A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

Amgen0 sites120 target enrollmentDecember 2001

ConditionsAnemia Non-Myeloid Malignancies

InterventionsDarbepoetin alfa SC Darbepoetin alfa IV

DrugsDarbepoetin alfa SC Darbepoetin alfa IV

Overview

Phase: Phase 2
Intervention: Darbepoetin alfa SC
Conditions: Anemia
Sponsor: Amgen
Enrollment: 120
Primary Endpoint: Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

December 2001

End Date

April 2003

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Darbepoetin alfa SC

Intervention: Darbepoetin alfa SC

Darbepoetin alfa IV

Intervention: Darbepoetin alfa IV

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration(throughout study)
Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP(from baseline to week 7 and from week 7 to EOTP)
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period(during the treatment period)
Time to and percentage of subjects with a hemoglobin response during the treatment period(during the treatment period)
Percentage of subjects who exceed the hemoglobin threshold(throughout study)
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events(throughout study)
Incidence, if any, of neutralizing antibody formation to darbepoetin alfa(throughout study)