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01
Overview
Phase 2, open-label trial of NanoDoce in bladder cancer (2 arms), sponsored by NanOlogy. Primary endpoint: Incidence of Treatment Emergent Adverse Events at Day 45. Started Apr 2019; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
NMIBC
NanoDoce injection + instillation + Induction/Maintenance instillations
MIBC
NanoDoce injection + instillation + Standard of Care
03
Who it enrols
Adults with confirmed High-risk NMIBC or MIBC, ECOG 0-2, adequate organ function. Excludes metastatic disease, recent intravesical therapy, and resection area > 8cm2.
04
Endpoints
Primary
Incidence of Treatment Emergent Adverse Events
Secondary
Recurrence Free Survival
Disease Progression
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