JAVLOR® Online Non-Interventional Trial

Pierre Fabre Pharma GmbH200 enrolled

Overview

Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Transitional Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years old * Legally competent male and female patients * Advanced or metastatic transitional cell carcinoma of the urothelium * Failure of a prior Cisplatinum-containing treatment * Performance Status 0 or 1 * Signed patient informed consent Exclusion Criteria: * Missing signed patient informed consent * Performance Status 2 or higher * Life expectancy \< 2 months * Brain metastases * Creatinine-clearance \< 20 ml/min * Child-Pugh-stadium C * Prothrombin time \< 50% * Bilirubin \> 5 x ULN * Transaminases \> 6 x ULN * Gamma-Glutamyl-transferase \> 15 x ULN * Pregnant or breast-feeding women * Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids * Recent (within the last 2 weeks) or current severe infections * Baseline ANC \< 1,500/mm3 or platelets \< 100,000/mm3 * Patients being institutionalised due to court/regulatory order

Locations (1)

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, Germany