A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
brief 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.
detailed description
Eligible patients who sign informed consent will receive intravesical treatment with NDV01 KIT, consisting of a sequential instillation of Carbopol Gel followed by NDV01 solution using a 14F urethral catheter. The treatment phase includes six instillations on Days 1, 14, 28, 42, 56, and 70. Primary Disease Evaluation (PDE) will be conducted on Day 100 (±3). Patients achieving a complete response may continue into a maintenance phase with monthly instillations through Month 12.
Maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340.
The Primary Disease Evaluation (PDE) will be performed on Study Day 100±3.
A subset of patients will participate in a PK sub-study involving up to 15 blood draws to assess systemic levels of gemcitabine and docetaxel during the first treatment cycle.
Primary Objectives:
Assess safety of NDV01 KIT through the study period. Evaluate the complete response (CR) rate in patients with high-grade NMIBC.
Secondary Objectives:
Assess the durability of CR. Evaluate event-free survival (defined as high-grade recurrence-free survival). Assess the durability of event-free survival. Determine incidence and time to cystectomy. Determine overall survival. Monitor response durability through long-term follow-up.
Exploratory Objective:
Evaluate pharmacokinetic parameters of NDV01 KIT in a subset of patients during the initial treatment phase.
A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule.
official title
A Single-Center, Open Label, Single Arm Study, to Evaluate the Safety and Efficacy of NDV-01 KIT in Participants With Non Muscle Invasive Bladder Cancer (NMIBC)