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Pazopanib as add-on to vinflunine · 1 trial · 1 indication
MTD ist defined as the dose level with dose-limiting toxicity occurring in maximum one out of six patients.
Progression-free survival will be assessed by means of RECIST 1.1. methodology
| Arm | Type | Description |
|---|---|---|
| Pazopanib + Vinflunine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pazopanib as add-on to vinflunine | DRUG | Patients will receive vinflunine standard regimen (intravenous infusion every three weeks) as specified per drug label plus additional pazopanib as daily oral medication. Doses of pazopanib will be escalated in 200 mg/d steps during phase I up to a maximum of 800 mg/d. In Phase II the patients will be given pazopanib + vinflunine at maximum tolerated dose. |
Inclusion Criteria: * Written informed consent * Age ≥ 18 years * Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) with lymphatic (N-stage 2-3) and/or distant metastases (M-stage 1) not amenable to definitive regional/local therapy * Progression of tumor disease after p...
Pazopanib as add-on to vinflunine is used for advanced urothelial cancer of the bladder after failure of platinum-containing therapy. It is an investigational small molecule combination being studied in oncology. The treatment is intended for patients whose disease has progressed following prior platinum-based treatment.
Pazopanib as add-on to vinflunine is being developed by SS Innovations International Inc., which trades under the ticker SSII. The company is conducting clinical research on this combination therapy for advanced urothelial cancer of the bladder.
Pazopanib as add-on to vinflunine is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results informing further development decisions.
Pazopanib as add-on to vinflunine has one completed clinical trial, NCT01265940, titled 'Pazopanib and Vinflunine in Urothelial Cancer of the Bladder'. This Phase 1 study enrolled 5 participants in Germany and was an uncontrolled, non-randomized, open-label trial.
Pazopanib as add-on to vinflunine is a combination regimen that includes pazopanib plus vinflunine, whereas pazopanib alone is a single-agent therapy. The combination is being studied specifically for advanced urothelial cancer of the bladder after failure of platinum-containing therapy.