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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 | Clinical Trials | Clareo Health

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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

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).

NCT01280240•Pharmacosmos A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women, aged more than 18 years.
•2. Weight above 50 kg.
•3. 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.
•4. Hb \< 12 g/dL.
•5. TfS \<20%.
•6. Serum Ferritin \<800 ng/ml.
•7. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
•8. Willingness to participate after informed consent.

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. 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 utilization 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 (ALAT) \> 3 times upper normal limit).
+9 more criteria

Locations (2)

Baltimore, MD, Maryland, United States

Gabrail Cancer Center

Canton, Ohio, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

September 1, 2012

Completion Date

November 1, 2012

Last Updated

June 4, 2013

Enrollment

ACTUAL participants

Conditions

Patients With Chemotherapy Induced Anemia (CIA)

Interventions

Monofer(R)

DRUG