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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117039
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : October 15, 2008
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Anemia Neoplasms Drug: Aranesp® Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy
Study Start Date : January 2004
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Primary Outcome Measures :
  1. Hemoglobin maintenance

Secondary Outcome Measures :
  1. Quality of Life
  2. Changes in measures of work productivity and anemia treatment convenience

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 identifier (NCT number): NCT00117039

Sponsors and Collaborators
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Study Director: MD Amgen