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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)

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ClinicalTrials.gov Identifier: NCT01280240
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE January 19, 2011
First Posted Date  ICMJE January 20, 2011
Last Update Posted Date June 4, 2013
Study Start Date  ICMJE March 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
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.
Change History Complete list of historical versions of study NCT01280240 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 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
Official Title  ICMJE 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).
Brief Summary 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.
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: Basic Science
Condition  ICMJE Patients With Chemotherapy Induced Anemia (CIA)
Intervention  ICMJE Drug: Monofer(R)
Intravenous bolus injection given over app. 2 minutes only once
Other Name: iron isomaltoside 1000
Study Arms  ICMJE
  • Active Comparator: Monofer 500 mg
    Intervention: Drug: Monofer(R)
  • Active Comparator: Monofer 250 mg
    Intervention: Drug: Monofer(R)
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: November 13, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2011)
12
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date September 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 <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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01280240
Other Study ID Numbers  ICMJE P-Monofer-PK-CIA-06
PK-CIA-06
Has Data Monitoring Committee Yes
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