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A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Anemia of Cancer, Cancer, Carcinoma, Neoplasms, Non-Myeloid Malignancies

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Trial Information

A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer


Inclusion Criteria:



- nonmyeloid malignancies (including lymphocytic leukemias)

- anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer
and/or previous chemotherapy or radiotherapy

- Eastern Cooperative Oncology Group performance status of 0 to 2

- adequate liver and renal functions

- 18 years or older

Exclusion Criteria:

- history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more
than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening

- acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome

- known hematologic disorders that could cause anemia

- inflammatory or cardiac disorders

- previous positive antibody response to any erythropoietic agent

- history of pure red cell aplasia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

to estimate the difference in number of hospital days, number of subject hospitalized, and number of hospitalizations over 12 weeks between subjects by randomized treatment group

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20000219

NCT ID:

NCT00989092

Start Date:

May 2002

Completion Date:

June 2004

Related Keywords:

  • Anemia
  • Anemia of Cancer
  • Cancer
  • Carcinoma
  • Neoplasms
  • Non-Myeloid Malignancies
  • anemia of cancer
  • darbepoetin alfa
  • Aranesp
  • Anemia
  • Neoplasms
  • Carcinoma

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