Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

July 27, 2015 updated by: Hospira, now a wholly owned subsidiary of Pfizer

Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

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.
2114

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

  • France
      • Marseille, France
        • CHU Timone
      • Marseille, France
        • IPC
      • Marseille, France
        • CHP Clairval
      • Marseille, France
        • Fondation Saint Joseph
      • Marseille, France
        • Hopital A.Pare
    • Alsace
      • Colmar, Alsace, France
        • Hôpital Louis Pasteur
      • Epinal, Alsace, France
        • Hopital Jean Monnet
      • Mulhouse, Alsace, France
        • CH Emile Muller
      • Strasbourg, Alsace, France
        • CAC Paul Strauss
      • Strasbourg, Alsace, France
        • Chu Hopital Civil
      • Strasbourg, Alsace, France
        • Ste Anne
    • Basse Normandie
      • Cesson, Basse Normandie, France
        • Polyclinique Cesson
      • Rennes, Basse Normandie, France
        • CHU Rennes
      • Rennes, Basse Normandie, France
        • CHU Sud
      • Rennes, Basse Normandie, France
        • Clinique St Laurent
      • St Gregoire, Basse Normandie, France
        • Chp St Greg
      • St Malo, Basse Normandie, France
        • CH St Malo
    • Bourgogne
      • Chalon S/s, Bourgogne, France
        • CHG William MOREY
      • Dijon, Bourgogne, France
        • Chu Du Bocage
    • Champagne
      • Meaux, Champagne, France
        • Clinique St Faron
      • Reims, Champagne, France
        • CAC Jean Godinot
      • St Quentin, Champagne, France
        • Hopital St Quentin
      • Troyes, Champagne, France
        • Hopital Troyes
    • Haute Normandie
      • Dieppe, Haute Normandie, France
        • CHG Dieppe
      • Evreux, Haute Normandie, France
        • Clinique Pasteur
      • Montivilliers, Haute Normandie, France
        • Ch Jacques Monod
      • Rouen, Haute Normandie, France
        • Centre Frederic Joliot Curie
    • Languedoc
      • Ales, Languedoc, France
        • CHG
      • Beziers, Languedoc, France
        • CHG
      • Carcassonne, Languedoc, France
        • CHG
      • Montpellier, Languedoc, France
        • CHU St Eloi
      • Montpellier, Languedoc, France
        • Clinique Beausoleil
      • Nimes, Languedoc, France
        • CHU Caremeau
      • Perpignan, Languedoc, France
        • Chg St Jean
    • Marseille
      • Aix En Provence, Marseille, France
        • CH du Pays D'Aix
      • Aix En Provence, Marseille, France
        • Clinique Rambot
      • Avignon, Marseille, France
        • Ch Duffaut
    • Massif Central
      • Brive, Massif Central, France
        • Chr Brive
      • Clermont, Massif Central, France
        • Chu Estaing
      • Clermont, Massif Central, France
        • Chu Gabriel Montpied
      • Clermont, Massif Central, France
        • Pole Santé République
      • Montlucon, Massif Central, France
        • Clinique Vitalia Desertines
      • Roanne, Massif Central, France
        • CHR
      • St Etienne, Massif Central, France
        • Icl St Etienne
    • Midi Pyrennees
      • Cahors, Midi Pyrennees, France
        • CHG Cahors
      • St Gaudens, Midi Pyrennees, France
        • CHG St Gaudens
      • Tarbes, Midi Pyrennees, France
        • Clinique de l'Ormeau
      • Toulouse, Midi Pyrennees, France
        • CHU Purpan
      • Toulouse, Midi Pyrennees, France
        • Clinique Pasteur
      • Toulouse, Midi Pyrennees, France
        • Inst. Claudius Regaud
    • Nord
      • Arras, Nord, France
        • Clinique des Bonnettes
      • Boulogne, Nord, France
        • Ch Boulogne-Sur-Mer
      • Lille, Nord, France
        • Centre Oscar Lambret
      • Valenciennes, Nord, France
        • Clinique des Dentellières
    • Paca
      • Draguignan, Paca, France
        • CH de Draguignan
      • Frejus, Paca, France
        • Chi Frejus - St Raphael
      • Frejus, Paca, France
        • CHI de Fréjus
      • GAP, Paca, France
        • CHICAS
      • Hyeres, Paca, France
        • Clinique Ste Marguerite
      • La Seyne Sur Mer, Paca, France
        • Clinique du Cap d'Or
      • Nice, Paca, France
        • Clinique Belvédère
      • Toulon, Paca, France
        • CH Sainte Musse
      • Toulon, Paca, France
        • H.I.A Saint Anne
    • Paris Nord
      • Argenteuil, Paris Nord, France
        • Victor Dubos
      • Osny, Paris Nord, France
        • Clinique Ste Marie
      • Paris, Paris Nord, France
        • Saint Antoine
      • Paris, Paris Nord, France
        • Saint Louis
      • Paris, Paris Nord, France
        • Tenon
      • Pontoise, Paris Nord, France
        • Hpt Rene Dubos
    • Paris Ouest
      • Boulogne, Paris Ouest, France
        • Clinique Porte St Cloud
      • Clichy, Paris Ouest, France
        • BEAUJON
      • Le Chesnay, Paris Ouest, France
        • Hopital Mignot
      • Levallois Perret, Paris Ouest, France
        • Hopital Franco Britannique
      • Maisons Laffitte, Paris Ouest, France
        • Hopital Des Courses
      • Neuilly/seine, Paris Ouest, France
        • HARTMANN
      • St Cloud, Paris Ouest, France
        • Centre René Huguenin
      • Suresnes, Paris Ouest, France
        • Hopital Foch
    • Pays de La Loire
      • Angers, Pays de La Loire, France
        • ICO Angers
      • Cholet, Pays de La Loire, France
        • CH Cholet
      • Le Mans, Pays de La Loire, France
        • CH Le Mans
      • Le Mans, Pays de La Loire, France
        • Victor Hugo
    • Rhone Alpes
      • Aix Les Bains, Rhone Alpes, France
        • Medipole
      • Annecy, Rhone Alpes, France
        • CHRA
      • Bourg en bresse, Rhone Alpes, France
        • Clinique Convert
      • Chambery, Rhone Alpes, France
        • CH Chambéry
      • Grenoble, Rhone Alpes, France
        • CHU Grenoble
      • Valence, Rhone Alpes, France
        • CH Valence

