JAVLOR® Online Non-Interventional Trial

Transitional Cell Carcinoma Clinical Trial

— JONAS-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103544
• Other study ID #: JONAS-1
• Status: Completed
• Phase: N/A
• First received: April 11, 2010
• Last updated: May 12, 2015
• Start date: April 2010
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: Pierre Fabre Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma

Locations

Country	Name	City	State
Germany	Pierre Fabre Pharma GmbH	Freiburg

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Pharma GmbH	DocCheck Medical Services GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine		9 months after LPI	Yes
Secondary	Explorative assessment of Overall Response Rate (ORR)		9 months after LPI	No
Secondary	Anti-emetic comedication		9 months after LPI	No
Secondary	Anti-obstipative diet / comedication		9 months after LPI	No
Secondary	General well-being / quality of life of the patients (patient questionnaire)		9 months after LPI	No
Secondary	Patients' satisfaction with the treatment (patient questionnaire)		9 months after LPI	No
Secondary	Physicians' satisfaction with the treatment		9 months after LPI	No
Secondary	Patients' compliance with regards to the cotreatments (patient questionnaire)		9 months after LPI	No