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SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Anemia, Neoplasms

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Trial Information

SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hemoglobin maintenance

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20030206

NCT ID:

NCT00117039

Start Date:

January 2004

Completion Date:

April 2005

Related Keywords:

  • Anemia
  • Neoplasms
  • anemia
  • fatigue
  • Aranesp®
  • clinical trial
  • Anemia
  • Neoplasms

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