Non-hematological MalignanciesPhase 1PK-CIA-04NCT01213979
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)
A Phase 1 study testing 500 mg iron isomaltoside 1000 and 1000 mg iron isomaltoside 1000 in people with Non-hematological Malignancies, run by Pharmacosmos A/S.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hematological Malignancies
- What is being tested?
- 500 mg iron isomaltoside 1000 and 1000 mg iron isomaltoside 1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <50%.
- Serum Ferritin <800 ng/ml.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Willingness to participate after informed consent.
Who cannot join
- Anaemia caused primarily by other factors than CIA.
- IV or oral iron treatment within 4 weeks prior to screening visit.
- Erythrypoietin 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).
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- Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
- 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.
- 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).
- Planned elective surgery during the study.
- Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
- Known intolerance to oral iron treatment.
- 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.
About this study
Official title: 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)
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.
- Conditions
- Non-hematological Malignancies
- Being tested
- 500 mg iron isomaltoside 1000, 1000 mg iron isomaltoside 1000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mg iron isomaltoside 1000Drug
500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes
1000 mg iron isomaltoside 1000Drug
1000 mg iron isomaltoside 1000 given as a infusion over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1000 mg iron isomaltoside 1000 as intravenous infusion | Active comparator | Not described Receives: Drug: 1000 mg iron isomaltoside 1000 |
| 500 mg iron isomaltoside 1000 as bolus injection | Active comparator | Not described Receives: Drug: 500 mg iron isomaltoside 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum iron pharmakokinetic parameters
Measured: 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213979
- Sponsor's protocol ID
- P-Monofer-PK-CIA-04
- Acronym
- PK-CIA-04
- Status last verified
- Jun 2013
- First submitted
- 1 Oct 2010
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01213979
- Acronym / sponsor ID
- PK-CIA-04 / P-Monofer-PK-CIA-04
- Conditions
- Non-hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1000 mg iron isomaltoside 1000 as intravenous infusion | Active comparator | Drug: 1000 mg iron isomaltoside 1000 |
| 500 mg iron isomaltoside 1000 as bolus injection | Active comparator | Drug: 500 mg iron isomaltoside 1000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 <50%.
Key exclusion criteria (19 listed)
- Anaemia caused primarily by other factors than CIA.
- IV or oral iron treatment within 4 weeks prior to screening visit.
- Erythrypoietin 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500 mg iron isomaltoside 1000500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes | Drug | 500 mg iron isomaltoside 1000 as bolus injection |
| 1000 mg iron isomaltoside 10001000 mg iron isomaltoside 1000 given as a infusion over 15 minutes | Drug | 1000 mg iron isomaltoside 1000 as intravenous infusion |
Primary outcome
Total serum iron pharmakokinetic parameters
Time frame: 24, 48 and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 500 mg iron isomaltoside 1000 and 1000 mg iron isomaltoside 1000 in people with Non-hematological Malignancies, run by Pharmacosmos A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total serum iron pharmakokinetic parameters (time frame: 24, 48 and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.