P-Monofer-CIA-01

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  53820

• Contact name

  MD Tim Littlewood

• Sponsor organisation

  Pharmacosmos A/S

• Eudract number

  2009-016727-53

• ISRCTN Number

  N/A

• Research summary

  Iron deficiency anaemia is often associated with many chronic diseases such as renal diseases, cancer, infections (e.g. AIDS and malaria), chronic heart failure and inflammatory bowel disease. It is also common in elderly people who do not have any obvious symptoms of chronic disease. The mechanism behind anaemia in chronic disease is complex. In Chemotherapy Induced Anemia (CIA) patients with either absolute or functional iron deficiency anemia a safe alternative to Erythropoeisis Stimulating Agents (ESA??s) to correct anemia is warranted. The risks associated with the use of ESAs in cancer patients has recently been identified and include an increase in thrombotic events, decreased survival and shortened time to tumor progression.The rationale of the proposed study is to see whether or not Intravenous (IV) iron is able to fill the unmet medical need in cancer patients with CIA where ESAs either have been proscribed or are considered risky. The main objective of the study is to demonstrate that the investigational drug Iron Isomaltoside 1000 (Monofer) is as effective as oral iron sulphate in treatment of patients suffering from cancer (non-myeloid malignancies) and with chemotherapy induced anaemia (haemoglobin lower than 12 g/dl(7.4 mmol/L).Clinical safety data are present for Iron Isomaltoside 1000 (Monofer) but needs to be supplemented with further data.A total number of approximately 350 subjects will be randomized (like flipping a coin) in a ratio of 2:1 to either Iron Isomaltoside 1000 (Monofer©) or oral Iron Sulphate. The subjects randomized to Iron Isomaltoside 1000 (Monofer©) will be equally divided into groups A1 (administered as intravenous infusions) & A2 (administered as intravenous bolus injections).Subjects will at the trial hospital clinic be given intravenous infusions or repeated bolus injections of Iron Isomaltoside 1000 (Monofer©) or subjects will twice daily swallow a tablet of oral iron sulphate at home for 12 weeks.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/54

• Date of REC Opinion

  29 Oct 2010

• REC opinion

  Further Information Favourable Opinion