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A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Neoplasms, Anemia

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Trial Information

A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy


Inclusion Criteria:



- Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to
receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time
of first dose of study drug

- Screening hemoglobin concentration less than or equal to 11.0 g/dL

- ECOG performance status of 0 to 2 (inclusive)

Exclusion Criteria:

- History of seizure disorder

- Primary hematologic disorder that could cause anemia

- Unstable or uncontrolled disease/condition related to or affecting cardiac function

- Clinical evidence of chronic infection/inflammatory disease

- Positive test for HIV infection

- Previously confirmed neutralizing antibodies to rHuEPO

- Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more
than 2 RBC transfusion occurences

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 first hemoglobin response during the treatment period

Outcome Time Frame:

during the treatment period

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement

Study ID:

20010101

NCT ID:

NCT00038064

Start Date:

January 2002

Completion Date:

April 2004

Related Keywords:

  • Neoplasms
  • Anemia
  • anemia of cancer/chemotherapy
  • non-myeloid malignancies
  • Drug Therapy
  • Anemia
  • Neoplasms

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