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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Transitional Cell Carcinoma

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine

Outcome Time Frame:

9 months after LPI

Safety Issue:

Yes

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

JONAS-1

NCT ID:

NCT01103544

Start Date:

April 2010

Completion Date:

October 2012

Related Keywords:

  • Transitional Cell Carcinoma
  • 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
  • Carcinoma
  • Carcinoma, Transitional Cell

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