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A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy


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

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy


Inclusion Criteria:



- Subjects with non-myeloid malignancy

- At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless
of schedule

- Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization

- Adequate serum folate and vitamin B12

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Of legal age at the time written informed consent is obtained

Exclusion Criteria:

- Known history of seizure disorder

- Known primary hematologic disorder causing anemia other than non-myeloid malignancies

- Unstable/uncontrolled cardiac condition

- Clinically significant inflammatory disease

- Other diagnoses not related to the cancer which can cause anemia

- Inadequate renal and liver function

- Iron deficiency

- Known positive test for HIV infection

- Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO

- Received more than 2 red blood cell (RBC) transfusions within 4 weeks of
randomization; or any RBC transfusion within 14 days before randomization; or any
planned RBC transfusion between randomization and study day 1

- Received any erythropoietic therapy within 4 weeks of study day 1 or any planned
erythropoietic therapy between randomization and study day 1

- Other investigational procedures

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

- Pregnant or breast feeding

- Not using adequate contraceptive precautions

- Previously randomized into this study

- Known hypersensitivity to any products to be administered

- Concerns for subject's compliance

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)

Outcome Time Frame:

from week 5 to EOTP

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20030232

NCT ID:

NCT00110955

Start Date:

February 2004

Completion Date:

April 2005

Related Keywords:

  • Anemia
  • Non-Myeloid Malignancies
  • Non-myeloid malignancy
  • Chemotherapy-induced anemia
  • Anemia
  • Neoplasms

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