Actively Recruiting
Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC
Led by Relmada Therapeutics, Inc. · Updated on 2025-06-13
70
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years old
- Able to give informed consent
- Histologically confirmed high-grade non-muscle invasive bladder cancer
- Ineligible for or declined radical cystectomy
- Available for the entire study duration
- Life expectancy greater than 2 years as judged by investigator
- Eastern Cooperative Oncology Group (ECOG) status of 2 or less
- No upper tract urothelial carcinoma or urothelial carcinoma in prostatic urethra
- Patients with low-risk prostate cancer on active surveillance may participate at investigator discretion
- Women of childbearing potential must use effective birth control during therapy and for 1 month after last treatment with negative pregnancy test; others must be postmenopausal or surgically sterile
You will not qualify if you...
- Evidence of muscle invasive or metastatic bladder cancer
- Presence of lymphovascular invasion or micropapillary disease in biopsy
- T1 disease with hydronephrosis unless scheduled for treatment
- Current systemic therapy for bladder cancer
- Symptomatic urinary tract infection or bacterial cystitis (until treated)
- Clinically significant unexplained elevated liver or kidney function tests
- Pregnant or lactating women or women refusing contraception
- Any significant disease or condition preventing study entry
- History of other malignancies within past 5 years except certain skin cancers and low-stage upper tract urothelial carcinoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Relmada Site
Raanana, Israel, 4363007
Actively Recruiting
Research Team
P
Paul Greene
CONTACT
S
Scott White
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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