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

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-04-30

Brief Summary

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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.

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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 - Group A

Group Type EXPERIMENTAL

Darbepoetin alfa

Intervention Type DRUG

Q3W 300 mcg darbepoetin alfa

Placebo- Group B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Q3W dosing of placebo

Interventions

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Darbepoetin alfa

Q3W 300 mcg darbepoetin alfa

Intervention Type DRUG

Placebo

Q3W dosing of placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No