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

June 28, 2012 updated by: Pierre Fabre Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany, 79111
        • Pierre Fabre Pharma GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
NSCLC
Patients with advanced non-small cell lung cancer
MBC
Female patients with metastatic, Anthracycline-resistent breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free-survival
Time Frame: 1 year after LPI
1 year after LPI

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 1 year after LPI
1 year after LPI
Adverse reactions
Time Frame: 1 year after LPI
1 year after LPI
Concomitant antiemetic therapy
Time Frame: 1 year after LPI
1 year after LPI
Patient compliance
Time Frame: 1 year after LPI
1 year after LPI
Recording of combinations of applied capsules (requested by a patients' questionnaire)
Time Frame: 1 year after LPI
1 year after LPI
General condition of patients (requested by a patients' questionnaire)
Time Frame: 1 year after LPI
1 year after LPI
Therapy performance in the daily routine
Time Frame: 1 year after LPI
1 year after LPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Pharma GmbH

Collaborators

iOMEDICO AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 29, 2009

First Posted (Estimate)

April 30, 2009

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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