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


Phase 1
18 Years
N/A
Not Enrolling
Both
Patients With Chemotherapy Induced Anemia (CIA)

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Trial Information

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


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).

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. Pregnant or breast feeding women.

15. 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.

16. Planned elective surgery during the study.

17. Participation in any other clinical study (except chemotherapy protocol) within 3
months prior to screening.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Time Frame:

0-7 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P-Monofer-PK-CIA-06

NCT ID:

NCT01280240

Start Date:

March 2012

Completion Date:

November 2012

Related Keywords:

  • Patients With Chemotherapy Induced Anemia (CIA)
  • anemia
  • cancer
  • CIA
  • Anemia

Name

Location

Baltimore, Maryland  21287
Gabrail Cancer CenterCanton, Ohio  44718