A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia (NCT01394991) | Clinical Trial Compass
CompletedPhase 4
A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia
504 participantsStarted 2006-01
Plain-language summary
The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Any nonmyeloid tumor confirmed by cytology and/or histology
* Day 1 baseline hemoglobin (Hb) level \<=11 g/dL
* Expected to receive at least 12 weeks of chemotherapy after enrollment into the study
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
Exclusion Criteria:
* History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer
* History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment
* History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry
* Onset of seizures within 3 months before randomization or poorly controlled seizures
* Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy
* Specifically excluded concomitant medications or therapies including prophylactic anticoagulation the…
What they're measuring
1
Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16
Timeframe: from randomization through Week 16
Trial details
NCT IDNCT01394991
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.