Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria (StepUp)

August 28, 2018 updated by: Pierre Fabre Pharma GmbH

Assessment of Initial Oral Vinorelbine Dosing Schedules Used for the Treatment of Advanced Non-small-cell Lung Cancer and Metastatic Breast Cancer in Clinical Routine in Germany and Austria (StepUp)

The aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in Germany together with the underlying reasons for the respective chosen schedules.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

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

  • Austria
      • Braunau Am Inn, Austria
      • Graz, Austria
      • Innsbruck, Austria
      • Klagenfurt, Austria
      • Vienna, Austria
      • Villach, Austria
      • Vöcklabruck, Austria
  • Germany
      • Aachen, Germany
      • Altoetting, Germany
      • Amberg, Germany
      • Bad Nauheim, Germany
      • Ballenstedt, Germany
      • Berlin, Germany
      • Bielefeld, Germany
      • Chemnitz, Germany
      • Cologne, Germany
      • Dessau, Germany
      • Donauwoerth, Germany
      • Eggenfelden, Germany
      • Erbach, Germany
      • Erfurt, Germany
      • Frankfurt/Main, Germany
      • Goeppingen, Germany
      • Greifswald, Germany
      • Guestrow, Germany
      • Halle/Saale, Germany
      • Hannover, Germany
      • Heppenheim, Germany
      • Homburg, Germany
      • Karlsruhe, Germany
      • Kiel, Germany
      • Kulmbach, Germany
      • Lich, Germany
      • Lostau, Germany
      • Ludwigsburg, Germany
      • Luebeck, Germany
      • Mainz, Germany
      • Mannheim, Germany
      • Marktredwitz, Germany
      • Memmingen, Germany
      • Munich, Germany
      • Münster, Germany
      • Offenbach, Germany
      • Offenburg, Germany
      • Ostfildern, Germany
      • Regensburg, Germany
      • Saarbruecken, Germany
      • Schwandorf, Germany
      • Solingen, Germany
      • Stolberg, Germany
      • Villingen-Schwenningen, Germany
      • Waltershausen, Germany
      • Weinheim, Germany
      • Werdau, Germany
      • Wesel, Germany
      • Winnenden, Germany

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Palliative patients with advanced non-small-cell lung cancer (NSCLC, stage III and IV) or anthracycline/taxane-resistant metastatic breast cancer (MBC, stage IV)

Description

Inclusion Criteria:

  • Written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data
  • Legally capable male or female NSCLC patient or legally capable female MBC patient; in both situations: ≥ 18 years of age (no upper limit)

  • Presence of any of the following two tumor entities:

    • Advanced NSCLC (stage III or IV)
    • Anthracycline- and taxane-resistant MBC (stage IV) in women

  • Planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments:

    • Monotherapy or any combination therapy with oral vinorelbine
    • Inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed

Exclusion Criteria:

  • Presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective Summary of Product Characteristics (SmPC)
  • Oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of >60 mg/m2
  • Presence of a Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 2
  • Simultaneous participation in an interventional clinical trial

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study
Time Frame: 8 weeks of treatment
The outcome will be calculated together with its negative (i.e. the rate of patients without such dose increase). Reasons for increasing and for not increasing the dose will be analyzed.
8 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Baseline and 8 weeks of treatment
Body weight [kg] at baseline and changes during the study
Baseline and 8 weeks of treatment
Body mass index
Time Frame: Baseline and 8 weeks of treatment
Body mass index [kg/m^2] at baseline and changes during the study
Baseline and 8 weeks of treatment
Body surface area
Time Frame: Baseline and 8 weeks of treatment
Body surface area [m^2] at baseline and changes during the study
Baseline and 8 weeks of treatment
ECOG performance status
Time Frame: Baseline and 8 weeks of treatment
ECOG performance status [grades 0-5] at baseline and changes during the study
Baseline and 8 weeks of treatment
Treatment regimen
Time Frame: Baseline
Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed.
Baseline
Treatment changes
Time Frame: 8 weeks of treatment
Frequency analysis of dose changes and of the underlying reasons
8 weeks of treatment
Relationships between oral vinorelbine dose increases and patient and disease characteristics
Time Frame: Baseline and 8 weeks of treatment
Generalized linear mixed model with the variable "dose increase" as binary response variable
Baseline and 8 weeks of treatment
Assessment of initial tumor response (based on clinical or imaging assessment)
Time Frame: 8 weeks of treatment
8 weeks of treatment
Patient's quality of life
Time Frame: Baseline and 8 weeks of treatment
Evaluation of the patient's quality of life [Short Form (SF)-12]
Baseline and 8 weeks of treatment
Patient's treatment satisfaction
Time Frame: 8 weeks of treatment
Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]
8 weeks of treatment
Physician's treatment satisfaction
Time Frame: 8 weeks of treatment
Evaluation of the physician's treatment satisfaction [5 point scale]
8 weeks of treatment
Adverse drug reactions
Time Frame: 8 weeks of treatment
Evaluation of adverse drug reactions using CTCAE v4.03
8 weeks of treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pierre Fabre Pharma GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Winicker Norimed GmbH

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DE2015026

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings