- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01103544
JAVLOR® Online Non-Interventional Trial (JONAS-1)
May 12, 2015 updated by: Pierre Fabre Pharma GmbH
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Freiburg, Germany
- Pierre Fabre Pharma GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Patients with advanced / metastatic TCCU after CDDP-failure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
Time Frame: 9 months after LPI
|
9 months after LPI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Explorative assessment of Overall Response Rate (ORR)
Time Frame: 9 months after LPI
|
9 months after LPI
|
Anti-emetic comedication
Time Frame: 9 months after LPI
|
9 months after LPI
|
Anti-obstipative diet / comedication
Time Frame: 9 months after LPI
|
9 months after LPI
|
General well-being / quality of life of the patients (patient questionnaire)
Time Frame: 9 months after LPI
|
9 months after LPI
|
Patients' satisfaction with the treatment (patient questionnaire)
Time Frame: 9 months after LPI
|
9 months after LPI
|
Physicians' satisfaction with the treatment
Time Frame: 9 months after LPI
|
9 months after LPI
|
Patients' compliance with regards to the cotreatments (patient questionnaire)
Time Frame: 9 months after LPI
|
9 months after LPI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
April 11, 2010
First Submitted That Met QC Criteria
April 13, 2010
First Posted (Estimate)
April 14, 2010
Study Record Updates
Last Update Posted (Estimate)
May 13, 2015
Last Update Submitted That Met QC Criteria
May 12, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
- quality of life
- non-interventional study
- Germany
- transitional cell carcinoma of the urothelium
- patient compliance
- TCCU
- Vinflunine
- daily routine
- Javlor
- advanced TCCU
- metastatic TCCU
- advanced transitional cell carcinoma of the urothelium
- metastatic transitional cell carcinoma of the urothelium
- Cisplatinum failure
- concomitant antiemetic treatment
- concomitant antiobstipative treatment
- concomitant antiobstipative diet
- Advanced / metastatic TCCU after Cisplatinum-failure
Additional Relevant MeSH Terms
Other Study ID Numbers
- JONAS-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transitional Cell Carcinoma
-
Cliniques universitaires Saint-Luc- Université...NovartisTerminatedCarcinoma Transitional CellBelgium, Luxembourg
-
Associació per a la Recerca Oncologica, SpainUnknownUrothelium Transitional Cell CarcinomaSpain, Netherlands
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingTransitional Cell Carcinoma | Metastatic Urothelial Carcinoma | Unresectable Transitional Cell CarcinomaUnited States
-
UroGen Pharma Ltd.CompletedCarcinoma, Transitional Cell | Transitional Cell Carcinoma of Renal PelvisUnited States, Israel
-
Memorial Sloan Kettering Cancer CenterNovartisCompletedMetastatic Transitional Cell Carcinoma of the UrotheliumUnited States
-
Institute of Cancer Research, United KingdomCancer Research UKUnknownTransitional Cell Carcinoma of UreterUnited Kingdom
-
Shaheen AlaneeMerck Sharp & Dohme LLCUnknownEndoscopic Surgical Procedure | High Risk Superficial Upper Urinary Tract Transitional Cell Carcinoma | Transitional Epithelial CellsUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedTransitional Cell Carcinoma of Urinary TractNetherlands
-
Yale UniversityWithdrawnTransitional Cell CarcinomaUnited States
-
Chinese PLA General HospitalCompleted