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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DocCheck Medical Services GmbH
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01103544
First received: April 11, 2010
Last updated: June 28, 2012
Last verified: June 2012

April 11, 2010
June 28, 2012
April 2010
October 2012   (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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01103544 on ClinicalTrials.gov Archive Site
  • Explorative assessment of Overall Response Rate (ORR) [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
  • Anti-emetic comedication [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
  • Anti-obstipative diet / comedication [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
  • General well-being / quality of life of the patients (patient questionnaire) [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
  • Patients' satisfaction with the treatment (patient questionnaire) [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
  • Physicians' satisfaction with the treatment [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
  • Patients' compliance with regards to the cotreatments (patient questionnaire) [ Time Frame: 9 months after LPI ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy

Transitional Cell Carcinoma
Not Provided
Patients with advanced / metastatic TCCU after CDDP-failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
October 2012
October 2012   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01103544
JONAS-1
No
Pierre Fabre Pharma GmbH
Pierre Fabre Pharma GmbH
DocCheck Medical Services GmbH
Not Provided
Pierre Fabre Pharma GmbH
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP