Solid TumourNCT01627990
Nivestim™ in Treatment of Malignant Diseases
An observational study of Solid Tumour and Malignant Haematological Tumour, run by Hospira, now a wholly owned subsidiary of Pfizer at 48 sites in Germany.
Trial summary
The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumour, Malignant Haematological Tumour, Primary or Secondary Prophylactic Treatment
- How many people
- 386 participants
- Where
- 48 sitesGermany
- Study dates
- Jun 2011to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and adult patients with a solid tumour or a malignant haematological tumour
Who may be able to join
- No age limit
- Declaration of informed consent signed by patient or legal guardian
- Patients with a solid tumour or with a malignant haematological tumour
- Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
- Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).
Who cannot join
- Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS)
- Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
- Patients not undergoing chemotherapy
- Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Germany48 sites
Facharzt für Innere Medizin, Onkologie, Hämatologie
Ahaus, 48683
Studienzentrum Hämatologie/Onkologie/Diabetologie
Aschaffenburg, 63739
Facharzt für Innere Medizin Hämatologie / Onkologie
Bad Säckingen, 79713
MediOnko-Institut GbR
Berlin, 10367
Onkoplan GmbH/Onkologische Schwerpunkpraxis
Berlin, 13055
FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie
Chemnitz, 09117
MVZ Delitzsch GmbH
Delitzsch, 04509
Gesellschaft für onkologische Studien Dortmund mbH
Dortmund, 44263
Gemeinschaftspraxis
Dresden, 01307
Gemeinschaftspraxis Haematologie/Medizin Onkologie
Düsseldorf, 40479
Gemeinschaftspraxis
Eisenach, 99817
Krankenhaus Nordwest GmbH Institut für klinische Forschung
Frankfurt am Main, 60486
Internist - Hämatologe - Onkologe
Garbsen, 30827
Onkodok GmbH
Gütersloh, 33332
Fachärztin für Allgemeinmedizin
Hamburg, 20095
Facharzt für innere Medizin
Hamburg, 22765
Internist - Hämatologe - Onkologe
Hanover, 30625
ODZ-Petersen GmbH
Heidenheim, 89518
DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
Herne, 44623
ZAGO
Krefeld, 47805
FA f. Frauenheilkunde und Geburtshilfe
Leipzig, 04107
Pneumologisch/onkologisch/internistisches Studienzentrum
Leipzig, 04357
Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin
Lippstadt, 59555
Praxis für Innere Medizin, Hämatologie und Onkologie
Mainz, 55131
Johannes Esling Klinikum Minden
Minden, 32429
OnkoLog Moers GbR
Moers, 47441
Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen
München, 80638
Forschungs- und Studiengesellschaft HOPE München GmbH
München, 81245
Study site
Münster, 48149
FÄ für Innere Medizin Hämatologie/Internistische Onkologie
Neustadt A. Rbge, 31535
Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin
Neustadt/Sachsen, 01844
MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe
Nordhausen, 99734
Martha-Maria Krankenhaus gGmbH MVZ Onkologie
Nuremberg, 90491
Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
Oelde, 59302
Onkologische Praxis Oldenburg/ Delmenhorst
Oldenburg, 26121
Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
Olpe, 57462
Study site
Osnabrück, 49076
Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
Remscheid, 42859
Frauenärzte -Naturheilverfahren-
Rodgau, 63110
Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie
Scheibenberg, 09481
Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
Siegburg, 53721
Medizinisches Versorgungszentrum GbR
Soest-Paradiese, 59494
g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
Stralsund, 18435
Study site
Stuttgart, 70190
Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
Velbert, 42551
Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)
Wiesbaden, 65191
FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH
Witten, 58452
FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin
Zittau, 02763
About this study
Official title: The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.
Read the detailed description
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).
- Conditions
- Solid Tumour, Malignant Haematological Tumour, Primary or Secondary Prophylactic Treatment
- Keywords
- cytotoxic chemotherapy, G-CSF, Solid tumour, Malignant haematological tumour
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospitalisation due to febrile neutropenia and/or infection
Measured: 6 months
Secondary outcomes (6)
Characterisation of patients being treated with Nivestim™
Characterisation of patient based on:
- Socio-demographic data
- previous medical history (Surgical and therapeutic)
- Tumour data
- Chemotherapy data
- Clinical and laboratory data preceding treatment with Nivestim™
Measured: 6 months
Treatment with Nivestim™ as part of daily routine
- Therapeutic indication
- Dosage and mode of administration
- Duration of treatment (planned and carried through)
- Delay in start of treatment since last chemotherapy for purposes of prophylaxis
- Absolute Neutrophil Count (ANC) during study.
Measured: 6 months
Description of the efficacy of treatment with Nivestim™
Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters:
- Duration of neutropenia
- Incidence of febrile neutropenia
- Frequency of infection
- Delay in chemotherapy cycles due to neutropenia
- Reduction in chemotherapy doses due to neutropenia
- Assessment of patient
Measured: 6 months
Detailed description of tolerability and safety
- Hospitalisation
- Adverse events
Measured: 6 months
Description of the characteristics of the participating physicians
Socio-demographic data (age, gender, field of specialisation, structure of practice, title)
Measured: During the study initiation visit
Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)
Criteria for selecting Nivestim™
Measured: During the study initiation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumourStudies 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
- 386 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
- NCT01627990
- Sponsor's protocol ID
- VENICE
- Status last verified
- Jul 2015
- First submitted
- 7 Jun 2012
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fruehauf S, Otremba B, Stotzer O, Rudolph C. Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study. Adv Ther. 2016 Nov;33(11):1983-2000. doi: 10.1007/s12325-016-0419-1. Epub 2016 Oct 14.
PubMed 27743353Kamioner 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 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
- ClinicalTrials.gov ID
- NCT01627990
- Acronym / sponsor ID
- VENICE
- Conditions
- Solid Tumour, Malignant Haematological Tumour, Primary or Secondary Prophylactic Treatment
- Keywords
- cytotoxic chemotherapy, G-CSF, Solid tumour, Malignant haematological tumour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jun 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 purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.
Detailed description
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adult patients with a solid tumour or a malignant haematological tumour
Key inclusion criteria (5 listed)
- No age limit
- Declaration of informed consent signed by patient or legal guardian
- Patients with a solid tumour or with a malignant haematological tumour
- Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
- Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).
Key exclusion criteria (4 listed)
- Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS)
- Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
- Patients not undergoing chemotherapy
- Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hospitalisation due to febrile neutropenia and/or infection
Time frame: 6 months
6 secondary outcomes
Characterisation of patients being treated with Nivestim™
Time frame: 6 months
Treatment with Nivestim™ as part of daily routine
Time frame: 6 months
Description of the efficacy of treatment with Nivestim™
Time frame: 6 months
Detailed description of tolerability and safety
Time frame: 6 months
Description of the characteristics of the participating physicians
Time frame: During the study initiation visit
Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)
Time frame: During the study initiation visit
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 24 Jul 2015.
- Derived from this study: PubMed 27743353Fruehauf S, Otremba B, Stotzer O, Rudolph C. Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study. Adv Ther. 2016 Nov;33(11):1983-2000. doi: 10.1007/s12325-016-0419-1. Epub 2016 Oct 14.
- 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.
48 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 Tumour and Malignant Haematological Tumour, run by Hospira, now a wholly owned subsidiary of Pfizer at 48 sites in Germany.
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 5 inclusion and 4 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 24 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 48 sites in Germany. 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?
Incidence of hospitalisation due to febrile neutropenia and/or infection (time frame: 6 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 NCT01627990, which also lists 2 linked publications.
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 24 Jul 2015.