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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

Tracking Information
First Submitted Date  ICMJE October 1, 2010
First Posted Date  ICMJE October 4, 2010
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2010)
Total serum iron pharmakokinetic parameters [ Time Frame: 24, 48 and 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01213979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-hematological Malignancies
Intervention  ICMJE
  • Drug: 500 mg iron isomaltoside 1000
    500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes
  • Drug: 1000 mg iron isomaltoside 1000
    1000 mg iron isomaltoside 1000 given as a infusion over 15 minutes
Study Arms  ICMJE
  • Active Comparator: 1000 mg iron isomaltoside 1000 as intravenous infusion
    Intervention: Drug: 1000 mg iron isomaltoside 1000
  • Active Comparator: 500 mg iron isomaltoside 1000 as bolus injection
    Intervention: Drug: 500 mg iron isomaltoside 1000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2010)
12
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT01213979
Other Study ID Numbers  ICMJE P-Monofer-PK-CIA-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmacosmos A/S
Study Sponsor  ICMJE Pharmacosmos A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pharmacosmos A/S
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP