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    Summary
    EudraCT Number:2017-002320-25
    Sponsor's Protocol Code Number:UC_0106/1712
    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:2018-06-07
    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 number2017-002320-25
    A.3Full title of the trial
    Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: A phase II randomized study by the UNICANCER with cooperation of AFSOS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    RILUZOX-01
    A.4.1Sponsor's protocol code numberUC_0106/1712
    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 SponsorUNICANCER
    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 supportProgramme Hospitalier de Recherche Clinique
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33171 93 67 07
    B.5.5Fax number33185 34 33 80
    B.5.6E-mailv-plence@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 RILUTEK
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    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 Coated tablet
    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 INNRILUZOLE
    D.3.9.1CAS number 1744-22-5
    D.3.9.4EV Substance CodeSUB10319MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colorectal cancer stage II/III with adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4)
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    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
    Assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy in stage II/III CRC patients
    E.2.2Secondary objectives of the trial
    - To assess the effect of riluzole on
    •Neuropathic pain,
    •Incidence of neuropathy,
    •Impact on Health-related quality of life (HRQoL),
    •Disease Free Survival,
    •Overall Survival
    •Time to Treatment Failure.
    •Time to HRQoL score deterioration
    •Toxicity (NCI-CTC V5.0)
    - To quantify and compare the chemotherapy dose reductions, cumulative doses, and study exit rates in the study arms.
    - To correlate glutamate serum levels with colorectal cancer TNM scores and symptoms of OIPN
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged ≥ 18 years old,
    2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4) for stage II/III colorectal cancer,
    3. Histological or cytological confirmation of a colorectal cancer,
    4. PS (ECOG) ≤ 2,
    5. Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome); ASAT and ALAT ≤3 x ULN, and GGT≤3 x ULN.
    6. Normal renal function: creatinine clearance (CL) >40 mL/min or calculated creatinine clearance CL>40 mL/min (Cockcroft-Gault formula),
    7. Normal cardiac function: ECG
    8. Patients affiliated to the French national or European health insurance,
    9. Patient must have signed a written informed consent form prior to any study specific procedures,
    10. French language comprehension,
    11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    E.4Principal exclusion criteria
    1. Metastatic cancer,
    2. Diagnosis of neuropathy,
    3. EORTC QLQ-CIPN20 sensory score > 6,
    4. Previous neurotoxic chemotherapy treatment,
    5. Patients with chronic obstructive pulmonary disease,
    6. ALT / AST elevated more than 3 times the normal value,
    7. Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients,
    8. Dependence on alcohol and / or drugs,
    9. Psychotic disorders
    10. Women pregnant or breastfeeding,
    11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
    E.5 End points
    E.5.1Primary end point(s)
    For the primary endpoint of the study, only the sensory scale scores will be assessed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 cycles of chemotherapy (V2 visit)
    E.5.2Secondary end point(s)
    - Sensory, motor and autonomic scales from QLQ-CIPN20 questionnaire & longitudinal analysis,
    - Grade of chemotherapy-induced peripheral neuropathy (NCI-CTCAE v5.0),
    - Score of pain by the BPI SF questionnaire, screening of neuropathic pain by the DN4 interview questionnaire and characterization of neuropathic pain by NPSI questionnaire,
    - Health-related quality of life (HRQoL) by the QLQ-C30 questionnaire (EORTC) & longitudinal analysis,
    - Disease Free Survival, defined as the interval between the date of randomization and the date of cancer relapse (local, regional, metastases, second cancer) or death from any cause, whichever occurs first,
    - Overall survival, defined as the interval between the date of randomization and the date of death from any cause,
    - Time to treatment failure, defined as the interval between randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death,
    - Time to HRQoL score deterioration, defined as the interval between randomization and deterioration ≥ 5 points in the HRQoL score as compared to baseline score or death (all causes),
    - Quantification of chemotherapy dose reductions following a chemotherapy-induced neuropathy,
    - Assessment of adverse events (excluding chemotherapy-induced neuropathies) associated with cancer, anticancer chemotherapy and study treatment (NCI-CTCAE v5.0),
    - Cumulative dose of anticancer received by the patients,
    - Assessment of glutamate serum level for correlation with CRC TNM score and neuropathy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    _
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Double blind
    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 concerned18
    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
    LVLS
    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 months42
    E.8.9.1In the Member State concerned days15
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state210
    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 Decision2018-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-03
    P. End of Trial
    P.End of Trial StatusOngoing
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