Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria

NCT ID: NCT02619929

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-03-31

Brief Summary

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.

Conditions

Non-Small-Cell Lung Cancer; Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Vinorelbine oral

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winicker Norimed GmbH

INDUSTRY

Sponsor Role: collaborator

Pierre Fabre Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Braunau am Inn, , Austria

Graz, , Austria

Innsbruck, , Austria

Klagenfurt, , Austria

Vienna, , Austria

Villach, , Austria

Vöcklabruck, , Austria

Aachen, , Germany

Altötting, , Germany

Amberg, , Germany

Bad Nauheim, , Germany

Ballenstedt, , Germany

Berlin, , Germany

Bielefeld, , Germany

Chemnitz, , Germany

Cologne, , Germany

Dessau, , Germany

Donauwörth, , Germany

Eggenfelden, , Germany

Erbach im Odenwald, , Germany

Erfurt, , Germany

Frankfurt am Main, , Germany

Göppingen, , Germany

Greifswald, , Germany

Güstrow, , Germany

Halle, , Germany

Hanover, , Germany

Heppenheim an der Bergstrasse, , Germany

Homburg, , Germany

Karlsruhe, , Germany

Kiel, , Germany

Kulmbach, , Germany

Lich, , Germany

Lostau, , Germany

Ludwigsburg, , Germany

Lübeck, , Germany

Mainz, , Germany

Mannheim, , Germany

Marktredwitz, , Germany

Memmingen, , Germany

Munich, , Germany

Münster, , Germany

Offenbach, , Germany

Offenburg, , Germany

Ostfildern, , Germany

Regensburg, , Germany

Saarbrücken, , Germany

Schwandorf in Bayern, , Germany

Solingen, , Germany

Stolberg, , Germany

Villingen-Schwenningen, , Germany

Waltershausen, , Germany

Weinheim, , Germany

Werdau, , Germany

Wesel, , Germany

Winnenden, , Germany

Countries

Austria; Germany

Other Identifiers

DE2015026

Identifier Type: -

Identifier Source: org_study_id