Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valrubicin · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| AD32 (valrubicin) | EXPERIMENTAL | 800mg, once weekly for 6 weeks |
| Name | Type | Description |
|---|---|---|
| Valrubicin, 800 mg | DRUG | Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications. |
Inclusion- 1. Patients must have pathologically-proven CIS with no evidence of muscle invasive disease. 2. Patients with concurrent Ta or T1 papillary tumors are eligible provided papillary tumor(s) are resected prior to study treatment. Cystoscopic evaluation and, if indicated, transurethral resec...
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Valrubicin is used for carcinoma in situ (CIS) of the bladder, specifically in patients who have failed or have recurrence following treatment with Bacillus Calmette-guerin (BCG). It is administered intravesically, meaning directly into the bladder, and is being studied as a treatment for this condition.
Valrubicin is a small molecule that targets cancer cells by intercalating into DNA and inhibiting topoisomerase II, which disrupts DNA replication and leads to cell death. This mechanism is particularly relevant for treating carcinoma in situ of the bladder, where the drug is delivered directly to the tumor site.
Valrubicin is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The company is conducting clinical research on this drug for the treatment of carcinoma in situ of the bladder, focusing on patients who have not responded to prior BCG therapy.
Valrubicin is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being evaluated for its efficacy and safety in treating carcinoma in situ of the bladder.
Valrubicin has one completed Phase 2 clinical trial, identified as NCT01316874. This trial enrolled 90 participants with carcinoma in situ of the bladder who had failed or experienced recurrence after BCG treatment. The study was conducted in the United States and included adults aged 18 years and older.
Yes, Valrubicin is also known as AD 32. The clinical trial NCT01316874, which studied intravesical AD 32 (Valrubicin) in patients with carcinoma in situ of the bladder, confirms that AD 32 is an alternative name for Valrubicin. This naming is used interchangeably in clinical research.