NCT00890903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

3.1 years

First QC Date

April 29, 2009

Last Update Submit

June 28, 2012

Conditions

Non Small Cell Lung CarcinomaMetastatic Breast Cancer

Keywords

NSCLCnon small cell lung carcinomametastatic breast cancerMBCadvanced breast cancerNavelbineNavelbine-ORALVinorelbineVinorelbine-ORALdaily routineconcomitant antiemetic therapypatient compliancegermanynon-interventional studyoral anti cancer therapyquality of life

Outcome Measures

Primary Outcomes (1)

  • Progression-free-survival

    1 year after LPI

Secondary Outcomes (7)

  • Time to progression

    1 year after LPI

  • Adverse reactions

    1 year after LPI

  • Concomitant antiemetic therapy

    1 year after LPI

  • Patient compliance

    1 year after LPI

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

    1 year after LPI

  • +2 more secondary outcomes

Study Arms (2)

NSCLC

Patients with advanced non-small cell lung cancer

MBC

Female patients with metastatic, Anthracycline-resistent breast cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy and nursing
  • lack of signed Patient informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, 79111, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBreast NeoplasmsPatient Compliance

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

April 30, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

DE(1)