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 (PK-CIA-06)

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).

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.

Study Overview

• Status: Completed
• Conditions: Patients With Chemotherapy Induced Anemia (CIA)
• Intervention / Treatment: Drug: Monofer(R)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, MD, Maryland, United States, 21237
  • Ohio
    • Canton, Ohio, United States
      • Gabrail Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: cancer; anemia; CIA
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: P-Monofer-PK-CIA-06; PK-CIA-06