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Study Complete
Sponsor ID
20020167

Treatment for Anemic Subjects with Non-Myeloid Malignancies Receiving Chemotherapy

Sponsor ID
20020167
Clinicaltrials.gov ID
NCT00120705
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is 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).

Additional Study Details

Phase
Phase 2
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
204
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Solid Tumor
  • Anemia
    • Sex
    All
    Trial Dates
    Nov 2002 - N/A
    Inclusion and Exclusion Criteria
    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