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    Summary
    EudraCT Number:2021-002705-10
    Sponsor's Protocol Code Number:SENS-401-202
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-06
    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 number2021-002705-10
    A.3Full title of the trial
    An Exploratory, Phase IIa, Multicenter, Randomized, Controlled, Open label Study to Evaluate the Efficacy of SENS-401 to Prevent or Treat the Ototoxicity due to Cisplatin in Adult Subjects with a Neoplastic Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SENS-401 to Prevent or Treat the Ototoxicity due to Cisplatin in Adult Subjects with a Neoplastic Disease
    A.4.1Sponsor's protocol code numberSENS-401-202
    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 SponsorSENSORION PHARMA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSensorion Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSensorion Pharma
    B.5.2Functional name of contact pointValérie SALENTEY
    B.5.3 Address:
    B.5.3.1Street Address375, Rue du Professeur Blayac
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34080
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 6 30 28 38 24
    B.5.6E-mailvalerie.salentey@sensorion-pharma.com
    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.3.2Product code SENS-401
    D.3.4Pharmaceutical form 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 INNARAZASETRON
    D.3.9.2Current sponsor codeSENS-401
    D.3.9.3Other descriptive nameR-AZASETRON BESILATE
    D.3.9.4EV Substance CodeSUB192414
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number43.5
    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
    Cisplatin-induced hearing loss
    E.1.1.1Medical condition in easily understood language
    Cisplatin is a neoplastic agent cause hearing loss
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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 assess the efficacy of SENS-401 (43.5 mg given orally twice daily [BID] for 13 weeks) versus control to prevent or treat ototoxicity in adult subjects with a neoplastic disease and under cisplatin-based chemotherapy treatment.
    E.2.2Secondary objectives of the trial
    * Exploratory
    To explore the correlation between biomarkers already pre-identified (eg, prestin) or that will be identified in the future with clinical features of interest (like prediction of ototoxicity).

    * To evaluate the performance of an application (headphone and tablet) to evaluate hearing level in a range of frequencies.

    * Safety
    To assess the safety of SENS-401 (43.5 mg given orally BID for 13 weeks) in adult subjects with a neoplastic disease and under cisplatin-based chemotherapy treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years at the time of signing the ICF.
    2. Capable of giving signed informed consent as described in Appendix 2Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    3. A female subject is eligible to participate if she is not pregnant, not
    breastfeeding, and ≥ 1 of the following conditions applies:
    - Not a woman of childbearing potential (WOCBP)
    - A WOCBP who agrees to follow the contraceptive guidance at least
    until the randomization if she is allocated to the Arm A and for the Arms B and C, for ≥ 30 days after the last dose of investigational medicinal product (IMP), ie, SENS-401.

    A male subject must agree to use contraception and refrain from donating sperm as detailed in Appendix 6 of this protocol at least until the randomization if he is allocated to the Arm A and for
    the Arms B and C for ≥ 30 days after the last dose of SENS-401.

