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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00117624
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : December 28, 2007
Information provided by:

Brief Summary:
The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.

Condition or disease Intervention/treatment Phase
Anemia Drug: darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy
Study Start Date : December 2002
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Primary Outcome Measures :
  1. RBC transfusion during the treatment phase

Secondary Outcome Measures :
  1. The time to hemoglobin response during the treatment phase
  2. The FACT-Fatigue score profile over time
  3. The change in hemoglobin
  4. Incidence and severity of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Non-myeloid malignancy - At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or chemotherapy-associated anemia 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117624

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117624     History of Changes
Other Study ID Numbers: 20020118
First Posted: July 8, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Amgen:
Non-myeloid malignancy
Darbepoetin alfa
Clinical Trial

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa