NCT01103544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

April 11, 2010

Last Update Submit

May 12, 2015

Conditions

Transitional Cell Carcinoma

Keywords

TCCUadvanced TCCUmetastatic TCCUtransitional cell carcinoma of the urotheliumadvanced transitional cell carcinoma of the urotheliummetastatic transitional cell carcinoma of the urotheliumCisplatinum failureVinflunineJavlordaily routineconcomitant antiemetic treatmentconcomitant antiobstipative treatmentconcomitant antiobstipative dietpatient compliancequality of lifenon-interventional studyGermanyAdvanced / metastatic TCCU after Cisplatinum-failure

Outcome Measures

Primary Outcomes (1)

  • Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine

    9 months after LPI

Secondary Outcomes (7)

  • Explorative assessment of Overall Response Rate (ORR)

    9 months after LPI

  • Anti-emetic comedication

    9 months after LPI

  • Anti-obstipative diet / comedication

    9 months after LPI

  • General well-being / quality of life of the patients (patient questionnaire)

    9 months after LPI

  • Patients' satisfaction with the treatment (patient questionnaire)

    9 months after LPI

  • +2 more secondary outcomes

Study Arms (1)

Patients with advanced / metastatic TCCU after CDDP-failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with advanced or metastatic transitional cell carcinoma of the urothelium after failure of a Cisplatinum-containing therapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Carcinoma, Transitional CellPatient Compliance

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2010

First Posted

April 14, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2011

Study Completion

August 1, 2013

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

DE(1)