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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

705 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia Non-Myeloid Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Darbepoetin alfa 500 mcg - Group A

Group Type EXPERIMENTAL

Darbepoetin alfa - 500mcg

Intervention Type DRUG

Darbepoetin alfa 500mcg Q3W dosing / placebo QW

Darbepoetin alfa 2.25 mcg/kg - Group B

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa - 2.25 mcg/kg

Intervention Type DRUG

Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

Interventions

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Darbepoetin alfa - 2.25 mcg/kg

Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W

Intervention Type DRUG

Darbepoetin alfa - 500mcg

Darbepoetin alfa 500mcg Q3W dosing / placebo QW

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No