Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00117039 |
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 |
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 |
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
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 |
anemia fatigue Aranesp® clinical trial |
Fatigue Hematinics Hematologic Diseases Darbepoetin alfa Anemia |
Neoplasms Hematinics Hematologic Diseases Therapeutic Uses |
Hematologic Agents Darbepoetin alfa Anemia Pharmacologic Actions |