A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

A Randomized, Double Blind, Active-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 evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Study Overview

• Status: Completed
• Conditions: Anemia; Non-Myeloid Malignancies
• Intervention / Treatment: Drug: Darbepoetin alfa - 500mcg; Drug: Darbepoetin alfa - 2.25 mcg/kg

• Study Type: Interventional
• Enrollment (Actual): 705
• 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:

• Non-myeloid malignancy
• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
• Eastern Cooperative Oncology Group performance status of 0-2
• Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
• Of legal age at the time written informed consent is obtained

Exclusion Criteria:

• Known history of seizure disorder
• Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
• Unstable or uncontrolled disease/condition, related to or affecting cardiac function
• Clinically significant inflammatory disease
• Inadequate renal and/or liver function
• Known positive HIV test
• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
• Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1
• Other investigational procedures
• Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
• Pregnant or breast feeding
• Not using adequate contraceptive precautions
• Known sensitivity to any of the products to be administered during dosing
• Previously randomized in this study
• Concerns for subject's compliance with protocol procedures

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 500 mcg - Group A	Drug: Darbepoetin alfa - 500mcg; Darbepoetin alfa 500mcg Q3W dosing / placebo QW
Active Comparator: Darbepoetin alfa 2.25 mcg/kg - Group B	Drug: Darbepoetin alfa - 2.25 mcg/kg; Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)	from week 5 to EOTP

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP	from week 5 to EOTP
Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP	from week 1 (day 1) to EOTP
Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP	from week 1 to EOTP
Change in hemoglobin from baseline to EOTP	from baseline to EOTP
Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences	throughout study

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus >/= 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13.
• Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84. doi: 10.1093/jnci/djj053.
• Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311. doi: 10.1186/1471-2407-9-311.

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: March 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: June 30, 2005
• First Submitted That Met QC Criteria: June 30, 2005
• First Posted (Estimate): July 12, 2005

Study Record Updates

• Last Update Posted (Estimate): April 29, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Darbepoetin alfa; Clinical Trial; Non-myeloid malignancy
• Additional Relevant MeSH Terms: Hematologic Diseases; Neoplasms; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 20030231