- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280240
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)
June 3, 2013 updated by: Pharmacosmos A/S
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, MD, Maryland, United States, 21237
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Ohio
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Canton, Ohio, United States
- Gabrail Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Men and women, aged more than 18 years.
- Weight above 50 kg.
- 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.
- Hb < 12 g/dL.
- TfS <20%.
- Serum Ferritin <800 ng/ml.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Willingness to participate after informed consent.
Exclusion Criteria:
- Anaemia caused primarily by other factors than CIA.
- IV or oral iron treatment within 4 weeks prior to screening visit.
- Erythropoietin treatment within 4 weeks prior to screening visit.
- Blood transfusion within 4 weeks prior to screening visit.
- Imminent expectation of blood transfusion on part of treating physician.
- Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
- Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes).
- Known hypersensitivity to any excipients in the investigational drug products.
- Subjects with a history of multiple allergies.
- Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
- History of Immunocompromise and/or history of Hepatitis B and/or C.
- 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)).
- Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- Pregnant or breast feeding women.
- 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.
- Planned elective surgery during the study.
- Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
- Untreated B12 or folate deficiency.
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Monofer 500 mg
|
Intravenous bolus injection given over app. 2 minutes only once
Other Names:
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Active Comparator: Monofer 250 mg
|
Intravenous bolus injection given over app. 2 minutes only once
Other Names:
|
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.
Time Frame: 0-7 days
|
0-7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-Monofer-PK-CIA-06
- PK-CIA-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With Chemotherapy Induced Anemia (CIA)
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-
Universitaire Ziekenhuizen KU LeuvenCompletedExploration of How Patients Deal With Side Effects From ChemotherapyBelgium
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FibroGenCompleted
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Clinical Trials on Monofer(R)
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Pharmacosmos A/SCompletedAnemia, Iron-Deficiency | Chronic Kidney DiseaseDenmark
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Pharmacosmos A/SCompleted
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Pharmacosmos A/SMax NeemanCompleted
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Pharmacosmos A/SClinSmartCompleted
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Yonsei UniversityNot yet recruitingKidney Failure, ChronicKorea, Republic of