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

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.

Trial Details

NCT ID
NCT06663137
Phase
PHASE2
Sponsor
Relmada Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
Locations (sample)
  • Raanana, Israel|32.1836,34.87386

Key Eligibility Criteria

  • Aged 18 - 80 years old
  • Able to give informed consent
  • Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluatio…
  • Participants must be ineligible for or have elected not to undergo radical cystectomy.

For full eligibility, visit ClinicalTrials.gov.

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