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padeliporfin VTP · 1 trial · 1 indication
Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response. · Complete Response will be defined as absence of disease based on: * absence of visual tumor on endoscopy * no evidence of tumor on biopsy (if feasible) * negative urinary cytology by instrumented collection
| Arm | Type | Description |
|---|---|---|
| padeliporfin VTP | EXPERIMENTAL | Induction Treatment phase:1-3 padeliporfin VTP treatments provided 4 weeks (28 +/-3 days) apart. Maintenance Treatment Phase: Repeated maintenance VTP treatments during this period will be provided for patients who show evidence of tumor recurrence that is deemed treatable. |
| Name | Type | Description |
|---|---|---|
| padeliporfin VTP | DRUG | During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes. |
Inclusion Criteria: * Male and female patients 18 years or older * Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study * New or recurrent low-grade, non-invasive UTUC disease * Biopsy-proven disease . A concurrence of...
Padeliporfin VTP is an investigational small molecule being studied for the treatment of transitional cell cancer of the renal pelvis and ureter, a type of upper tract urothelial cancer. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Padeliporfin VTP is a small molecule that is activated by light in a procedure called vascular targeted photodynamic therapy. The drug is designed to be activated within the tumor to destroy cancer cells, though its specific molecular target has not been disclosed.
Padeliporfin VTP is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 3 clinical trials for the treatment of transitional cell cancer of the renal pelvis and ureter.
Padeliporfin VTP is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 3 trial is active but not recruiting participants, with an enrollment target of 89 patients.
Padeliporfin VTP is being evaluated in a Phase 3 clinical trial with the identifier NCT04620239, known as the ENLIGHTED study. This trial is active but not recruiting and is being conducted in the United States, France, Germany, Israel, and Spain.
Padeliporfin VTP is a distinct investigational therapy being studied specifically for transitional cell cancer of the renal pelvis and ureter. It is not known to be the same as any other approved treatment, and its unique mechanism involves light-activated destruction of tumor tissue.