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Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA) (PK-CIA-04)

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ClinicalTrials.gov Identifier: NCT01213979
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from non-hematological malignancies with Chemotherapy induced anaemia.

Condition or disease Intervention/treatment Phase
Non-hematological Malignancies Drug: 500 mg iron isomaltoside 1000 Drug: 1000 mg iron isomaltoside 1000 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)(PK-CIA-04)
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1000 mg iron isomaltoside 1000 as intravenous infusion Drug: 1000 mg iron isomaltoside 1000
1000 mg iron isomaltoside 1000 given as a infusion over 15 minutes
Active Comparator: 500 mg iron isomaltoside 1000 as bolus injection Drug: 500 mg iron isomaltoside 1000
500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes



Primary Outcome Measures :
  1. Total serum iron pharmakokinetic parameters [ Time Frame: 24, 48 and 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 <50%.
  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. 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 utilization 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 (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. 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.

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01213979     History of Changes
Other Study ID Numbers: P-Monofer-PK-CIA-04
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Neoplasms
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics