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A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia
This study has been completed.
First Received: June 30, 2005   Last Updated: October 14, 2008   History of Changes
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00117039
  Purpose

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 Intervention Phase
Anemia
Neoplasms
Drug: Aranesp®
Phase IV

MedlinePlus related topics: Anemia Cancer
Drug Information available for: Darbepoetin alfa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Hemoglobin maintenance

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

Estimated Enrollment: 1500
Study Start Date: January 2004
Estimated Study Completion Date: April 2005
  Eligibility

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117039

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

Additional Information:
Publications:
Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20030206
Study First Received: June 30, 2005
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00117039     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
anemia
fatigue
Aranesp®
clinical trial

Study placed in the following topic categories:
Fatigue
Hematinics
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:
Neoplasms
Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents
Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009