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Study Complete
Sponsor ID
20010102

Evaluating Treatment of Anemia in Subjects with Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

Sponsor ID
20010102
Clinicaltrials.gov ID
NCT00111462
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to compare the effect of darbepoetin

alfa administered in a weight based versus fixed dosing for the treatment of

anemia in subjects with non-myeloid malignancies receiving multicycle

chemotherapy.

Additional Study Details

Phase
Phase 2
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
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
    • Show more
  • Anemia of Cancer
  • Cancer - Other
    • Sex
    N/A
    Trial Dates
    Nov 2001 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - Subjects must provide written informed consent
    Exclusion Criteria:
    - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable/uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to any products to be administered - Concerns for subject's compliance