Condition: Non Muscle Invasive Bladder Cancer · Sponsor: Relmada Therapeutics, Inc.
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.
This description comes directly from the study's public registry record.
Paul Greene · +15129691739 · pgreene@relmada.com
Scott White · +16464285264 · swhite@relmada.com
Always discuss trial participation with your own doctor first.
| Relmada Site | Raanana, Israel | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06663137