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A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Phase 3
18 Years
Not Enrolling
Anemia, Cancer

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Trial Information

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

Inclusion Criteria:

- subjects with non-myeloid malignancies

- anemia due to cancer

- ECOG status 0 to 2

- greater than or equal to 4-month expectancy

- greater than or equal to 18 years and of legal age for informed consent

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

- adequate serum folate and vitamin B12

- adequate renal and liver function

- written informed consent

Exclusion Criteria:

- subjects currently receiving or planned to receive cytotoxic chemotherapy or
myelosuppressive radiotherapy during the study or within 4 weeks before randomization

- in complete remission, as determined by the investigator

- subjects who have other diagnoses not related to the cancer which cause anemia (eg.
gastrointestinal bleeding, renal disease, etc)

- documented history of pure red cell aplasia

- Known history of seizure disorder

- cardiac condition: uncontrolled angina, congestive heart failure, known ejection
fraction less than 40%, or uncontrolled cardiac arrhythmia

- uncontrolled hypertension

- clinically significant systemic infection or chronic inflammatory disease present at
the time of randomization

- iron deficiency

- known positive test for HIV infection

- previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or
darbepoetin alfa

- received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization

- less than 30 days since receipt of any investigational drug or device that is not
approved by the applicable regulatory authority

- pregnant or breast feeding

- subject of reproductive potential who is not using adequate contraceptive precautions

- known hypersensitivity to mammalian-derived product or any other ingredients in the
investigational product

- previously randomized into this study

- concerns for subject's compliance with the protocol procedures

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Occurrences of red blood cell transfusion

Outcome Time Frame:

from study day 29 (week 5) to week 17

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Therapeutic Goods Administration

Study ID:




Start Date:

April 2004

Completion Date:

December 2006

Related Keywords:

  • Anemia
  • Cancer
  • Cancer-related anemia
  • Anemia