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Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC

NCT06663137 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Non Muscle Invasive Bladder Cancer

Interventions

DRUG

NDV01 intravesical controlled release formulation of gemcitabine and docetaxel

NDV01 is administered intravesically using a catheter.

Sponsors & Collaborators

  • Relmada Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Boris Chertin · Head of Urology Dep Share Tzedek Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06663137 on ClinicalTrials.gov