drugset / Trial / NCT00782587

Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer

NCT00782587

Phase 1 Completed 14 enrolled Halozyme Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to test the safety and tolerability of an experimental drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial bladder cancer when instilled intravesically immediately after TURBT (transurethral resection of bladder tumor).

Timeline

Start
2008-10
Primary completion
2009-03
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 40 mg Intravenous
Subject rHuPH20 Protein / enzyme biologic 800000 iu Intravenous