Status:
COMPLETED
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
Lead Sponsor:
Amgen
Conditions:
Anemia
Non-Myeloid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT00118638
Start Date
March 1 2004
End Date
January 1 2005
Last Update
April 29 2013
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