Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NDV-01 (sustained-release gemcitabine-docetaxel)
NDV-01 · 1 trial · 5 indications
Time from randomization to either time of the first recurrence or progression, or death due to any cause, whichever occurs first. It is hypothesized that sustained local delivery of GEM and DOCE (via NDV-01) in participants with IR-NMIBC will result in longer DFS than achieved with observation after TURBT. Under the exponential distribution assumption for DFS, this translates into testing the statistical hypothesis that the hazard ratio is significantly less than 1.0. Primary endpoint will be tested using a one-sided 2.5% level of significance.
Percentage of participants with CR at anytime based on cystoscopy, urine cytology, and biopsies. Protocol-driven mapping biopsies (as assessed by central pathology) will be performed at 12 months
| Arm | Type | Description |
|---|---|---|
| Intermediate Risk NMIBC, NDV-01 Treatment Group | EXPERIMENTAL | NDV-01 (sustained-release gemcitabine-docetaxel) |
| Intermediate Risk NMIBC, Observation Group | NO_INTERVENTION | Surveillance with Cystoscopy, Urine Cytology, and Biopsy (if indicated) |
| BCG-Unresponsive High-Risk NMIBC, NDV-01 Treatment Group | EXPERIMENTAL | NDV-01 (sustained-release gemcitabine-docetaxel) |
| Name | Type | Description |
|---|---|---|
| NDV-01 (sustained-release gemcitabine-docetaxel) | DRUG | NDV-01 (sustained-release gemcitabine-docetaxel) |
Cohort 1 Inclusion Criteria: 1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent. 2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR N...
NDV-01 is an investigational small molecule being developed for bladder cancer, specifically non-muscle invasive bladder cancer, a form of urothelial or transitional cell carcinoma. It is a sustained-release formulation of gemcitabine and docetaxel, designed for intravesical delivery to treat the disease.
NDV-01 contains two chemotherapy agents, gemcitabine and docetaxel, which target rapidly dividing cancer cells. Gemcitabine is a nucleoside analog that inhibits DNA synthesis, while docetaxel stabilizes microtubules, disrupting cell division. The sustained-release formulation is intended to maintain drug exposure within the bladder.
NDV-01 is being developed by Relmada Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RLMD. The company is advancing the drug through clinical trials for the treatment of non-muscle invasive bladder cancer.
NDV-01 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is designed to evaluate its efficacy and safety in participants with non-muscle invasive bladder cancer.
NDV-01 is being studied in a Phase 3 clinical trial registered as NCT07464145, titled 'A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer.' The trial is not yet recruiting and aims to enroll 393 participants.
Yes, NDV-01 is also known as sustained-release gemcitabine-docetaxel. This name reflects its formulation, which combines the two chemotherapy drugs gemcitabine and docetaxel in a sustained-release form for the treatment of non-muscle invasive bladder cancer.