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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 11, 2010
Last Updated Date	June 28, 2012
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01103544 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 13, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	JAVLOR® Online Non-Interventional Trial
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
Condition ^ICMJE	Transitional Cell Carcinoma
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Patients with advanced / metastatic TCCU after CDDP-failure
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	October 2012
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01103544
Other Study ID Numbers ^ICMJE	JONAS-1
Has Data Monitoring Committee	No
Responsible Party	Pierre Fabre Pharma GmbH
Study Sponsor ^ICMJE	Pierre Fabre Pharma GmbH
Collaborators ^ICMJE	DocCheck Medical Services GmbH
Investigators ^ICMJE	Not Provided
Information Provided By	Pierre Fabre Pharma GmbH
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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