Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00306267
Eligibility Criteria:
Inclusion Criteria:
* Patients must have "Active non-myeloid cancer malignancy" or incurable cancer with a life expectancy of 6 months or more
* Patients may also have had cancer treatment within the past 2 years but no chemotherapy or radiation therapy within the past 8 weeks prior to enrollment
* must be \>= 18 years of age and must not be receiving or planning to receive cytotoxic chemotherapy or external beam radiotherapy during the study period
* must have a baseline Hb \<= 11 g/dL.
* Patients with reproductive potential must be practicing an effective method of birth control and women cannot be pregnant or breast-feeding during the study period
* Patients must be able to comply with all requirements of the study (i.e. study visit schedules) and patients (or their legally authorized representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
* Patients receiving or planning to receive chemotherapy or radiation therapy within 8 weeks of study entry
* Anemia due to factors other than cancer
* Previous treatment with epoetin alfa or any form of erythropoietin during the previous 1 month or received an experimental drug or device within past 30 days
* Known hypersensitivity to mammalian-cell derived products or to human albumin
* Untreated known central nervous system (CNS) metastases
* Uncontrolled or clinically severe disease of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
* History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events, cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS) \[unstable angina, myocardial infarction (MI)\], or other arterial thrombosis
* Currently receiving therapeutic or prophylactic anticoagulants
* Transfusion of packed red blood cells within 28 days prior to the first dose of study drug, or planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00306267
Study Brief:
Protocol Section:
NCT00306267