Hearing Loss OtotoxicPhase 2NOTOXISNCT05628233
SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
A Phase 2 study testing SENS-401 (R-Azasetron Besylate) in people with Hearing Loss Ototoxic, run by Sensorion at 1 site in France.
Trial summary
This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss Ototoxic
- What is being tested?
- SENS-401 (R-Azasetron Besylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2022to 11 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of signing the ICF.
- Neoplastic subject that regardless of participation in this study is planned to be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m² per cycle and a cumulative dose of cisplatin of at least 210 mg/m².
Who cannot join
- 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.
- A congenital or hereditary disease known to decrease hearing function.
- Any medical history affecting the middle ear function such as chronic otitis, cholesteatoma, or tympanic membrane perforation.
- Any inner ear disease that is likely to decrease hearing function according to the Investigator's judgment (e.g, herpes zoster oticus; Meniere's disease; purulent labyrinthitis; vestibular schwannoma).
- Having a history of sudden sensory neural hearing loss.
- Having a fluctuating hearing loss (e.g, due to Meniere's disease, vestibular aqueduct syndrome, or autoimmune inner ear disease).
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- History of head trauma with hearing loss.
- History of meningitis.
- Having received concomitant treatment known or suspected to induce an ototoxicity within 6 months prior to Screening (i.e, aminoglycosides, loop diuretics, quinine) and any other treatments listed in Appendix 5. Previous treatment with a platinum treatment should be considered as an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Multicenter, Randomized, Controlled, Open Label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.
Read the detailed description
This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan. Cisplatin treatment per chemotherapy protocol must be given at a cumulative dose high enough to significantly increase the iatrogenic likelihood of ototoxicity (unit cisplatin dose of at least 70 mg/m2 and cumulative cisplatin dose of at least 210 mg/m²). If all the eligibility criteria are met, subjects will be randomized to one of two study arms as follows:
- Arm A (control arm): Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly the incidence and the time to onset of hearing impairment due to ototoxicity.
- Arm B: Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.
All subjects will be followed up to 12 weeks after the completion of the cisplatin therapy.
- Conditions
- Hearing Loss Ototoxic
- Being tested
- SENS-401 (R-Azasetron Besylate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENS-401 (R-Azasetron Besylate)Drug
Patients will receive SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (control arm) | No intervention | Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity. |
| Arm B (treatment arm) | Experimental | Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. Receives: Drug: SENS-401 (R-Azasetron Besylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 4 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject
Pure tone audiometry (PTA) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels measured in decibels (dB) and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition.
PTA assessments were conducted at Baseline (prior to the first dose of cisplatin), 4 weeks and 12 weeks after the completion of cisplatin treatment for all participants (Arms A and B).
The change in hearing threshold from baseline was evaluated at the average across three contiguous hearing frequencies (8-10-12.5 kHz) using PTA.
Measured: 4 weeks after the completion of cisplatin treatment
Secondary outcomes (1)
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 12 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject.
Pure tone audiometry (PTA) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels measured in decibels (dB) and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition.
PTA assessments were conducted at Baseline (prior to the first dose of cisplatin), 4 weeks and 12 weeks after the completion of cisplatin treatment for all participants (Arms A and B).
The change in hearing threshold from baseline was evaluated at the average across three contiguous hearing frequencies (8-10-12.5 kHz) using PTA.
Measured: 12 weeks after the completion of cisplatin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start30 Dec 2022
- Primary completion16 Apr 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss OtotoxicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensorion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628233
- Sponsor's protocol ID
- SENS-401-202
- Acronym
- NOTOXIS
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2022
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Randomized, Controlled, Open Label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease
- ClinicalTrials.gov ID
- NCT05628233
- Acronym / sponsor ID
- NOTOXIS / SENS-401-202
- Conditions
- Hearing Loss Ototoxic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SensorionIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.
Detailed description
This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan. Cisplatin treatment per chemotherapy protocol must be given at a cumulative dose high enough to significantly increase the iatrogenic likelihood of ototoxicity (unit cisplatin dose of at least 70 mg/m2 and cumulative cisplatin dose of at least 210 mg/m²). If all the eligibility criteria are met, subjects will be randomized to one of two study arms as follows:
- Arm A (control arm): Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly the incidence and the time to onset of hearing impairment due to ototoxicity.
- Arm B: Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity.
All subjects will be followed up to 12 weeks after the completion of the cisplatin therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (control arm) | No intervention | –Subjects receiving cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data, particularly on the incidence and the time to onset of hearing impairment due to ototoxicity. |
| Arm B (treatment arm) | Experimental | Drug: SENS-401 (R-Azasetron Besylate)Subjects receiving 43.5 mg of oral SENS-401 b.i.d for up to 23 weeks. This arm will provide data on the potential protective effects of SENS-401 on cisplatin induced ototoxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years at the time of signing the ICF.
- Neoplastic subject that regardless of participation in this study is planned to be treated with a chemotherapy that includes a dose of cisplatin of at least 70 mg/m² per cycle and a cumulative dose of cisplatin of at least 210 mg/m².
Key exclusion criteria (9 listed)
- 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.
- A congenital or hereditary disease known to decrease hearing function.
- Any medical history affecting the middle ear function such as chronic otitis, cholesteatoma, or tympanic membrane perforation.
- Any inner ear disease that is likely to decrease hearing function according to the Investigator's judgment (e.g, herpes zoster oticus; Meniere's disease; purulent labyrinthitis; vestibular schwannoma).
- Having a history of sudden sensory neural hearing loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENS-401 (R-Azasetron Besylate)Patients will receive SENS-401 ((R)-azasetron besylate) B.I.D. up to 23 weeks: 1 week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment (estimated to last up to 18 weeks) and 4 weeks after stopping chemotherapy. | Drug | Arm B (treatment arm) |
Primary outcome
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 4 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject
Time frame: 4 weeks after the completion of cisplatin treatment
Pure tone audiometry (PTA) is a behavioral, subjective hearing test used to assess an individual's hearing threshold levels measured in decibels (dB) and determine the degree of hearing loss. A decrease of hearing threshold is considered as an improvement and an increase as a deterioration of the audition. PTA assessments were conducted at Baseline (prior to the first dose of cisplatin), 4 weeks and 12 weeks after the completion of cisplatin treatment for all participants (Arms A and B). The change in hearing threshold from baseline was evaluated at the average across three contiguous hearing frequencies (8-10-12.5 kHz) using PTA.
1 secondary outcome
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 12 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject.
Time frame: 12 weeks after the completion of cisplatin treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SENS-401 (R-Azasetron Besylate) in people with Hearing Loss Ototoxic, run by Sensorion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SENS-401 Efficacy Assessment With Change From Baseline of the Average of the Hearing Threshold 4 Weeks After the Completion of Cisplatin Treatment in Each Eligible Ear of Each Subject (time frame: 4 weeks after the completion of cisplatin treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.