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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103544
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : May 13, 2015
DocCheck Medical Services GmbH
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

April 11, 2010
April 14, 2010
May 13, 2015
April 2010
September 2011   (Final data collection date for primary outcome measure)
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine [ Time Frame: 9 months after LPI ]
Same as current
Complete list of historical versions of study NCT01103544 on Archive Site
  • Explorative assessment of Overall Response Rate (ORR) [ Time Frame: 9 months after LPI ]
  • Anti-emetic comedication [ Time Frame: 9 months after LPI ]
  • Anti-obstipative diet / comedication [ Time Frame: 9 months after LPI ]
  • General well-being / quality of life of the patients (patient questionnaire) [ Time Frame: 9 months after LPI ]
  • Patients' satisfaction with the treatment (patient questionnaire) [ Time Frame: 9 months after LPI ]
  • Physicians' satisfaction with the treatment [ Time Frame: 9 months after LPI ]
  • Patients' compliance with regards to the cotreatments (patient questionnaire) [ Time Frame: 9 months after LPI ]
Same as current
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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
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
Transitional Cell Carcinoma
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Patients with advanced / metastatic TCCU after CDDP-failure
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2013
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Pierre Fabre Pharma GmbH
Pierre Fabre Pharma GmbH
DocCheck Medical Services GmbH
Not Provided
Pierre Fabre Pharma GmbH
May 2015