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
Sponsor: |
Otonomy |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR0729 |
U.S. Govt. ID: |
NCT02997189 |
Contact: |
Jessica Campbell: 212-305-2298 / jc4353@cumc.columbia.edu |
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
Are you diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors? |
Yes |
No |
Are you or is your child between the age of 6 months to 21 years? |
Yes |
No |