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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00890903
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : July 2, 2012
Sponsor:
Collaborator:
iOMEDICO AG
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

Tracking Information
First Submitted Date April 29, 2009
First Posted Date April 30, 2009
Last Update Posted Date July 2, 2012
Study Start Date March 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2009)
Progression-free-survival [ Time Frame: 1 year after LPI ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 29, 2009)
  • Time to progression [ Time Frame: 1 year after LPI ]
  • Adverse reactions [ Time Frame: 1 year after LPI ]
  • Concomitant antiemetic therapy [ Time Frame: 1 year after LPI ]
  • Patient compliance [ Time Frame: 1 year after LPI ]
  • Recording of combinations of applied capsules (requested by a patients' questionnaire) [ Time Frame: 1 year after LPI ]
  • General condition of patients (requested by a patients' questionnaire) [ Time Frame: 1 year after LPI ]
  • Therapy performance in the daily routine [ Time Frame: 1 year after LPI ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)
Official Title Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Non Small Cell Lung Carcinoma
  • Metastatic Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • NSCLC
    Patients with advanced non-small cell lung cancer
  • MBC
    Female patients with metastatic, Anthracycline-resistent breast cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2012)
62
Original Estimated Enrollment
 (submitted: April 29, 2009)
350
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00890903
Other Study ID Numbers IOM-155
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pierre Fabre Pharma GmbH
Study Sponsor Pierre Fabre Pharma GmbH
Collaborators iOMEDICO AG
Investigators Not Provided
PRS Account Pierre Fabre Pharma GmbH
Verification Date June 2012