Nivestim™ in Treatment of Malignant Diseases

Completed

• Conditions: Primary or Secondary Prophylactic Treatment; Solid Tumour; Malignant Haematological Tumour

• Registration Number: NCT01627990
• Lead Sponsor: Hospira, now a wholly owned subsidiary of Pfizer

Brief 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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hospitalisation due to febrile neutropenia and/or infection	6 months

Secondary Outcome Measures

Name	Time	Method
Characterisation of patients being treated with Nivestim™	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™
Detailed description of tolerability and safety	6 months	* Hospitalisation; * Adverse events
Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)	During the study initiation visit	Criteria for selecting Nivestim™
Treatment with Nivestim™ as part of daily routine	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.
Description of the characteristics of the participating physicians	During the study initiation visit	Socio-demographic data (age, gender, field of specialisation, structure of practice, title)
Description of the efficacy of treatment with Nivestim™	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

Trial Locations

Locations (43)

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; 🇩🇪 Eisenach, Germany

Gemeinschaftspraxis Haematologie/Medizin Onkologie; 🇩🇪 Düsseldorf, Germany

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