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

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

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
Drug: Aranesp®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

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

Keywords provided by Amgen:
clinical trial

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

ClinicalTrials.gov processed this record on April 17, 2014