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A Multicenter, Open-label, Phase 4 Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Neutropenia

Thank you

Trial Information

A Multicenter, Open-label, Phase 4 Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy


Inclusion Criteria:

- Pathologically confirmed diagnosis of the following malignancies:
breast, non-Hodgkin's lymphoma (NHL), Hodgkin's disease, ovarian, colorectal, lung or
other - Planned administration of a new myelosuppressive every 14 (q14), q21, or q28 day
chemotherapy - Written informed consent for participation in the study before any
study-specific procedures are performed, including screening and registration Exclusion
Criteria: - Planned concomitant therapeutic radiation - Diagnosis of acute or chronic
leukemia or myelodysplastic syndrome - Prior stem-cell transplantation (includes
bone-marrow transplantation) - Medical diagnosis of chronic neutropenia of any cause not
related to cancer - Current cytotoxic, biologic, or immunologic therapy for unrelated
conditions - Subject has active infection requiring treatment - Known HIV-positive
subjects - Subject of child-bearing potential is evidently pregnant (e.g., positive HCG
test) or is breast feeding - Subject of child-bearing potential is not using adequate
contraceptive precautions - Known sensitivity to E. coli derived drug products (e.g.,
filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® growth hormone, INTRON A®) - Any
psychiatric, addictive or other kind of disorder which compromises the ability of the
subject to give written informed consent and/or to comply with study protocol procedures -
Subject is currently enrolled in, or has not yet completed at least 30 days since ending
another device or drug trial(s) or is receiving, or plans to receive, other
investigational agent(s) not approved by the Food and Drug Administration (FDA)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

dose delays and dose reductions and neutropenic events

Outcome Time Frame:

during treatment

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20030218

NCT ID:

NCT00125723

Start Date:

May 2004

Completion Date:

December 2005

Related Keywords:

  • Neutropenia
  • Phase 4 Clinical Trial
  • Chemotherapy
  • Neulasta®
  • Oncology
  • Malignancy
  • Neutropenia

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