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Study for the Treatment of Anemia in Patients With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy.
This study has been completed.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00148421
  Purpose

Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.


Condition Intervention Phase
Anemia
Drug: Darbepoetin alfa and Epoetin alfa
Phase III

MedlinePlus related topics: Anemia Cancer
Drug Information available for: Epoetin alfa Erythropoietin Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy.

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Reduced incidence of transfusions

Secondary Outcome Measures:
  • Change in hemoglobin concentration

Detailed Description:

The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148421

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

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20030125
Study First Received: June 30, 2005
Last Updated: December 20, 2007
ClinicalTrials.gov Identifier: NCT00148421  
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
Non-myeloid malignancy
Chemotherapy-induced anemia

Study placed in the following topic categories:
Epoetin Alfa
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009