NDV01 intravesical controlled release formulation of gemcitabine and docetaxel

1 clinical trials involving this therapy/drug

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Descriptions are automatically translated with AI assistance. Always verify details in the original on ClinicalTrials.gov and consult your treating physician.

RecruitingPhase IIBladder cancer

A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC

NCT06663137ClinicalTrials.gov ↗

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.

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