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NCT00890903 Clinical Trial

Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)

Metastatic Breast Cancer Clinical Trial

Official title:
Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00890903
Other study ID # IOM-155
Secondary ID
Status Completed
Phase N/A
First received April 29, 2009
Last updated June 28, 2012
Start date March 2009
Est. completion date April 2012

Study information
Verified date June 2012
Source Pierre Fabre Pharma GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18 years old

- Male and female patients

- Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC

- Therapy with Navelbine capsules in any palliative treatment line

- Signed patient informed consent

Exclusion Criteria:

- Pregnancy and nursing

- All other exclusion criteria listed in SPC (summary of product characteristics)

- lack of signed Patient informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Pierre Fabre Pharma GmbH Freiburg

Sponsors (2)
Lead Sponsor Collaborator
Pierre Fabre Pharma GmbH iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free-survival 1 year after LPI No
Secondary Time to progression 1 year after LPI No
Secondary Adverse reactions 1 year after LPI Yes
Secondary Concomitant antiemetic therapy 1 year after LPI No
Secondary Patient compliance 1 year after LPI No
Secondary Recording of combinations of applied capsules (requested by a patients' questionnaire) 1 year after LPI No
Secondary General condition of patients (requested by a patients' questionnaire) 1 year after LPI No
Secondary Therapy performance in the daily routine 1 year after LPI No
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