A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia - Full Text View

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 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:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

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:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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:

anemia
fatigue
Aranesp®
clinical trial

Additional relevant MeSH terms:

Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa

Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013