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

Phase 2

Completed

• Conditions: Anemia; Non-Myeloid Malignancies; Cancer

• Registration Number: NCT00111462
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-20
• Study First Submitted QC: 2005-05-20
• Study First Posted: 2005-05-23
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline

Secondary Outcome Measures

Name	Time	Method
Time to and percentage of subjects with a hemoglobin response
Time to and percentage of subjects with hemoglobin correction
Hemoglobin concentration and change in hemoglobin concentration from baseline
Time to first RBC transfusion and percentage of subjects receiving a RBC transfusion