Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients

Inclusion Criteria

• Patients with a confirmed diagnosis of solid tumors
• Patients who receive cyclic palliative chemotherapy with a cycle duration of 1 -4 weeks (for at least 12 weeks) during the study
• Patients with chemotherapy associated anemia (hemoglobin 18
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2
• Serum ferritin greater or equal to 100 µg/l and/or saturated transferrin levels greater or equal to 20 %
• Adequate renal function (serum creatinine below or equal to 2.0 mg/dl)
• Adequate hepatic function (bilirubin 1500 pg/mL)
• Major surgery within 14 days prior to randomization
• Treatment with antiepileptics within the last 5 years
• Previously diagnosed HIV or acute hepatitis infection
• Uncontrolled hypertension, defined as a diastolic blood pressure measurement >110mm Hg during the screening period
• History of congestive heart failure (NYHA class III, IV)
• Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
• Evidence of acute infectious disease or serious active inflammatory disease within four weeks before screening (Visit -1) or during the screening/baseline period
• Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
• Pregnancy, breastfeeding women or women not using adequate birth control measures
• Patients who participate simultaneously in another clinical study or who have participated in a study in the month preceding the start of this study or previously randomized to this study (except studies with approved medications in an approved indication, with an approved dosing regimen including approved treatment combinations)
• Suspicion of any non-compliance