Trial document

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Trial Description

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International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

This international, prospective, observational, open-label, pharmaco-epidemiologic study
observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are
receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe
the patient population at risk for FN and treated prophylactically with filgrastim
biosimilar, to describe prophylaxis patterns involving filgrastim biosimilar, and to
evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy
delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify
patient cohorts who are vulnerable to poor response to FN prophylaxis and experience
break-through episodes of FN, understand the differences between prophylaxis responders and
non-responders, and describe the degree to which prophylaxis of FN is in congruence with
guideline recommendations.

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Brief Summary in Scientific Language


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Organizational Data

  •   DRKS00004140
  •   2012/11/21
  •   2011/08/30
  •   no
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Secondary IDs

  •   NCT01459653  (
  •   Monitor-GCSF, EP-502  (Sandoz)
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Health Condition or Problem studied

  •   Febrile Neutropenia
  •   Cancer
  •   Breast Cancer
  •   Ovarian Cancer
  •   Lung Cancer
  •   Prostate Cancer
  •   Multiple Myeloma
  •   Bladder Cancer
  •   B-cell Lymphoma
  •   D70 -  Agranulocytosis
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Interventions/Observational Groups

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  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Absolute neutrophil count (ANC); time frame: 6 months, 6 cycles of chemotharapy; Describe intraindividual changes in ANC.

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Secondary Outcome

- Cohort identification and differentiation; time frame: 6 months, 6 cycles of chemotherapy; Patient profiles based on medical history, concomitant comorbid conditions and current clinical status.
- Nonresponder analyses; time frame: 6 months, 6 cycles of chemotherapy; Patient- and center-level variables between patients who had:
chemotherapy dose delays or reductions,
surgery delays or cancellations, and
radiotherapy delays, dose reductions or cancellations vs no such events and
patients who died vs. survived during the course of prophylaxis with filgrastim biosimilar in all patients and those with break-through FN episodes.

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Countries of Recruitment

  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Poland
  •   Romania
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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  •   2010/03/31
  •   1500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Male or female adults (age > / = 18 years)

- Diagnosed with one of the following types and stages of tumors: stage III or IV
breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage
III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large
B-cell lymphoma; multiple myeloma.

- Planned to receive primary prophylaxis with filgrastim biosimilar at the first cycle
of chemotherapy (regardless of line of chemotherapy); or receiving secondary
prophylaxis with filgrastim biosimilar irrespective of chemotherapy cycle.

- Treated with commercially available filgrastim biosimilar per physician's best
clinical judgment and per current European filgrastim biosimilar label.

- Female patients must be either post-menopausal for one year or surgically sterile or
using effective contraceptive methods such as barrier method with spermicide or an
intra-uterine device. Oral contraceptive use is allowed.

- Informed written consent to participate in the study by patients or their legal

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Exclusion Criteria

- Patients with myeloid malignancies, with the exception of multiple myeloma.

- Sensitivity to filgrastim biosimilar or any other CSF.

- Hypersensitivity to E. coli-derived proteins.

- Radiotherapy to ≥ 20% of total body bone.

- Infection within two weeks of starting current line of chemotherapy.

- Patients with several medical condition(s) that in view of the investigator prohibits
participation in the study.

- Patients with willfully negligent nonadherence to their cancer treatment.

- Use of any investigational agent in the 30 days prior to enrollment.

- Women of childbearing potential not using the contraception method(s) described

- Women who are breastfeeding.

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  • start of 1:1-Block address primary-sponsor
    • Sandoz
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    • Sandoz
    • Matthew Turner, PhD 
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    • Sandoz
    • Matthew Turner, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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  •   Recruiting complete, follow-up complete
  •   2013/08/01
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Trial Publications, Results and other Documents

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The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.