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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103544
First Posted: April 14, 2010
Last Update Posted: May 13, 2015
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.
Collaborator:
DocCheck Medical Services GmbH
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH
  Purpose
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.

Condition
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)
Groups/Cohorts
Patients with advanced / metastatic TCCU after CDDP-failure

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103544


Locations
Germany
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
ClinicalTrials.gov Identifier: NCT01103544     History of Changes
Other Study ID Numbers: JONAS-1
First Submitted: April 11, 2010
First Posted: April 14, 2010
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Pierre Fabre Pharma GmbH:
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Antineoplastic Agents