Solid TumorsNCT01574235
Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
An observational study of Solid Tumors and Malignant Hemopathy, run by Hospira, now a wholly owned subsidiary of Pfizer at 87 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Malignant Hemopathy, Chemotherapy-induced Febrile Neutropenia (FN)
- What is being tested?
- Nivestim®
- How many people
- 2,114 participants
- Where
- 87 sitesFrance
- Study dates
- Oct 2011to Feb 2014
- 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 receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
87 sites in 1 country.
87 sites in 1 country
France87 sites
Ch Du Pays D'Aix
Aix-en-Provence, Marseille
Clinique Rambot
Aix-en-Provence, Marseille
MEDIPOLE
Aix-les-Bains, Auvergne-Rhône-Alpes
CHG
Alès, Languedoc
Ico Angers
Angers, Pays de la Loire Region
CHRA
Annecy, Auvergne-Rhône-Alpes
Victor Dubos
Argenteuil, Paris Nord
Clinique des Bonnettes
Arras, Nord
Ch Duffaut
Avignon, Marseille
CHG
Béziers, Languedoc
CH Boulogne-sur-Mer
Boulogne, Nord
Clinique Porte St Cloud
Boulogne, Paris Ouest
Clinique CONVERT
Bourg-en-Bresse, Auvergne-Rhône-Alpes
Chr Brive
Brivé, Massif Central
CHG Cahors
Cahors, Midi Pyrennees
CHG
Carcassonne, Languedoc
Polyclinique Cesson
Cesson, Basse Normandie
CHG William MOREY
Chalon S/s, Bourgogne-Franche-Comté
Ch Chambery
Chambéry, Auvergne-Rhône-Alpes
Ch Cholet
Cholet, Pays de la Loire Region
Chu Estaing
Clermont, Massif Central
Chu Gabriel Montpied
Clermont, Massif Central
Pole Sante Republique
Clermont, Massif Central
BEAUJON
Clichy, Paris Ouest
Hopital Louis Pasteur
Colmar, Alsace
CHG Dieppe
Dieppe, Haute Normandie
CHU du BOCAGE
Dijon, Bourgogne-Franche-Comté
CH de Draguignan
Draguignan, Paca
Hopital Jean Monnet
Épinal, Alsace
Clinique Pasteur
Évreux, Haute Normandie
CHI de Fréjus
Fréjus, Paca
Chi Frejus - St Raphael
Fréjus, Paca
CHICAS
Gap, Paca
Chu Grenoble
Grenoble, Auvergne-Rhône-Alpes
Clinique Ste Marguerite
Hyères, Paca
Clinique du Cap d'Or
La Seyne-sur-Mer, Paca
Hopital Mignot
Le Chesnay, Paris Ouest
Ch Le Mans
Le Mans, Pays de la Loire Region
Victor Hugo
Le Mans, Pays de la Loire Region
Hopital Franco Britannique
Levallois-Perret, Paris Ouest
Centre Oscar Lambret
Lille, Nord
Hopital Des Courses
Maisons-Laffitte, Paris Ouest
Chp Clairval
Marseille, Marseille
Chu Timone
Marseille, Marseille
Fondation Saint Joseph
Marseille, Marseille
Hopital A.Pare
Marseille, Marseille
IPC
Marseille, Marseille
Clinique St Faron
Meaux, Champagne
CH Jacques Monod
Montivilliers, Haute Normandie
Clinique Vitalia Desertines
Montluçon, Massif Central
Chu St Eloi
Montpellier, Languedoc
Clinique Beausoleil
Montpellier, Languedoc
CH Emile Muller
Mulhouse, Alsace
HARTMANN
Neuilly/seine, Paris Ouest
Clinique Belvédère
Nice, Paca
CHU Caremeau
Nîmes, Languedoc
Clinique Ste Marie
Osny, Paris Nord
Saint Antoine
Paris, Paris Nord
Saint Louis
Paris, Paris Nord
TENON
Paris, Paris Nord
Chg St Jean
Perpignan, Languedoc
Hpt Rene Dubos
Pontoise, Paris Nord
Cac Jean Godinot
Reims, Champagne
Chu Rennes
Rennes, Basse Normandie
CHU SUD
Rennes, Basse Normandie
Clinique St Laurent
Rennes, Basse Normandie
CHR
Roanne, Massif Central
Centre frederic joliot curie
Rouen, Haute Normandie
Centre Rene Huguenin
Saint-Cloud, Paris Ouest
Icl St Etienne
Saint-Etienne, Massif Central
CHG St Gaudens
Saint-Gaudens, Midi Pyrennees
Chp St Greg
Saint-Grégoire, Basse Normandie
Hopital St Quentin
Saint-Quentin, Champagne
Ch St Malo
St-Malo, Basse Normandie
CAC Paul Strauss
Strasbourg, Alsace
Chu Hopital Civil
Strasbourg, Alsace
STE ANNE
Strasbourg, Alsace
Hopital Foch
Suresnes, Paris Ouest
Clinique de l'Ormeau
Tarbes, Midi Pyrennees
CH Sainte Musse
Toulon, Paca
H.I.A Saint Anne
Toulon, Paca
CHU Purpan
Toulouse, Midi Pyrennees
Clinique Pasteur
Toulouse, Midi Pyrennees
Inst. Claudius Regaud
Toulouse, Midi Pyrennees
Hopital Troyes
Troyes, Champagne
Ch Valence
Valence, Auvergne-Rhône-Alpes
Clinique des Dentellieres
Valenciennes, Nord
About this study
Official title: 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.
- Being tested
- Nivestim®
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivestim®Biological
| Study group | Role | What they receive |
|---|---|---|
| Curative or prophylactic Nivestim® treatment for FN | Not described Receives: Biological: Nivestim® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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 outcomes (5)
Efficacy of treatment with Nivestim®
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)
Measured: 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
Describe the characteristics of the patients treated with Nivestim® in real-life practice,
Measured: At Visit 1
Methods of treatment with Nivestim®
Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice.
Measured: 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
Describe the profiles of the physicians participating in the study
Measured: At visit 1
General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)
Assess the general practice of these physicians with regard to prescription of G-CSF
Measured: At visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- 2,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574235
- Sponsor's protocol ID
- NEXT
- Status last verified
- Jul 2015
- First submitted
- 4 Apr 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.
PubMed 24237790
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice
- ClinicalTrials.gov ID
- NCT01574235
- Acronym / sponsor ID
- NEXT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,114 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Apr 2012 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curative or prophylactic Nivestim® treatment for FN | – | Biological: Nivestim® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving chemotherapy and treated with Nivestim® to prevent or reduce chemotherapy-induced febrile neutropenia.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivestim® | Biological | Curative or prophylactic Nivestim® treatment for FN |
Primary outcome
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.
5 secondary outcomes
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
Characteristics of the patients treated with Nivestim® in real-life practice
Time frame: 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
Profiles of the physicians participating in the study
Time frame: At visit 1
General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)
Time frame: At visit 1
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 28 Jul 2015.
- Derived from this study: PubMed 24237790Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.
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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.
87 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors and Malignant Hemopathy, run by Hospira, now a wholly owned subsidiary of Pfizer at 87 sites in France.
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 4 inclusion and 5 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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in France. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01574235, which also lists 1 linked publication.
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 28 Jul 2015.