A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence
Phase of Trial: Phase II
Latest Information Update: 27 Dec 2018
At a glance
- Drugs Mitomycin (Primary)
- Indications Bladder cancer; Urogenital cancer
- Focus Therapeutic Use
- Sponsors UroGen Pharma
- 14 Aug 2018 Status changed from not yet recruiting to recruiting, according to an UroGen Pharma media release.
- 11 Jul 2018 According to an UroGen Pharma media release, the company has submitted an IND application for UGN-102 (VesiGel, mitomycin gel for intravesical instillation) for the treatment of patients with low-grade non-muscle invasive bladder cancer (LG NMIBC) to the US FDA and if accepted, the company expects to begin this trial in Q3 2018.
- 24 Jun 2018 Status changed from planning to not yet recruiting.