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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117624
First Posted: July 8, 2005
Last Update Posted: December 28, 2007
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.
Information provided by:
Amgen
  Purpose
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 Intervention Phase
Anemia Drug: darbepoetin alfa Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • RBC transfusion during the treatment phase

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

Study Start Date: December 2002
Estimated Study Completion Date: December 2003
  Eligibility

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
Criteria
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
  Contacts and Locations
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
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117624     History of Changes
Other Study ID Numbers: 20020118
First Submitted: June 30, 2005
First Posted: July 8, 2005
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:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics