Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vinflunine · 1 trial · 5 indications
Primary endpoint: Define the recommended phase II dose (RPTD) by the number of dose limiting toxicity events (recorded during treatment cycle 1 and 2)
| Arm | Type | Description |
|---|---|---|
| vinflunine + sorafenib | EXPERIMENTAL | Single arm study. |
| Name | Type | Description |
|---|---|---|
| Vinflunine | DRUG | Vinflunine (Javlor®, Pierre Fabre Pharma): 320 mg/m2 I.V., day 1, repeated every 21 days for patients with PS 0, adequate renal (creatinine clearance \>60 ml/min) and hepatic function (as described in the inclusion criteria). PLEASE NOTE THAT THE 320 mg/m2 ARM IS CLOSED FOR RECRUITMENT. For patients with PS 1, or age 75 to 80 years, or exposed to radiation of the lower pelvis region, or with impaired renal function (creatinine clearance 40-60 ml/min) but adequate hepatic function (as described in the inclusion criteria), the dose of vinflunine is 280 mg/m2 I.V. day 1, repeated every 21 days. |
| Sorafenib | DRUG | Sorafenib (Nexavar®, Bayer HealthCare) daily dosage from day 2 through day 21 (repeated every 21 days): Step 1: 400 mg P.O. (i.e. one (1) tablet 200 mg morning and evening, 1+0+1) Step 2: 600 P.O. (i.e. one (1) tablet 200 mg morning and two tablets evening, 1+0+2) Step 3: 800 mg P.O. (i.e. two (2) tablets 200 mg morning and evening, 2+0+2) Doses of sorafenib higher than 400 mg P.O. b.i.d. are not allowed. |
Inclusion Criteria: * signed informed consent; * histologically confirmed transitional cell (pure or mixed histology including transitional cell carcinoma are allowed) carcinoma of the urothelial tract; * patients who have received neoadjuvant or adjuvant platinum-containing chemotherapy and who ar...
Vinflunine is a small molecule oncology drug being investigated for the treatment of urothelial carcinoma, which includes cancers of the bladder, renal pelvis, ureter, and urethra. It is currently in clinical development and is not approved for this use.
Vinflunine is being developed by Bayer AG, a company traded on the OTC market under the ticker BAYRY. The drug is in Phase 1 clinical development for urothelial carcinoma.
Vinflunine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Vinflunine has been studied in a completed Phase 1 trial with the identifier NCT01844947. This trial evaluated the combination of sorafenib and vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract and enrolled 22 participants in Denmark and Sweden.
No, Vinflunine is not the same as sorafenib. Vinflunine is the investigational drug being studied, while sorafenib is a separate agent that was added to vinflunine in a Phase 1 clinical trial for metastatic urothelial carcinoma.