CompletedPhase 2

Chemotherapy Related Anemia

120 participantsStarted 2001-12

Plain-language summary

This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Diagnosed with a non-myeloid malignancy * Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug * Screening hemoglobin concentration less than or equal to 11.0g/dL * ECOG performance status of 0 to 2 * Adequate renal and liver function Exclusion Criteria: * History of seizure disorder * Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1 * More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1

What they're measuring

Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)

Timeframe: from baseline to the end of treatment period (EOTP)

Trial details

NCT IDNCT00035607

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2002-12

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