Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer

Inclusion Criteria:

• Written informed consent
• Female or male aged >18 years
• Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven malignancy, either hematological or solid tumor, of any grade or stage: Hemoglobin (Hb) 7.0 g/dL to 10 g/dL, Transferrin saturation (TSAT) <50%, Serum iron <50 µg/dL (SI: <9.0 µmol/L), AND Ferritin >30 ng/mL (SI: >30 µg/L)
• Previous treatment with systemic anti-cancer therapy / regimen
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
• Estimated life expectancy ≥12 weeks
• Men must agree to follow effective contraception methods during treatment and for 3 months after completion of treatment. Women of childbearing potential must agree to use two forms of effective contraception during treatment and for 3 months after completion of treatment.

Exclusion Criteria:

• Inability to personally provide written informed consent or to understand and collaborate throughout the study
• History of pure red cell aplasia, thalassemia major or sickle cell disease History of anemia unrelated to cancer <10 g/dL within 6 months prior to screening
• Uncorrected iron deficiency
• Regular need for blood transfusions at intervals <6 weeks
• Acute or myeloid leukemia
• Known or suspected chronic bleeding
• Tumor with gastro-intestinal involvement without negative test for fecal occult blood
• Suspected or known history of hemochromatosis
• Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
• Impaired liver function with bilirubin ≥2.0 mg/dL (26 μmol/L), AST or ALT ≥2 times upper limit
• History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic steatosis, hepatic cirrhosis, or organ transplantation
• Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min (Cockcroft-Gault)
• Known central nervous system malignancy or metastasis
• Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure [BP] >150 mmHg or diastolic BP >100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
• Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
• Previous participation in this study or treatment with an investigational agent <21 days prior to treatment start
• Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to treatment start
• Treatment with erythropoiesis-stimulating agents (ESAs) or red blood cell (RBC) transfusions <21 days prior to treatment start
• Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (e.g. lenalidomide, interferon)