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


Inclusion Criteria:



- Non-myeloid malignancy

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

- Eastern Cooperative Oncology Group performance status of 0-2

- Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization

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

Exclusion Criteria:

- Known history of seizure disorder

- Known primary hematologic disorder, which could cause anemia, other than a
non-myeloid malignancy

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

- Clinically significant inflammatory disease

- Inadequate renal and/or liver function

- Known positive HIV test

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

- Received more than 2 red blood cell (RBC) transfusions within 4 weeks before
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 before randomization or any
planned erythropoietic therapy between randomization and study day 1

- Other investigational procedures

- Subject is currently enrolled in or 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

- Not using adequate contraceptive precautions

- Known sensitivity to any of the products to be administered during dosing

- Previously randomized in this study

- Concerns for subject's compliance with protocol procedures

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 at least one 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:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

20030231

NCT ID:

NCT00118638

Start Date:

March 2004

Completion Date:

January 2005

Related Keywords:

  • Anemia
  • Non-Myeloid Malignancies
  • Non-myeloid malignancy
  • Darbepoetin alfa
  • Clinical Trial
  • Anemia
  • Neoplasms

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