Multicenter randomized phase 1b trial of DB-020 intratympanic injection to reduce high-dose cisplatin ototoxicity

DB-020 is a formulation of thiosulfate for intratympanic (IT) injection to reduce ototoxicity in patients receiving high-dose cisplatin chemotherapy. A randomized phase 1b trial, at five centers in Australia and the USA, evaluated DB-020. Patients received IT DB-020 (at a dose level of 12% or 25%) in one ear and placebo in the other ear, every 3 or 4 weeks, within 3 hours before receiving cisplatin. Ear pain of short duration was common after IT injections, but there were no serious adverse events. Ototoxicity after cisplatin administration was significantly more common in placebo-treated ears than in DB-020-treated ears (p=0.0027). The authors conclude that DB-020 IT injections were tolerated and showed meaningful reductions in cisplatin ototoxicity.