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Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy
This study has been completed.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00111462
  Purpose

The purpose of this study is to compare the effect of darbepoetin alfa administered in a weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.


Condition Intervention Phase
Anemia
Non-Myeloid Malignancies
Cancer
Drug: Darbepoetin alfa
Phase II

MedlinePlus related topics: Anemia Cancer
Drug Information available for: Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Factorial Assignment
Official Title: A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) Using Fixed and Weight-Based Dosing for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline

Secondary Outcome Measures:
  • Time to and percentage of subjects with a hemoglobin response
  • Time to and percentage of subjects with hemoglobin correction
  • Hemoglobin concentration and change in hemoglobin concentration from baseline
  • Time to first RBC transfusion and percentage of subjects receiving a RBC transfusion

  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 - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - 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 - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic 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 any products to be administered - Concerns for subject's compliance

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111462

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

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
ClinicalStudyResults website - Results posting for study 20010102  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20010102
Study First Received: May 20, 2005
Last Updated: May 15, 2008
ClinicalTrials.gov Identifier: NCT00111462  
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
non-myeloid malignancy
chemotherapy-induced anemia

Study placed in the following topic categories:
Body Weight
Hematologic Diseases
Darbepoetin alfa
Anemia

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

ClinicalTrials.gov processed this record on January 16, 2009