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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01280240
First received: January 19, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Patients With Chemotherapy Induced Anemia (CIA)
Drug: Monofer(R)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • 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. [ Time Frame: 0-7 days ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Monofer 500 mg Drug: Monofer(R)
Intravenous bolus injection given over app. 2 minutes only once
Other Name: iron isomaltoside 1000
Active Comparator: Monofer 250 mg Drug: Monofer(R)
Intravenous bolus injection given over app. 2 minutes only once
Other Name: iron isomaltoside 1000

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 <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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280240

Locations
United States, Maryland
Baltimore, MD, Maryland, United States, 21237
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States
Sponsors and Collaborators
Pharmacosmos A/S
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01280240     History of Changes
Other Study ID Numbers: P-Monofer-PK-CIA-06, PK-CIA-06
Study First Received: January 19, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacosmos A/S:
anemia
cancer
CIA

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014