Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

NCT ID: NCT00095277

Last Updated: 2009-03-13

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

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Darbepoetin Alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Gordon D, Nichols G, Ben-Jacob A, Tomita D, Lillie T, Miller C. Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study. Oncologist. 2008 Jun;13(6):715-24. doi: 10.1634/theoncologist.2007-0241.

Reference Type RESULT
PMID: 18586927 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://www.aranesp.com/

FDA-approved Drug Labeling

Other Identifiers

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20030204

Identifier Type: -

Identifier Source: org_study_id

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