Non Small Cell Lung CarcinomaNCT00890903
Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)
An observational study of Non Small Cell Lung Carcinoma and Metastatic Breast Cancer, run by Pierre Fabre Pharma GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma, Metastatic Breast Cancer
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced non-small cell lung cancer (NSCLC) or metastatic, Antracycline-resistant breast cancer, treated with Navelbine capsules
Who may be able to join
- 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
Who cannot join
- Pregnancy and nursing
- All other exclusion criteria listed in SPC (summary of product characteristics)
- lack of signed Patient informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | Patients with advanced non-small cell lung cancer | |
| MBC | Female patients with metastatic, Anthracycline-resistent breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-survival
Measured: 1 year after LPI
Secondary outcomes (7)
Time to progression
Measured: 1 year after LPI
Adverse reactions
Measured: 1 year after LPI
Concomitant antiemetic therapy
Measured: 1 year after LPI
Patient compliance
Measured: 1 year after LPI
Recording of combinations of applied capsules (requested by a patients' questionnaire)
Measured: 1 year after LPI
General condition of patients (requested by a patients' questionnaire)
Measured: 1 year after LPI
Therapy performance in the daily routine
Measured: 1 year after LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iOMEDICO AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890903
- Sponsor's protocol ID
- IOM-155
- Status last verified
- Jun 2012
- First submitted
- 29 Apr 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00890903
- Acronym / sponsor ID
- IOM-155
- Keywords
- NSCLC, non small cell lung carcinoma, metastatic breast cancer, MBC, advanced breast cancer, Navelbine, Navelbine-ORAL, Vinorelbine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Pierre Fabre Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- iOMEDICO AG
- Study start
- Mar 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | –Patients with advanced non-small cell lung cancer |
| MBC | – | –Female patients with metastatic, Anthracycline-resistent breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced non-small cell lung cancer (NSCLC) or metastatic, Antracycline-resistant breast cancer, treated with Navelbine capsules
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy and nursing
- All other exclusion criteria listed in SPC (summary of product characteristics)
- lack of signed Patient informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free-survival
Time frame: 1 year after LPI
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Carcinoma and Metastatic Breast Cancer, run by Pierre Fabre Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free-survival (time frame: 1 year after LPI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.