Nivestim™ in Treatment of Malignant Diseases

Solid Tumour Clinical Trial

Official title:

The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627990
• Other study ID #: VENICE
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: July 23, 2015
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malignant Haematological Tumour
• Primary or Secondary Prophylactic Treatment
• Solid Tumour

Locations

Country	Name	City	State
Germany	Facharzt für Innere Medizin, Onkologie, Hämatologie	Ahaus
Germany	Studienzentrum Hämatologie/Onkologie/Diabetologie	Aschaffenburg
Germany	Facharzt für Innere Medizin Hämatologie / Onkologie	Bad Säckingen
Germany	MediOnko-Institut GbR	Berlin
Germany	Onkoplan GmbH/Onkologische Schwerpunkpraxis	Berlin
Germany	FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie	Chemnitz
Germany	MVZ Delitzsch GmbH	Delitzsch
Germany	Gesellschaft für onkologische Studien Dortmund mbH	Dortmund
Germany	Gemeinschaftspraxis	Dresden
Germany	Gemeinschaftspraxis Haematologie/Medizin Onkologie	Düsseldorf
Germany	Gemeinschaftspraxis	Eisenach
Germany	Krankenhaus Nordwest GmbH Institut für klinische Forschung	Frankfurt/Main
Germany	Internist - Hämatologe - Onkologe	Garbsen
Germany	Onkodok GmbH	Gütersloh
Germany	Facharzt für innere Medizin	Hamburg
Germany	Fachärztin für Allgemeinmedizin	Hamburg
Germany	Internist - Hämatologe - Onkologe	Hannover
Germany	ODZ-Petersen GmbH	Heidenheim
Germany	DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG	Herne
Germany	ZAGO	Krefeld
Germany	FA f. Frauenheilkunde und Geburtshilfe	Leipzig
Germany	Pneumologisch/onkologisch/internistisches Studienzentrum	Leipzig
Germany	Fachübergreifende Gemeinschaftspraxis Innere Medizin, Hämatologie, Onkologie, Tumortherapie, Palliativmedizin	Lippstadt
Germany	Praxis für Innere Medizin, Hämatologie und Onkologie	Mainz
Germany	Johannes Esling Klinikum Minden	Minden
Germany	OnkoLog Moers GbR	Moers
Germany	Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie - Bluttransfusionswesen	Munchen
Germany	Forschungs- und Studiengesellschaft HOPE München GmbH	München
Germany	FÄ für Innere Medizin Hämatologie/Internistische Onkologie	Neustadt a. Rbge
Germany	Facharzt für Innere Medizin - Medikamentöse Tumortherapie - Palliativmedizin	Neustadt/Sachsen
Germany	MVZ Nordhausen gGmbH/ FA für Frauenheilkunde und Geburtshilfe	Nordhausen
Germany	Martha-Maria Krankenhaus gGmbH MVZ Onkologie	Nürnberg
Germany	Fachärztin für Innere Medizin Hämatologie u. Internistische Onkologie	Oelde
Germany	Onkologische Praxis Oldenburg/ Delmenhorst	Oldenburg
Germany	Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis	Olpe
Germany	Facharzt für Innere Medizin - Hämatologie - Onkologie - Medikamentöse Tumortherapie	Remscheid
Germany	Frauenärzte -Naturheilverfahren-	Rodgau
Germany	Facharzt für Fraueneheilkunde und Geburtshilfe Gynäkologische Onkologie	Scheibenberg
Germany	Onkol. Managementgesellschaft Bonn/Rhein-Sieg/Ahr mbH	Siegburg
Germany	Medizinisches Versorgungszentrum GbR	Soest-Paradiese
Germany	g.SUND Gyn. Kompetenzzentrum FA f. Frauenheilkunde & Geburtshilfe SP Gynäkologie Onkologie operative Gyn./ med. Tumortherapie/ Palliativmed.	Stralsund
Germany	Fachärzte für Innere Medizin -Hämatologie und Internistische Onkologie	Velbert
Germany	Gesellschaft zur Förderung von Wissenschaft und Qualitätssicherung in der ambulanten Onkologie (GFWQ)	Wiesbaden
Germany	FA f. Frauenheilkunde u. Geburtshilfe Marien-Hospital Witten gGmbH	Witten
Germany	FA für innere Medizin/Hämatologie und Int. Onkologie/Palliativmedizin	Zittau

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hospitalisation due to febrile neutropenia and/or infection		6 months	Yes
Secondary	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™	6 months	Yes
Secondary	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.	6 months	Yes
Secondary	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	6 months	No
Secondary	Detailed description of tolerability and safety	Hospitalisation; Adverse events	6 months	Yes
Secondary	Description of the characteristics of the participating physicians	Socio-demographic data (age, gender, field of specialisation, structure of practice, title)	During the study initiation visit	No
Secondary	Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)	Criteria for selecting Nivestim™	During the study initiation visit	Yes