Nivestim™ in Treatment of Malignant Diseases

July 23, 2015 updated by: Hospira, now a wholly owned subsidiary of Pfizer

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.

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.

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 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.
386

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

  • Germany
      • Ahaus, Germany, 48683
        • Facharzt für Innere Medizin, Onkologie, Hämatologie
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Hämatologie/Onkologie/Diabetologie
      • Bad Säckingen, Germany, 79713
        • Facharzt für Innere Medizin Hämatologie / Onkologie
      • Berlin, Germany, 10367
        • MediOnko-Institut GbR
      • Berlin, Germany, 13055
        • Onkoplan GmbH/Onkologische Schwerpunkpraxis
      • Chemnitz, Germany, 09117
        • FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie
      • Delitzsch, Germany, 04509
        • MVZ Delitzsch GmbH
      • Dortmund, Germany, 44263
        • Gesellschaft für onkologische Studien Dortmund mbH
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis
      • Düsseldorf, Germany, 40479
        • Gemeinschaftspraxis Haematologie/Medizin Onkologie
      • Eisenach, Germany, 99817
        • Gemeinschaftspraxis
      • Frankfurt/Main, Germany, 60486
        • Krankenhaus Nordwest GmbH Institut für klinische Forschung
      • Garbsen, Germany, 30827
        • Internist - Hämatologe - Onkologe
      • Gütersloh, Germany, 33332
        • Onkodok GmbH
      • Hamburg, Germany, 20095
        • Fachärztin für Allgemeinmedizin
      • Hamburg, Germany, 22765
        • Facharzt für Innere Medizin
      • Hannover, Germany, 30625
        • Internist - Hämatologe - Onkologe
      • Heidenheim, Germany, 89518
        • ODZ-Petersen GmbH
      • Herne, Germany, 44623
        • DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
      • Krefeld, Germany, 47805
        • ZAGO
      • Leipzig, Germany, 04357
        • Pneumologisch/onkologisch/internistisches Studienzentrum
      • Leipzig, Germany, 04107
        • FA f. Frauenheilkunde und Geburtshilfe
      • Lippstadt, Germany, 59555
        • Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin
      • Mainz, Germany, 55131
        • Praxis für Innere Medizin, Hämatologie und Onkologie
      • Minden, Germany, 32429
        • Johannes Esling Klinikum Minden
      • Moers, Germany, 47441
        • OnkoLog Moers GbR
      • Munchen, Germany, 80638
        • Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen
      • München, Germany, 81245
        • Forschungs- und Studiengesellschaft HOPE München GmbH
      • Münster, Germany, 48149
      • Neustadt a. Rbge, Germany, 31535
        • FÄ für Innere Medizin Hämatologie/Internistische Onkologie
      • Neustadt/Sachsen, Germany, 01844
        • Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin
      • Nordhausen, Germany, 99734
        • MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe
      • Nürnberg, Germany, 90491
        • Martha-Maria Krankenhaus gGmbH MVZ Onkologie
      • Oelde, Germany, 59302
        • Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie
      • Oldenburg, Germany, 26121
        • Onkologische Praxis Oldenburg/ Delmenhorst
      • Olpe, Germany, 57462
        • Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
      • Osnabrück, Germany, 49076
      • Remscheid, Germany, 42859
        • Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie
      • Rodgau, Germany, 63110
        • Frauenärzte -Naturheilverfahren-
      • Scheibenberg, Germany, 09481
        • Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie
      • Siegburg, Germany, 53721
        • Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH
      • Soest-Paradiese, Germany, 59494
        • Medizinisches Versorgungszentrum GbR
      • Stralsund, Germany, 18435
        • g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.
      • Stuttgart, Germany, 70190
      • Velbert, Germany, 42551
        • Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie
      • Wiesbaden, Germany, 65191
        • Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)
      • Witten, Germany, 58452
        • FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH
      • Zittau, Germany, 02763
        • FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adult patients with a solid tumour or a malignant haematological tumour

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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)

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

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
Time Frame
Incidence of hospitalisation due to febrile neutropenia and/or infection
Time Frame: 6 months
6 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
Characterisation of patients being treated with Nivestim™
Time Frame: 6 months

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™
6 months
Treatment with Nivestim™ as part of daily routine
Time Frame: 6 months
  • 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.
6 months
Description of the efficacy of treatment with Nivestim™
Time Frame: 6 months

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
6 months
Detailed description of tolerability and safety
Time Frame: 6 months
  • Hospitalisation
  • Adverse events
6 months
Description of the characteristics of the participating physicians
Time Frame: During the study initiation visit
Socio-demographic data (age, gender, field of specialisation, structure of practice, title)
During the study initiation visit
Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)
Time Frame: During the study initiation visit
Criteria for selecting Nivestim™
During the study initiation visit

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.
June 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.
December 1, 2013

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.
December 1, 2013

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).
June 7, 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.
June 25, 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.
June 26, 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 24, 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 23, 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

Keywords

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.
  • VENICE

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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