Trials / Withdrawn
WithdrawnNCT07342517
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Relmada Therapeutics, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
Detailed description
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy. Participants will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through 3 years, if there is no disease recurrence. Participants will received an induction course of NDV-01 (6-bi-weekly intravesical instillations). Those who achieve a complete response (CR) at 3 months will be eligible for monthly maintenance instillations through year 3. Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization or until disease recurrence.
Conditions
- Bladder (Urothelial, Transitional Cell) Cancer
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
- Urologic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NDV-01 (sustained-release gemcitabine-docetaxel) | Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel) |
Timeline
- Start date
- 2026-06-30
- Primary completion
- 2027-06-30
- Completion
- 2028-06-30
- First posted
- 2026-01-15
- Last updated
- 2026-03-17
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07342517. Inclusion in this directory is not an endorsement.