Transitional Cell CarcinomaJONAS-1NCT01103544
JAVLOR® Online Non-Interventional Trial
An observational study of Transitional Cell Carcinoma, run by Pierre Fabre Pharma GmbH at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Transitional Cell Carcinoma
- Keywords
- 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
- Medical subject headings
- Carcinoma, Transitional Cell, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced / metastatic TCCU after CDDP-failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
Measured: 9 months after LPI
Secondary outcomes (7)
Explorative assessment of Overall Response Rate (ORR)
Measured: 9 months after LPI
Anti-emetic comedication
Measured: 9 months after LPI
Anti-obstipative diet / comedication
Measured: 9 months after LPI
General well-being / quality of life of the patients (patient questionnaire)
Measured: 9 months after LPI
Patients' satisfaction with the treatment (patient questionnaire)
Measured: 9 months after LPI
Physicians' satisfaction with the treatment
Measured: 9 months after LPI
Patients' compliance with regards to the cotreatments (patient questionnaire)
Measured: 9 months after LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DocCheck Medical Services GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103544
- Sponsor's protocol ID
- JONAS-1
- Acronym
- JONAS-1
- Status last verified
- May 2015
- First submitted
- 11 Apr 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01103544
- Acronym / sponsor ID
- JONAS-1 / JONAS-1
- Conditions
- Transitional Cell Carcinoma
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pierre Fabre Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- DocCheck Medical Services GmbH
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced / metastatic TCCU after CDDP-failure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Missing signed patient informed consent
- Performance Status 2 or higher
- Life expectancy < 2 months
- Brain metastases
- Creatinine-clearance < 20 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine
Time frame: 9 months after LPI
7 secondary outcomes
Explorative assessment of Overall Response Rate (ORR)
Time frame: 9 months after LPI
Anti-emetic comedication
Time frame: 9 months after LPI
Anti-obstipative diet / comedication
Time frame: 9 months after LPI
General well-being / quality of life of the patients (patient questionnaire)
Time frame: 9 months after LPI
Patients' satisfaction with the treatment (patient questionnaire)
Time frame: 9 months after LPI
Physicians' satisfaction with the treatment
Time frame: 9 months after LPI
Patients' compliance with regards to the cotreatments (patient questionnaire)
Time frame: 9 months after LPI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transitional Cell Carcinoma, run by Pierre Fabre Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine (time frame: 9 months after LPI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.