Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss

Summary

This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.

Timeline

Start

2016-11-15

Primary completion

2017-09-26

Completion

2017-09-26

Outcome

Outcome not reported

Stopped: “Negative Efficacy Results from the recently completed Phase 3 study 104-201506”

Publications

• Background Fernandez R, Harrop-Jones A, Wang X, Dellamary L, LeBel C, Piu F. The Sustained-Exposure Dexamethasone Formulation OTO-104 Offers Effective Protection against Cisplatin-Induced Hearing Loss. Audiol Neurootol. 2016;21(1):22-9. doi: 10.1159/000441833. Epub 2016 Jan 21.

Drugs

Indications