with proficient DPD phenotype, measured by lymphocyte DPD activity (>3rd quartile, 25% of patients) and non-deficient DPD patients (phenotype between 13th and 75th percentiles).
    E.5.1.1Timepoint(s) of evaluation of this end point
    42 months (inclusion periode of 36 months + 6 months of treatment)
    E.5.2Secondary end point(s)
    To compare the objective response rate (measured using the RECIST 1.1 scale) between patients with DPD proficient phenotype measured by the Uracilemia (< at the 1st quartile, ie 25% of patients) and patients without DPD deficiency (Uracilemia>at the 1st quartile )
    The thresholds for high lymphocyte DPD activity associated with loss of therapeutic efficacy will be define by maximizing the sensibility of a predictive model for lack of response to treatment by capecitabine
    The correlation between the lymphocyte DPD activity and uracilemia will be assess with the Pearson correlation coefficient
    The overall survival will be define as the time between the date of inclusion and the date of death or the date of last news for those still alive at the end of the follow-up.
    The progression free survival will be define as the time between the date of inclusion and the date of death or progression or the date of last news for those still alive and progression free at the end of the follow-up.
    Toxicity will be evaluate using the CTCAE v5.0


    - The overall survival at 5 years after the beginning of the treatment calculated between the date of inclusion and the date of breaking news at age 5 or death,
    - The 2-year progression-free survival calculated between the date of inclusion and the date of progression (defined according to RECIST v 1.1 criteria) or death or the date of the latest news for patients who have not progressed after 2 years,
    - The toxicity assessed using the Common Terminology Criteria for Adverse Events v4.03.
    - The concordance and correlation between these 4 markers will be compared in terms of sensitivity and specificity using ROC curves, correlation coefficient of Spearman and the Kappa concordance coefficient.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pronostic
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned5
    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
    The end of study is defined as the end of study declaration date.
    The study will be declared complete to the Competent Authorities, six months after the date of the last follow-up of patients included in the study.
    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 months60
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state155
    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)
    care after the subject has ended the participation in the trial is not different from the expected normal treatment of that 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 Decision2019-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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