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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01103544

Acronym

JONAS-1

Enrollment

200

Registered

2010-04-14

Start date

2010-04-30

Completion date

2013-08-31

Last updated

2015-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transitional Cell Carcinoma

Keywords

TCCU, advanced TCCU, metastatic TCCU, transitional cell carcinoma of the urothelium, advanced transitional cell carcinoma of the urothelium, metastatic transitional cell carcinoma of the urothelium, Cisplatinum failure, Vinflunine, Javlor, daily routine, concomitant antiemetic treatment, concomitant antiobstipative treatment, concomitant antiobstipative diet, patient compliance, quality of life, non-interventional study, Germany, Advanced / metastatic TCCU after Cisplatinum-failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine	9 months after LPI

Secondary

Measure	Time frame
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
Explorative assessment of Overall Response Rate (ORR)	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
Patients' satisfaction with the treatment (patient questionnaire)	9 months after LPI

Countries

Germany

Outcome results