Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Subjects with non-myeloid malignancy

• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule

• Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization

• Adequate serum folate and vitamin B12

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Of legal age at the time written informed consent is obtained

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

• Other diagnoses not related to the cancer which can cause anemia

• Inadequate renal and liver function

• Iron deficiency

• Known positive test for HIV infection

• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO

• Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1

• Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1

• Other investigational procedures

• Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)

• 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