A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anemia
Both
Anemia
Trial Information
A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy
Inclusion Criteria:
- Non-myeloid malignancy - At least 12 additional weeks of cycliccytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or
chemotherapy-associated anemia Exclusion Criteria: - Known history of seizure disorder -
Known primary hematologic disorder, which could cause anemia, other than a non-myeloid
malignancy - Unstable or uncontrolled disease/condition, related to or affecting cardiac
function - Clinically significant inflammatory disease - Inadequate renal and/or liver
function
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:
RBC transfusion during the treatment phase
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
20020118
NCT ID:
NCT00117624
Start Date:
December 2002
Completion Date:
December 2003
Related Keywords:
- Anemia
- Non-myeloid malignancy
- Darbepoetin alfa
- Clinical Trial
- Anemia
- Neoplasms
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