FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy
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Purpose
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 myelosuppressive chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Neutropenia |
Other: PI Discretion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-label, Phase 4 Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy |
- dose delays and dose reductions and neutropenic events [ Time Frame: during treatment ] [ Designated as safety issue: No ]
| Enrollment: | 2252 |
| Study Start Date: | May 2004 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No Intervention
NONE
|
Other: PI Discretion
PI Discretion
|
|
Intervention
PI Discretion
|
Other: PI Discretion
PI Discretion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00125723 History of Changes |
| Other Study ID Numbers: | 20030218 |
| Study First Received: | July 29, 2005 |
| Last Updated: | December 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Amgen:
|
Phase 4 Clinical Trial Chemotherapy Neulasta® Oncology Malignancy |
Additional relevant MeSH terms:
|
Neutropenia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013