Health Condition 1: null- Iron Deficiency Anemia in CIA patients Phase III, prospective, open-label, randomized comparative study
Conditions
Interventions
Intervention1: Iron Isomaltoside 1000: Administered as intravenous infusion (A1) of maximum 1000 mg iron until full replacement dose is achieved
Administered as intravenous Bolus injection (A2) of 50
Sponsors
Pharmacosmos AS
Max Neeman international
Eligibility
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: 1. Anaemia caused primarily by other factors than CIA. 2. IV or oral iron treatment within 4 weeks prior to screening visit. 3. Erythrypoietin treatment within 4 weeks prior to screening visit. 4. Blood transfusion within 4 weeks prior to screening visit. 5. Imminent expectation of blood transfusion on part of treating physician. 6. Iron overload or disturbances in enrolment of iron (e.g. haemochromatosis and haemosiderosis). 7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate). 8. Known hypersensitivity to any excipients in the investigational drug products. 9. Subjects with a history of multiple allergies. 10. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) 3 times upper normal limit). 11. History of Immunocompromise and/or history of Hepatitis B and/or C. 12. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)). 13. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 14. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). 15. Planned elective surgery during the study. 16. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. 17. Known intolerance to oral iron treatment. 18. Untreated B12 or folate deficiency. 19. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that intravenous iron oligosaccharide 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.Timepoint: wk 1, 2, 4, 8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®) for the correction of CIA in subjects with non-myeloid malignancies2.Compare drug related AE?s between Monofer® & oral iron sulfate3.Compare iron related hematological parameters4.Assess subjects who discontinue study due to lack of response or intolerance5.Assess Quality of Life6.Assess RLS symptoms & change during the study 7.Detect the impact of the study drug upon the ability to complete the planned chemotherapyTimepoint: 1, 2, 4,8,12 and 24 weeks | — |
Countries
Denmark, India, Sweden, United Kingdom
Contacts
Public ContactDrShariq Anwar
Max Neeman International
Outcome results
None listed