SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

NCT05628233 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SENS-401-202
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 the chemotherapy protocol plan.

Conditions

Hearing Loss Ototoxic

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 weeks after the completion of cisplatin treatment

Study Arms (2)

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.

Drug: SENS-401 (R-Azasetron Besylate)

Interventions

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.

Arm B (treatment arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• History of head trauma with hearing loss.
• History of meningitis.

Sponsors & Collaborators

• Sensorion: lead

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Interventions

SENS-401

Results Point of Contact

• Title: Head of Medical
• Organization: Sensorion

contact@sensorion-pharma.com

+33686831180

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: December 30, 2022
• Primary Completion: April 16, 2025
• Study Completion: June 11, 2025
• Last Updated: July 2, 2026
• Results First Posted: July 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)