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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00095277
First received: November 2, 2004
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Anemia
 Drug: Darbepoetin Alfa
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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:
  • Assess efficacy
  • Assess PROs
  • Assess relationship between PROs and hemoglobin concentration
  • Assess safety of dose and frequency

Estimated Enrollment: 220
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095277

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00095277     History of Changes
Other Study ID Numbers: 20030204
Study First Received: November 2, 2004
Last Updated: March 12, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013