Clinical trial · Observational
JAVLOR® Online Non-Interventional Trial
Usage of Vinflunine i.v. (JAVLOR®) for the Treatment of Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium in Adult Patients After Failure of a Cisplatinum-containing Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced / metastatic TCCU after CDDP-failure
Primary outcomes (1)
- measure
- Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
- timeFrame
- 9 months after LPI
Secondary outcomes (7)
- measure
- Explorative assessment of Overall Response Rate (ORR)
- timeFrame
- 9 months after LPI
- measure
- Anti-emetic comedication
- timeFrame
- 9 months after LPI
- measure
- Anti-obstipative diet / comedication
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available