Clinical Trial: Safety and Clinical Activity of CAVATAK™ Alone or With Low Dose Mitomycin C in Non-muscle Invasive Bladder Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Study to Evaluate the Safety and Clinical Activity of Intravesicular CAVATAK™ (Coxsackievirus A21, CVA21) Alone and in Sequential Combination With Low Dose

Brief Summary: The study will consist of 2 sequential parts. Part A is a study of the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B will evaluate the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.

Detailed Summary:
Sponsor: Viralytics

Current Primary Outcome: Safety and tolerability of CAVATAK following intravesical instillation as assessed by incidence of dose-limiting toxicities (DLT). [ Time Frame: 8 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Viralytics

Dates:
Date Received: December 7, 2014
Date Started: December 2014
Date Completion:
Last Updated: May 9, 2017
Last Verified: May 2017