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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Pierre Fabre Pharma GmbH.
Recruitment status was  Active, not recruiting
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
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with advanced / metastatic TCCU after CDDP-failure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103544

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

No publications provided

Responsible Party: Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier: NCT01103544     History of Changes
Other Study ID Numbers: JONAS-1
Study First Received: April 11, 2010
Last Updated: June 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014