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OpenTrials
Completed

NCT Number: NCT00890903

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

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.

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Key information

Conditions

Non Small Cell Lung Carcinoma Behavior Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Health Behavior Lung Diseases Lung Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, 79111, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-free-survival

    Time frame: 1 year after LPI

Secondary outcomes

  1. Time to progression

    Time frame: 1 year after LPI

  2. Adverse reactions

    Time frame: 1 year after LPI

  3. Concomitant antiemetic therapy

    Time frame: 1 year after LPI

  4. Patient compliance

    Time frame: 1 year after LPI

  5. Recording of combinations of applied capsules (requested by a patients' questionnaire)

    Time frame: 1 year after LPI

  6. General condition of patients (requested by a patients' questionnaire)

    Time frame: 1 year after LPI

  7. Therapy performance in the daily routine

    Time frame: 1 year after LPI

Sponsors and collaborators

Lead sponsor

Pierre Fabre Pharma GmbH

Industry

Collaborators

  • iOMEDICO AG

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2009
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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