Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

Study Overview
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Brief Summary
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The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.

Official Title
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Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA).

Conditions
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Patients With Chemotherapy Induced Anemia (CIA)

Intervention / Treatment
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* Drug: Monofer(R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, aged more than 18 years. Weight above 50 kg. Subjects diagnosed with non-hematological malignancies (solid tumors only) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. Hb < 12 g/dL. TfS <20%. Serum Ferritin <800 ng/ml. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Willingness to participate after informed consent. Exclusion Criteria: Anaemia caused primarily by other factors than CIA. IV or oral iron treatment within 4 weeks prior to screening visit. Erythropoietin treatment within 4 weeks prior to screening visit. Blood transfusion within 4 weeks prior to screening visit. Imminent expectation of blood transfusion on part of treating physician. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). Known hypersensitivity to any excipients in the investigational drug products. Subjects with a history of multiple allergies. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit). History of Immunocompromise and/or history of Hepatitis B and/or C. 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)). Rheumatoid arthritis with symptoms or signs of active joint inflammation. Pregnant or breast feeding women. Women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period. Planned elective surgery during the study. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. Untreated B12 or folate deficiency. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monofer 500 mg<br> | Drug: Monofer(R)<br>* Intravenous bolus injection given over app. 2 minutes only once<br>* Other names: iron isomaltoside 1000;|
| Active Comparator: Monofer 250 mg<br> | Drug: Monofer(R)<br>* Intravenous bolus injection given over app. 2 minutes only once<br>* Other names: iron isomaltoside 1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum iron pharmacokinetic parameters: AUC0-t, AUC Cmax, Tmax, Ke, and T1/2 estimated from plasma/serum concentration profile from exposure to 7 days post-exposure. |  | 0-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, cancer, CIA