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

This study has been completed.
DocCheck Medical Services GmbH
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH Identifier:
First received: April 11, 2010
Last updated: May 12, 2015
Last verified: May 2015
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.

Transitional Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Pharma GmbH:

Primary Outcome Measures:
  • Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine [ Time Frame: 9 months after LPI ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: April 2010
Study Completion Date: August 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Patients with advanced / metastatic TCCU after CDDP-failure


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced or metastatic transitional cell carcinoma of the urothelium 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01103544

Pierre Fabre Pharma GmbH
Freiburg, Germany
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
DocCheck Medical Services GmbH
  More Information

Responsible Party: Pierre Fabre Pharma GmbH Identifier: NCT01103544     History of Changes
Other Study ID Numbers: JONAS-1
Study First Received: April 11, 2010
Last Updated: May 12, 2015

Keywords provided by Pierre Fabre Pharma GmbH:
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
daily routine
concomitant antiemetic treatment
concomitant antiobstipative treatment
concomitant antiobstipative diet
patient compliance
quality of life
non-interventional study
Advanced / metastatic TCCU after Cisplatinum-failure

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents processed this record on September 21, 2017