RecruitMe Clinical Trial

OTO-104-201607: A multicenter, randomized, 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
A study to Assess Safety and Effectiveness of Study Drug OTO-104 in Patients at Risk of Hearing Loss From Cisplatin Chemotherapy
Sponsor:Otonomy
Enrolling:Male and Female Patients
Age Range:Between 1 and 21 years old
IRB Number:AAAR0729
U.S. Government ID:NCT02997189
Contact: Jessica Campbell: 212-305-2298 / jc4353@cumc.columbia.edu
Additional Study Information:

Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an active ingredient, called dexamethasone that has been shown to protect against hearing loss associated with cisplatin therapy. If you qualify to participate in this study, you will receive OTO-104 in the same ear before each of your first few cisplatin treatment cycles, for a maximum of 3 administrations. You could receive OTO-104 fewer than 3 times if you receive less than 3 cisplatin treatment cycles.

This study is closed
Investigator
Alice Lee, MD
You may be eligible for this study

Place Holder




Who Can I Contact?
For more information, please contact:
Jessica Campbell
Email: jc4353@cumc.columbia.edu
Phone: 212-305-2298