A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Amgen0 sites391 target enrollmentFebruary 2004

ConditionsAnemia Non-Myeloid Malignancies

InterventionsDarbepoetin alfa Placebo

DrugsDarbepoetin alfa Placebo

Overview

Phase: Phase 3
Intervention: Darbepoetin alfa
Conditions: Anemia
Sponsor: Amgen
Enrollment: 391
Primary Endpoint: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

April 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Eligibility 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

Arms & Interventions

Darbepoetin alfa - Group A

Intervention: Darbepoetin alfa

Placebo- Group B

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)

Time Frame: from week 5 to EOTP

Secondary Outcomes

Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP(from week 5 to EOTP)
Number of RBC transfusions from week 5 to EOTP(from week 5 to EOTP)
Change in FACT-Fatigue subscale score from baseline to EOTP(from baseline to EOTP)
Change in FACT-G Physical Well-being subscale from baseline to EOTP(from baseline to EOTP)
Incidence and severity of adverse events(throughout study)
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study(at any time on study)
Change in FACT-G total score from baseline to EOTP(from baseline to EOTP)
Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences(throughout study)
Change in EQ-5D Thermometer from baseline to EOTP(from baseline to EOTP)
Change in BSI Anxiety scale score from baseline to EOTP(from baseline to EOTP)
Change in BSI Depression scale score from baseline to EOTP(from baseline to EOTP)
Change in number of caregiver hours from baseline to EOTP(from baseline to EOTP)
Incidence of a confirmed antibody formation to darbepoetin alfa(throughout study)