A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-80 lat
- •Potwierdzony rozpoznaniem wysokozaawansowanego raka pęcherza niezatarczającego mięśnie
- •Pacjent nie chce lub nie może przejść operacji usunięcia pęcherza
- •Dobry stan ogólny zdrowia (zdolność do wykonywania codziennych czynności)
- •Oczekiwana długość życia ponad 2 lata
- •Brak raka w górnych drogach moczowych
- •Kobieta w wieku rozrodczym musi stosować skuteczną antykoncepcję
- •Dostępny na czas trwania całego badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- September 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Relmada Site
Raanana, Israel
Trial contact
Scott White
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/3/2026.
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