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

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ClinicalTrials.gov Identifier: NCT02619929
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Winicker Norimed GmbH
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

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.

Condition or disease Intervention/treatment
Non-Small-Cell Lung Cancer Breast Cancer Drug: Vinorelbine oral

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : February 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Baseline and 8 weeks of treatment ]
    Body weight [kg] at baseline and changes during the study

  2. Body mass index [ Time Frame: Baseline and 8 weeks of treatment ]
    Body mass index [kg/m^2] at baseline and changes during the study

  3. Body surface area [ Time Frame: Baseline and 8 weeks of treatment ]
    Body surface area [m^2] at baseline and changes during the study

  4. ECOG performance status [ Time Frame: Baseline and 8 weeks of treatment ]
    ECOG performance status [grades 0-5] at baseline and changes during the study

  5. 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.

  6. Treatment changes [ Time Frame: 8 weeks of treatment ]
    Frequency analysis of dose changes and of the underlying reasons

  7. 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

  8. Assessment of initial tumor response (based on clinical or imaging assessment) [ Time Frame: 8 weeks of treatment ]
  9. 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]

  10. Patient's treatment satisfaction [ Time Frame: 8 weeks of treatment ]
    Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]

  11. Physician's treatment satisfaction [ Time Frame: 8 weeks of treatment ]
    Evaluation of the physician's treatment satisfaction [5 point scale]

  12. Adverse drug reactions [ Time Frame: 8 weeks of treatment ]
    Evaluation of adverse drug reactions using CTCAE v4.03



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619929


Locations
Show Show 56 study locations
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
Winicker Norimed GmbH
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Responsible Party: Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier: NCT02619929    
Other Study ID Numbers: DE2015026
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Pierre Fabre Pharma GmbH:
Oral Vinorelbine
Advanced Non-Small-Cell Lung Cancer
Metastatic Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action