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

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ClinicalTrials.gov Identifier: NCT00095277
Recruitment Status : Completed
First Posted : November 3, 2004
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:
Amgen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Darbepoetin Alfa Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.

Secondary Outcome Measures :
  1. Assess efficacy
  2. Assess PROs
  3. Assess relationship between PROs and hemoglobin concentration
  4. Assess safety of dose and frequency

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00095277


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00095277     History of Changes
Other Study ID Numbers: 20030204
First Posted: November 3, 2004    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by Amgen:
non-myeloid malignancies
myeloma
Anemia of Cancer

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics