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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Non-Myeloid Malignancies
• Intervention / Treatment: Drug: Darbepoetin alfa; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darbepoetin alfa - Group A	Drug: Darbepoetin alfa; Q3W 300 mcg darbepoetin alfa
Placebo Comparator: Placebo- Group B	Drug: Placebo; Q3W dosing of placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164.

Helpful Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• FDA-approved Drug Labeling
• To access clinical trial results information click on this link

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: May 16, 2005
• First Submitted That Met QC Criteria: May 16, 2005
• First Posted (Estimate): May 17, 2005

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Non-myeloid malignancy; Chemotherapy-induced anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Neoplasms; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 20030232