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

Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients presenting with a solid tumor or a malignant hemopathy,
  • Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),
  • Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias

Exclusion Criteria:

  • Patients presenting with a chronic myeloproliferative syndrome,
  • Patients presenting with a myelodysplastic syndrome,
  • Patients showing hypersensitivity to any of the ingredients of Nivestim®,
  • Patients not receiving chemotherapy,
  • Patients who were already included in the study during a previous chemotherapy line

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Curative or prophylactic Nivestim® treatment for FN
Biological: Nivestim®

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
Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months
The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection.
Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months

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
Efficacy of treatment with Nivestim®
Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months
Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction)
Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months
Characteristics of the patients treated with Nivestim® in real-life practice
Time Frame: At Visit 1
Describe the characteristics of the patients treated with Nivestim® in real-life practice,
At Visit 1
Methods of treatment with Nivestim®
Time Frame: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months
Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice.
Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months
Profiles of the physicians participating in the study
Time Frame: At visit 1
Describe the profiles of the physicians participating in the study
At visit 1
General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)
Time Frame: At visit 1
Assess the general practice of these physicians with regard to prescription of G-CSF
At visit 1

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.
Hospira, now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
October 1, 2011

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.
February 1, 2014

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.
February 1, 2014

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).
April 4, 2012

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.
April 9, 2012

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.
April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
July 28, 2015

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.
July 27, 2015

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.
July 1, 2015

More Information

Terms related to this study

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.
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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.

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