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A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Non-Myeloid Malignancies

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Trial Information

A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy


Inclusion Criteria:



- Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8
additional weeks or more

- Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to
11.0 g/dL) related to cancer and chemotherapy

- Karnofsky performance status of greater than or equal to 50%

- Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and
serum creatinine concentration of less than or equal to 2.0 mg/dL

Exclusion Criteria:

- Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or
myelodysplastic syndromes

- Hematologic disorder previously associated with anemia

- Active bleeding

- Iron deficiency

- Received erythropoietic therapy within 14 days prior to randomization

- Unstable cardiac disease

- Known positive human immunodeficiency virus antibody or hepatitis B surface antigen

- Known positive antibody response to any erythropoietic agent

- Currently enrolled in, or has not yet completed at least 30 days since ending other
investigational device or drug trial or is receiving investigational agent(s) not
approved for any indication

- Pregnant or breast feeding

- Red blood cell (RBC) transfusion within 4 weeks of screening

- Known hypersensitivity to any recombinant mammalian-derived product

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to hematopoietic response during the comparative treatment period

Outcome Time Frame:

during the comparative treatment period

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20020139

NCT ID:

NCT00111137

Start Date:

February 2003

Completion Date:

April 2004

Related Keywords:

  • Cancer
  • Non-Myeloid Malignancies
  • darbepoetin alfa
  • anemia
  • Amgen
  • Chemotherapy
  • Neoplasms

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