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

Amgen

Status and phase: Completed; Phase 3

Conditions: Anemia; Non-Myeloid Malignancies

Treatments: Drug: Darbepoetin alfa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110955

20030232

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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391 participants in 2 patient groups, including a placebo group

Darbepoetin alfa - Group A

Experimental group

Treatment:

Drug: Darbepoetin alfa

Placebo- Group B

Placebo Comparator group

Treatment:

Drug: Placebo