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Completed

NCT Number: NCT01103544

JAVLOR® Online Non-Interventional Trial

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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Key information

Conditions

Transitional Cell Carcinoma Behavior Carcinoma Carcinoma, Transitional Cell Health Behavior Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine

    Time frame: 9 months after LPI

Secondary outcomes

  1. Explorative assessment of Overall Response Rate (ORR)

    Time frame: 9 months after LPI

  2. Anti-emetic comedication

    Time frame: 9 months after LPI

  3. Anti-obstipative diet / comedication

    Time frame: 9 months after LPI

  4. General well-being / quality of life of the patients (patient questionnaire)

    Time frame: 9 months after LPI

  5. Patients' satisfaction with the treatment (patient questionnaire)

    Time frame: 9 months after LPI

  6. Physicians' satisfaction with the treatment

    Time frame: 9 months after LPI

  7. Patients' compliance with regards to the cotreatments (patient questionnaire)

    Time frame: 9 months after LPI

Sponsors and collaborators

Lead sponsor

Pierre Fabre Pharma GmbH

Industry

Collaborators

  • DocCheck Medical Services GmbH

Registry information

Official study 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

Acronym: JONAS-1

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Apr 14, 2010
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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