JAVLOR® Online Non-Interventional Trial (JONAS-1)
This study is ongoing, but not recruiting participants.
Sponsor:
Pierre Fabre Pharma GmbH
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
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Purpose
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.
| Condition |
|---|
|
Transitional Cell Carcinoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pierre Fabre Pharma GmbH:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Patients with advanced / metastatic TCCU after CDDP-failure |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Pierre Fabre Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01103544 History of Changes |
| Other Study ID Numbers: | JONAS-1 |
| Study First Received: | April 11, 2010 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Pierre Fabre Pharma GmbH:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013