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NDV-01 KIT in Participants With Non Muscle Invasive Bladder Cancer (NMIBC)
NCT06663137Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2024
- Primary completion
- Nov 2027
- Countries
- 1
- Sponsor
- Relmada Therapeutics, Inc.
- Modality
- Small Molecules
- Drugs
- NDV-01
- Conditions
- non-muscle-invasive bladder cancer (NMIBC)
01
Overview
Phase 2, open-label, single-arm trial of NDV-01 in non-muscle-invasive bladder cancer (NMIBC), sponsored by Relmada Therapeutics, Inc. Primary endpoints: Complete Response at 48 weeks and Adverse Events at 48 weeks. Started Aug 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
NDV01
Intravesical instillation of Carbopol Gel followed by NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg)
03
Who it enrols
Patients aged 18-80 with histologically confirmed high-grade NMIBC, ineligible for or electing not to undergo radical cystectomy, with ECOG status 0-2 and life expectancy >2 years.
04
Endpoints
Primary
Complete Response
Adverse Events
Secondary
Durability of Complete Response
Complete Response in Carcinoma In Situ
Event-Free Survival
Durability of Event-Free Survival
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