Chemotherapy Related Anemia

Phase 2

Completed

• Conditions: Anemia; Non-Myeloid Malignancies
• Interventions: Drug: Darbepoetin alfa SC; Drug: Darbepoetin alfa IV

• Registration Number: NCT00035607
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Primary Completion: 2002-12
• Study Completion: 2003-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darbepoetin alfa SC	Darbepoetin alfa SC	-
Darbepoetin alfa IV	Darbepoetin alfa IV	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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