A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer
Inclusion Criteria
Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on
chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to
2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function -
Written informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20030204
NCT ID:
NCT00095277
Start Date:
October 2004
Completion Date:
Related Keywords:
- Anemia
- non-myeloid malignancies
- myeloma
- Anemia of Cancer
- Anemia
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