The experimental drug being investigated in this study is called rucaparib. Rucaparib is being developed by Clovis Oncology, Inc. (the Sponsor), a biopharmaceutical company with headquarters in the United States (US). Rucaparib (trade name: Rubraca) is a medicine that is approved in the European Union (EU) and the US for use in certain types of ovarian…
Acute unilateral vestibulopathy (AUV) (previously called acute vestibular neuritis) is the third most frequent cause of peripheral vestibular vertigo, after benign paroxysmal positional vertigo and Menires disease.The goal of this study is to look at the effects of a new drug (SENS-111) in controlling the acute vertigo and other symptoms related to AUV more…
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…
SY-1365 is an investigational drug that stops the function of a protein known as CDK7. Previous workhas shown that CDK7 is necessary for some cancers to grow. Therefore, SY-1365 could be used to slow down the growth of cancer. This research study is being done to understand the highest tolerated dose of SY-1365, and to assess the safety of SY-1365 in…
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
This is a Phase 1/2 multicenter study of VX15/2503 in pediatric patients and young adults with solid tumors which have come back or have not responded to standard therapy. The study treatment is considered experimental because VX15/2503 is not approved by the United States (US) Food and drug Administration (FDA) for treating pediatric patients and young…
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…
The study drug (TSR-042) in this study is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. The Study Drug is designed to help your immune system by attaching to a protein called PD-1 and stopping one of the signals that keeps your immune system from recognizing the cancer. This may help your immune system…
The objective of the study is to evaluate the safety and effectiveness of the TULA System for the placement of tympanostomy tubes (ear tubes) under local anesthesia in an office/clinic setting.