Status:
COMPLETED
Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy
Lead Sponsor:
Amgen
Conditions:
Cancer
Non-Myeloid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to rec...
Eligibility Criteria
Inclusion
- Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
- Anemia (hemoglobin \[hgb\] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
- Karnofsky performance status of greater than or equal to 50%
- Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL
Exclusion
- Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
- Hematologic disorder previously associated with anemia
- Active bleeding
- Iron deficiency
- Received erythropoietic therapy within 14 days prior to randomization
- Unstable cardiac disease
- Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
- Known positive antibody response to any erythropoietic agent
- Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
- Pregnant or breast feeding
- Red blood cell (RBC) transfusion within 4 weeks of screening
- Known hypersensitivity to any recombinant mammalian-derived product
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT00111137
Start Date
February 1 2003
End Date
April 1 2004
Last Update
February 28 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.