A phase III, randomized, open-label study of intravenous iron isomaltoside 1000 (Monofer®) as mono therapy (without erythropoeisis stimulating agents) in comparison with oral iron sulfate in subjects with non-myeloid malignancies associated with Chemotherapy induced anaemia (CIA). - P-Monofer-CIA-01

INTERVENTION: Trade Name: Monofer 100 mg/ml Product Name: Monofer 100 mg/ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: Iron isomaltoside 1000 CAS Number: 9004‐66‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Ferro Duretter,prolonged release tablet Product Name: Ferro Duretter, Prolonged release tablet Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: Iron Sulphate CONDITION: Non‐myeloid malignancies associated with Chemotherapy induced anaemia (CIA) ; MedDRA version: 12 Level: LLT Classification code 10064014 Term: Cancer anemia PRIMARY OUTCOME: Main Objective: To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is non‐inferior to oral iron sulphate in the ability to increase haemoglobin (Hb) in patients with chemotherapy induced anemia and either absolute or functional iron deficiency. Primary end point(s): The primary endpoint of the study is change in Hb concentration from baseline to week 12 Secondary Objective: • To obtain safety data with the use of iron isomaltoside 1000 (Monofer®) for the ; correction of CIA in subjects with non‐myeloid malignancies. ; • To compare study drug related adverse events after iron isomaltoside 1000; (Monofer®) to study drug related adverse events in subjects treated with oral ; iron sulfate.; • To assess iron related hematological and biochemical parameters ; • To assess subjects who discontinue study due to lack of response or intolerance.; • To assess Quality of Life. ; • Assessment of RLS symptoms and change in these symptoms during the study.; • To detect the impact of the study drug upon the ability to complete the planned; chemotherapy; • To detect the impact of the study drug upon response to the chemotherapy; INCLUSION CRITERIA: 1. Men and women, aged more than 18 years. 2. Subjects diagnosed with cancer (non‐myeloid malignancies) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. 3. Hb < 12 g/dL. (7.4 mmol/L) 4. TfS <50%. 5. Serum Ferritin <800 ng/ml. 6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Willingness to participate after informed consent (including HIPAA, if applicable). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range