Non-Interventional Study With Vinorelbine ORAL in Advance... | NCT00890903

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

NCT00890903

Sponsor

Pierre Fabre Pharma GmbH

Status

Completed

Last Update Posted

Jul 2, 2012Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Non Small Cell Lung Carcinoma
Metastatic Breast Cancer

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Apr 29, 2009

First Submission Date that Met QC Criteria

Apr 29, 2009

First Posted Date

Apr 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2012

Last Update Posted Date

Jul 2, 2012Estimated

Name	Class
iOMEDICO AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Conditions Module

Conditions

Non Small Cell Lung Carcinoma
Metastatic Breast Cancer

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSCLC		Patients with advanced non-small cell lung cancer
MBC		Female patients with metastatic, Anthracycline-resistent breast cancer

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free-survival		1 year after LPI

Secondary Outcomes

Measure	Description	Time Frame
Time to progression		1 year after LPI
Adverse reactions		1 year after LPI
Concomitant antiemetic therapy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pierre Fabre Pharma GmbH		Freiburg im Breisgau		79111	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D001943	Breast Neoplasms
D010349	Patient Compliance

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided