Health Condition 1: null- Non-haematological malignancies associated with Chemotherapy Induced Anaemia (CIA)
Conditions
Interventions
Intervention1: Iron isomaltoside 1000 (Monofer®): administered as 500 mg IV bolus injections
Frequency :- Once Daily
Duration:- Once in study.
Intervention2: Iron isomaltoside 1000 (Monofer®): admi
Sponsors
Pharmacosmos AS
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men and women, aged more than 18 years. 2.Weight above 50 kg. 3.Subjects diagnosed with non-haematological malignancies (solid tumours only) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. 4.Hb 5.TfS 6.Serum Ferritin 7.An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 8.Willingness to participate after informed consent.
Exclusion criteria
Exclusion criteria: 1.Anaemia caused primarily by factors other than CIA. 2.IV or oral iron treatment within 4 weeks prior to Screening Visit. 3.Erythropoietin 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 utilisation of iron (e.g. haemochromatosis and haemosiderosis). 7.Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). 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 (ALT) > 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 (5 days) 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.Untreated Vitamin B12 or folate deficiency. 18.Any other medical condition that, in the opinion of 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. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess PK properties of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer®) in CIA subjects.Timepoint: Total serum iron pharmacokinetic parameters: AUC0-t, AUC, Cmax, tmax, Ke, and t1/2 at 30 minutes and 0 minutes predose, and at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess other laboratory measures of iron statusTimepoint: Concentration of haemoglobin (Hb), Ferritin, Total Iron Binding Capacity (TIBC) and TfS at pre-specified time points;To establish the effect of iron isomaltoside 1000 (Monofer®) on the reticulocyte countTimepoint: Change in reticulocyte count from study drug administration to 8, 24, 48 and 72 hours;To establish whether any excretion takes place in the urine after IV administration of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer®)Timepoint: Total Urine-iron pharmacokinetic variable sampled accumulatively during four time intervals following each dosing event: 0-8h, 8-24h, 24-48h, and 48-72h;To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®)Timepoint: Adverse events, laboratory safety variable, physical examination, vital signs, and Electrocardiogram (ECG) | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed