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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00118638

Collaborator

(none)

705

Enrollment

Arms

10.1

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Non-Myeloid Malignancies	Drug: Darbepoetin alfa - 2.25 mcg/kg Drug: Darbepoetin alfa - 500mcg	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

705 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) [from week 5 to EOTP]

Secondary Outcome Measures

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 FACT-G Physical Well-being subscale from baseline to EOTP [from baseline to EOTP]
Change in hemoglobin from baseline to EOTP [from baseline to EOTP]
Change in FACT-Fatigue subscale score from baseline to EOTP [from baseline to EOTP]
Change in FACT-G total score from baseline to EOTP [from baseline to EOTP]
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]
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 number of caregiver hours 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]
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]
Incidence of a confirmed antibody formation to darbepoetin alfa [throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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