A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl)
undergoing palliative care chemotherapy will enter this 12 week single arm open label study.
Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every
2 weeks. Up or down titration will be performed according to the currently approved
prescription guidance for a total of 12 weeks of treatment. Study end points will be
assessed every 4 weeks until final 12 week visit.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
Baseline to 12 weeks
Roberto Diez, MD
Bio Sidus SA
Argentina: Ministry of Health