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Tests treatment safety and results for Non Muscle Invasive Bladder Cancer
Official title Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC
ClinicalTrials.gov ID: NCT06663137
What this study is testing
What is NDV01 intravesical controlled release formulation of gemcitabine and docetaxel?
NDV01 intravesical controlled release formulation of gemcitabine and docetaxel is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for non muscle invasive bladder cancer.
Also referred to as Gemcitabine and docetaxel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people may participate in the study if they meet all the following 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 evaluation...
- Participants must be ineligible for or have elected not to undergo radical cystectomy.
You likely can't join if
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic...
- Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample.
- Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like...
- Current systemic therapy for bladder cancer.
- Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).
- Clinically significant and unexplained elevated liver or renal function tests.
See the full eligibility criteria
- people may participate in the study if they meet all the following 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 evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the...
- Participants must be ineligible for or have elected not to undergo radical cystectomy.
- Available for the whole duration of the study.
- Life expectancy \>2 years, in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) status 2 or less.
- Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor...
- Patients with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) \< 10 ng/dL, Gleason score 6 and clinical stage tumor-1 (cT1) are permitted to be in the study...
- Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a...
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic disease are (but not limited to):
- Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample.
- Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion..
- Current systemic therapy for bladder cancer.
- Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).
- Clinically significant and unexplained elevated liver or renal function tests.
- Women who are pregnant or lactating or refuse to commit to using contraception anytime during the study.
- Any other significant disease or other clinical findings which in the investigator's opinion would prevent study entry.
- History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24...
The study team makes the final eligibility decision.
Where it's taking place
- Raanana, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Raanana, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.