Phase 4
Completed N=504
A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia
Anemia · Neoplasms
Source: ClinicalTrials.gov NCT01394991 ↗
Enrolled (actual)
504
Serious AEs
23.2%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16 — 5; 10 particpants — p=0.248
Summary
The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16 |
5; 10 | 0.248 |
| SECONDARY Number of Positively Adjudicated Thrombovascular Events |
5; 13 | 0.08 |
| SECONDARY Time to First Positively Adjudicated Thrombovascular Event |
5; 13 | 0.073 |
| SECONDARY Number of Suspected Thrombovascular Events |
9; 20 | 0.059 |
| SECONDARY Time to First Suspected Thrombovascular Event |
9; 20 | 0.054 |
| SECONDARY Mortality |
25; 26 | 0.88 |
| SECONDARY Number of Hemoglobin Responders |
179; 187 | 0.514 |
| SECONDARY Red Blood Cell Transfusions |
38; 42 | 0.920 |
Eligibility Criteria
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 therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin [LMWH], except for prevention of central venous catheter thrombosis at doses specified in the protocol, direct thrombin inhibitors, or anti-platelet drugs [e.g., clopidogrel or ticlopidine]), except for prophylaxis in patients with known cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT01394991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.