JAVLOR® Online Non-Interventional Trial (JONAS-1)

Pierre Fabre

Status: Completed

Conditions: Transitional Cell Carcinoma

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01103544

JONAS-1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patients with advanced / metastatic TCCU after CDDP-failure