Status:
COMPLETED
FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy
Lead Sponsor:
Amgen
Conditions:
Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosup...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
2252 Patients enrolled
Trial Details
Trial ID
NCT00125723
Start Date
May 1 2004
End Date
December 1 2005
Last Update
December 23 2010
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