Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 30, 2005
Last updated: October 14, 2008
Last verified: August 2008

June 30, 2005
October 14, 2008
January 2004
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Hemoglobin maintenance
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Complete list of historical versions of study NCT00117039 on Archive Site
  • Quality of Life
  • Changes in measures of work productivity and anemia treatment convenience
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A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia
SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy

The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).

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Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anemia
  • Neoplasms
Drug: Aranesp®
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2005
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Inclusion Criteria: - Subjects with non-myeloid malignancy - Anemia (Hgb less than 11.0 g/dL) due to cancer chemotherapy - Receiving chemotherapy and expected to receive at least 8 additional weeks of chemotherapy - Adequate renal function - Adequate liver function Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Unstable cardiac disease - Active bleeding - Active systemic or chronic infection - Severe active chronic inflammatory disease - Other hematologic disorder associated with anemia - Uncontrolled hypertension - Known iron or nutritional deficiency - Known positive test for human immunodeficiency virus (HIV) infection - History of pure red cell aplasia - History of positive antibody response to any erythropoietic agent - Erythropoietin therapy within 4 weeks before screening - RBC transfusions within 2 weeks prior to screening

18 Years and older
Contact information is only displayed when the study is recruiting subjects
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Global Development Leader, Amgen Inc.
Not Provided
Study Director: MD Amgen
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP