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

NCT05628233 | Completed Phase 2 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

  Change from baseline of the average of the hearing threshold of 3 contiguous hearing frequencies assessed with a 0.5-12.5 kHz audiogram 4 weeks after the completion of the last cisplatin treatment in each ear of each subject.

  23 weeks

Secondary Outcomes (7)

• SENS-401 efficacy assessment with change from baseline of the average of the hearing threshold 12 weeks after the completion of cisplatin treatment.

  31 weeks

• SENS-401 efficacy assessment with change from baseline in the distribution of hearing loss severity 4 weeks after the completion of cisplatin treatment

  23 weeks

• SENS-401 efficacy assessment with change from baseline in the distribution of hearing 12 weeks after the completion of cisplatin treatment

  31 weeks

• SENS-401 efficacy assessment with change from baseline in speech discrimination test score 4 weeks after the completion of cisplatin treatment.

  23 weeks

• SENS-401 efficacy assessment with change from baseline in speech discrimination test score 12 weeks after the completion of cisplatin treatment

  31 weeks

Study Arms (2)

Study Arm A (control arm)

NO INTERVENTION

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.

Study 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.

Study 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

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 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)