Patients With Chemotherapy Induced Anemia (CIA)Phase 1PK-CIA-06NCT01280240
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
A Phase 1 study testing Monofer(R) in people with Patients With Chemotherapy Induced Anemia (CIA), run by Pharmacosmos A/S at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Chemotherapy Induced Anemia (CIA)
- What is being tested?
- Monofer(R)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Nov 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 <20%.
- 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.
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Baltimore, MD, Maryland, 21237
Gabrail Cancer Center
Canton, Ohio
About this study
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).
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.
- Being tested
- Monofer(R)
- Keywords
- anemia, cancer, CIA
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofer(R)Drug
Also called iron isomaltoside 1000
Intravenous bolus injection given over app. 2 minutes only once
| Study group | Role | What they receive |
|---|---|---|
| Monofer 500 mg | Active comparator | Not described Receives: Drug: Monofer(R) |
| Monofer 250 mg | Active comparator | Not described Receives: Drug: Monofer(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Chemotherapy Induced Anemia (CIA)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT01280240
- Sponsor's protocol ID
- P-Monofer-PK-CIA-06
- Other IDs
- PK-CIA-06
- Acronym
- PK-CIA-06
- Status last verified
- Jun 2013
- First submitted
- 19 Jan 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 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 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA).
- ClinicalTrials.gov ID
- NCT01280240
- Acronym / sponsor ID
- PK-CIA-06 / P-Monofer-PK-CIA-06
- Keywords
- anemia, cancer, CIA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Jan 2011 (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 Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monofer 500 mg | Active comparator | Drug: Monofer(R) |
| Monofer 250 mg | Active comparator | Drug: Monofer(R) |
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 <20%.
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.
- 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.
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 |
|---|---|---|
| Monofer(R)Also: iron isomaltoside 1000Intravenous bolus injection given over app. 2 minutes only once | Drug | Monofer 250 mg, Monofer 500 mg |
Primary outcome
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
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 4 Jun 2013.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monofer(R) in people with Patients With Chemotherapy Induced Anemia (CIA), run by Pharmacosmos A/S at 2 sites in United States.
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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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). 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 4 Jun 2013.