JAVLOR® Online Non-Interventional Trial
Completed
- Conditions
- Transitional Cell Carcinoma
- Registration Number
- NCT01103544
- Lead Sponsor
- Pierre Fabre Pharma GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine 9 months after LPI
- Secondary Outcome Measures
Name Time Method Explorative assessment of Overall Response Rate (ORR) 9 months after LPI Anti-emetic comedication 9 months after LPI Anti-obstipative diet / comedication 9 months after LPI General well-being / quality of life of the patients (patient questionnaire) 9 months after LPI Patients' satisfaction with the treatment (patient questionnaire) 9 months after LPI Physicians' satisfaction with the treatment 9 months after LPI Patients' compliance with regards to the cotreatments (patient questionnaire) 9 months after LPI
Trial Locations
- Locations (1)
Pierre Fabre Pharma GmbH
🇩🇪Freiburg, Germany
Pierre Fabre Pharma GmbH🇩🇪Freiburg, Germany