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Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT00120705
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Amgen

Brief Summary:
The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).

Condition or disease Intervention/treatment Phase
Neoplasms Anemia Drug: darbepoetin alfa Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Pilot Study to Evaluate Every Three Week Maintenance Dosing of Darbepoetin Alfa Therapy in Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
Study Start Date : November 2002
Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W)

Secondary Outcome Measures :
  1. Assess safety profile of subjects treated with darbepoetin alfa


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: - Subjects with non-myeloid malignancies - Anemia (screening hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0 g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than or equal to 50% - Serum creatinine concentration less than or equal to 2.0 mg/dL Exclusion Criteria: - Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening - Unstable cardiac disease

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): NCT00120705


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00120705     History of Changes
Other Study ID Numbers: 20020167
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Amgen:
anemia
darbepoetin alfa
Amgen
Non-myeloid Malignancies

Additional relevant MeSH terms:
Neoplasms
Darbepoetin alfa
Hematinics