Text Size

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

This study has been completed.
Sponsor:
Collaborator:
iOMEDICO AG
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00890903
First received: April 29, 2009
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Non Small Cell Lung Carcinoma
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pierre Fabre Pharma GmbH:

Primary Outcome Measures:
  • Progression-free-survival [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]
  • Adverse reactions [ Time Frame: 1 year after LPI ] [ Designated as safety issue: Yes ]
  • Concomitant antiemetic therapy [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]
  • Patient compliance [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]
  • Recording of combinations of applied capsules (requested by a patients' questionnaire) [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]
  • General condition of patients (requested by a patients' questionnaire) [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]
  • Therapy performance in the daily routine [ Time Frame: 1 year after LPI ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: March 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
NSCLC
Patients with advanced non-small cell lung cancer
MBC
Female patients with metastatic, Anthracycline-resistent breast cancer

  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 non-small cell lung cancer (NSCLC) or metastatic, Antracycline-resistant breast cancer, treated with Navelbine capsules

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890903

Locations
Germany
Pierre Fabre Pharma GmbH
Freiburg, Germany, 79111
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
iOMEDICO AG
  More Information

No publications provided

Responsible Party: Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier: NCT00890903     History of Changes
Other Study ID Numbers: IOM-155
Study First Received: April 29, 2009
Last Updated: June 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pierre Fabre Pharma GmbH:
NSCLC
non small cell lung carcinoma
metastatic breast cancer
MBC
advanced breast cancer
Navelbine
Navelbine-ORAL
Vinorelbine
 Vinorelbine-ORAL
daily routine
concomitant antiemetic therapy
patient compliance
germany
non-interventional study
oral anti cancer therapy
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013