Status:
COMPLETED
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 compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00110955
Start Date
February 1 2004
End Date
April 1 2005
Last Update
January 15 2010
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