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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117039
• Other study ID #: 20030206
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2005
• Last updated: October 14, 2008
• Start date: January 2004
• Est. completion date: April 2005

Study information

• Verified date: August 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms

Intervention

Drug:
• Aranesp®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

Boccia R, Lillie T, Tomita D, Balducci L. The effectiveness of darbepoetin alfa administered every 3 weeks on hematologic outcomes and quality of life in older patients with chemotherapy-induced anemia. Oncologist. 2007 May;12(5):584-93. — View Citation

Boccia R, Malik IA, Raja V, Kahanic S, Liu R, Lillie T, Tomita D, Clowney B, Silberstein P. Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia. Oncologist. 2006 Apr;11(4):409-17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin maintenance
Secondary	Quality of Life
Secondary	Changes in measures of work productivity and anemia treatment convenience

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling