Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of
intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with
non-muscle invasive bladder cancer (NMIBC). All participants will receive an induction course
of gemcitabine/docetaxel instillations followed by maintenance instillations if initial
efficacy is seen. In addition to providing initial efficacy data, this study will provide
safety and long-term efficacy data on the combination regimen studied. A tolerable safety
profile and demonstrated efficacy would support a potential, randomized phase 3 trial
comparing the experimental combination therapy and standard of care intravesical BCG therapy.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins