drugset / Trial / NCT07313891
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2029-09-01
- Completion
- 2029-11-01
Publications
- Results Tan WS, McElree IM, Davaro F, Steinberg RL, Bree K, Navai N, Dinney CP, O'Donnell MA, Li R, Kamat AM, Packiam VT. Sequential Intravesical Gemcitabine and Docetaxel is an Alternative to Bacillus Calmette-Guerin for the Treatment of Intermediate-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2023 Oct;6(5):531-534. doi: 10.1016/j.euo.2023.06.011. Epub 2023 Jul 18.
- Results Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | — | Intravenous |
| Subject | Gemcitabine | Small molecule | — | Intravenous |