JONAS-1: JAVLOR® Online Non-Interventional Trial

• Sponsor: Pierre Fabre Pharma GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01103544
• Collaborator: DocCheck Medical Services GmbH (Other)
• Enrollment: 200
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transitional Cell Carcinoma

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patients with advanced / metastatic TCCU after CDDP-failure

Outcome Measures

Primary Outcome Measures

1. Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine [9 months after LPI]

Secondary Outcome Measures

1. Explorative assessment of Overall Response Rate (ORR) [9 months after LPI]

2. Anti-emetic comedication [9 months after LPI]

3. Anti-obstipative diet / comedication [9 months after LPI]

4. General well-being / quality of life of the patients (patient questionnaire) [9 months after LPI]

5. Patients' satisfaction with the treatment (patient questionnaire) [9 months after LPI]

6. Physicians' satisfaction with the treatment [9 months after LPI]

7. Patients' compliance with regards to the cotreatments (patient questionnaire) [9 months after LPI]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pierre Fabre Pharma GmbH	Freiburg		Germany

Sponsors and Collaborators

• Pierre Fabre Pharma GmbH
• DocCheck Medical Services GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pierre Fabre Pharma GmbH
• ClinicalTrials.gov Identifier: NCT01103544
• Other Study ID Numbers: JONAS-1
• First Posted: Apr 14, 2010
• Last Update Posted: May 13, 2015
• Last Verified: May 1, 2015

• 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

Study Results

No Results Posted as of May 13, 2015