    4. Neoplastic subjects that regardless of participation in this study are planned to be treated with a chemotherapy that includes a cumulative cisplatin dose of at least 200 mg/m2.
    5. Subjects with PTA threshold ≤ 30 dB at 500 Hz, 40 dB for 1-2-4 kHz, and 60 dB for 8 kHz and above.
    6. In the opinion of the Investigator, minimum life expectancy of ≥ 6 months.
    7. Vaccinated against coronavirus disease 2019 (COVID-19) or previously contracted the disease and recovered.
    E.4Principal exclusion criteria
    1. Any condition or past medical history that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
    2. Subject is the Investigator or anyone from his/her team directly involved in the conduct of the protocol.
    3. A subject not willing to participate to the 2 stages of the study in case of Arm C allocation.
    4. Mentally unable to understand the nature, objectives, and possible consequences of the study or refusing its constraints.
    5. A congenital or hereditary disease known to decrease hearing function (eg, Otoferlin [OTOF] related deafness).
    6. Any medical history affecting the middle ear function such as chronic otitis, cholesteatoma, or tympanic membrane perforation.
    7. Any inner ear disease that is likely to decrease hearing function according to the Investigator’s judgment (eg, herpes zoster oticus; Meniere’s disease; purulent labyrinthitis; vestibular schwannoma).
    8. Having history of sudden sensory neural hearing loss.
    9. Having a fluctuating hearing loss (eg, due to Meniere’s disease, vestibular aqueduct syndrome, or autoimmune inner ear disease).
    10. History of head trauma with hearing loss.
    11. History of meningitis.
    12. For a subject expected to receive radiotherapy during the course of the study, anticipated risk to expose the auditory system (ie, inner ear within the expected irradiation zone).
    13. History of significant arrhythmia or conditions known to increase proarrhythmic risk (eg, congestive heart failure, long QT syndrome, hypokalemia).
    14. Significant clinically relevant electrocardiogram (ECG) abnormality that, in the opinion of the Investigator, precludes study eligibility.
    15. Significant abnormal laboratory result, physical examination, vital signs, or ear-nose-throat (ENT) evaluation (otoscopy and immittance audiometry), in the opinion of the Investigator.
    16. Neurological disorder including stroke, demyelinating disease, or brain stem or cerebellar dysfunction.
    17. Moderate to severe renal impairment defined by a creatinine clearance ≤ 60 mL/minute (calculated with the Cockcroft-Gault formula for subjects < 65 years old and with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation or
    with the Modification of Diet in Renal Disease (MDRD) equation for subjects ≥ 65 years old; see Appendix 3).
    18. Receiving statins at Screening.
    19. Receipt of concomitant treatment known or suspected to induce an ototoxicity within 6 months prior to Screening (ie, minoglycosides, loop diuretics, quinine) and any other treatments listed in Appendix 5.
    20. Treatment with any investigational agent within 4 weeks prior to Screening or 5 half-lives of the investigational drug (whichever is longer).
    21. Known or suspected ongoing active infection of human immunodeficiency virus (HIV), or COVID-19.
    22. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of more than Grade 1 ototoxic ears defined as hearing loss from baseline ≥ 15 dB above 1 kHz on 2 contiguous frequencies (Common Terminology Criteria for Adverse Events [CTCAE], Version 5.0) as assessed by pure tone audiometry (PTA) over a period of 9 months from the start of the cisplatin-based chemotherapy treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From day -2 to -28 (screening period)
    Every week for 9 Month (Through out study)
    E.5.2Secondary end point(s)
    - Proportion of more than Grade 2 ototoxic ears defined as hearing loss from baseline ≥ 25 dB above 1 kHz on 2 contiguous frequencies (CTCAE V5.0) as assessed by PTA over a period of 9 months from
    the start of the cisplatin-based chemotherapy treatment.
    - Proportion of more than Grade 3 ototoxic ears defined as hearing loss from baseline ≥ 25 dB above 1 kHz on 3 contiguous frequencies (CTCAE V5.0) as assessed by pure‑tone audiometry [PTA]) over a period of 9 months from the start of the cisplatin-based chemotherapy treatment.

    - Exploratory endpoint:
    Serum/plasma concentrations of selected biomarkers
    at baseline (ie., Visit 2 prior to cisplatin administration) and at Visits 2 (just after rehydration post cisplatin treatment), 3, 4 and 11.

    - Sensitivity and specificity of hearing thresholds measured by auto-testing in each frequency tested in comparison with PTA values.

    - Safety
    Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    From day -2 to -28 (screening period)
    Every week for 9 Month (Through out 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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Controlled group subjects will not exposed to SENS-401
    E.8.2.4Number of treatment arms in the trial3
    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 concerned8
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    France
    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
    Date of the last visit of the last subject 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 months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 60
    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)
    The Sponsor will not provide any additional care to subjects after they leave the study because such care should not differ from what is normally expected for neoplastic subjects with chemotherapy-induced ototoxicity.
    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 Decision2022-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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