Trial Information
A Randomized, Open-Label, Pilot Study to Evaluate Every Three Week Maintenance Dosing of Darbepoetin Alfa Therapy in Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
Inclusion Criteria:
- Subjects with non-myeloid malignancies - Anemia (screening
hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0
g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic
chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than
or equal to 50% - Serum creatinine concentration less than or equal to 2.0 mg/dL Exclusion
Criteria: - Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening
- Unstable cardiac disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W)
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Institutional Review Board
Study ID:
20020167
NCT ID:
NCT00120705
Start Date:
November 2002
Completion Date:
September 2003
Related Keywords:
- Neoplasms
- Anemia
- anemia
- darbepoetin alfa
- Amgen
- Non-myeloid Malignancies
- Anemia
- Neoplasms