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Study Complete
Sponsor ID
20020118

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects with a Non-myeloid Malignancy

Sponsor ID
20020118
Clinicaltrials.gov ID
NCT00117624
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
N/A
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
N/A
Condition
  • Anemia
    • Sex
    N/A
    Trial Dates
    Dec 2002 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Non-myeloid malignancy - At least 12 additional weeks of cyclic cytotoxic 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