Non-myeloid MalignanciesPhase 3NCT01145638

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

A Phase 3 study testing iron isomaltoside 1000 and iron sulphate in people with Non-myeloid Malignancies and Chemotherapy Induced Anaemia, run by Pharmacosmos A/S at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-myeloid Malignancies, Chemotherapy Induced Anaemia
What is being tested?: iron isomaltoside 1000 and iron sulphate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 1 siteIndia
Study dates: Oct 2010to May 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Subjects diagnosed with cancer (non-myeloid malignancies) 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 (7.4 mmol/L).
TfS <50%.
Serum Ferritin <800 ng/ml.
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
Willingness to participate after informed consent (including HIPAA, if applicable).

Who cannot join

Anemia 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 or to iron sulfate).
Known hypersensitivity to any excipients in the investigational drug products.
Subjects with a history of multiple allergies.
Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
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 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.

Trial locations and contacts

1 site in 1 country.

India1 site

Apollo Hospitals
New Delhi

Other trials in India

About this study

Official title: A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

Conditions: Non-myeloid Malignancies, Chemotherapy Induced Anaemia
Being tested: iron isomaltoside 1000, iron sulphate
Keywords: cancer, chemotherapy induced anaemia, iron, Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA), CIA
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iron isomaltoside 1000Drug
Also called Monofer
intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
iron sulphateDrug
Also called Ferroduretter
oral, 200 mg per day (100 mg bid),12 weeks

Study groups in NCT01145638
Study group	Role	What they receive
iron isomaltoside 1000	Experimental	Iron isomaltoside intravenously as bolus or infusion Receives: Drug: iron isomaltoside 1000
iron sulphate	Active comparator	oral iron sulphate twice a day Receives: Drug: iron sulphate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hb Concentration
Measured: Baseline week 4

Secondary outcomes (1)

Change in Hemoglobin From Baseline to Week 24
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010May 2014

First posted16 Jun 2010 (estimated)
Study startOct 2010
Primary completionApr 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-myeloid 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145638
Sponsor's protocol ID: P-Monofer-CIA-01
Other IDs: EudraCT no. 2009-016727-53
Status last verified: Apr 2015
First submitted: 15 Jun 2010
Last updated: 3 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Birgegard G, Henry D, Glaspy J, Chopra R, Thomsen LL, Auerbach M. A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial. Pharmacotherapy. 2016 Apr;36(4):402-14. doi: 10.1002/phar.1729. Epub 2016 Apr 1.
PubMed 26927900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)
ClinicalTrials.gov ID: NCT01145638
Acronym / sponsor ID: P-Monofer-CIA-01
Conditions: Non-myeloid Malignancies, Chemotherapy Induced Anaemia
Keywords: cancer, chemotherapy induced anaemia, iron, Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA), CIA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Pharmacosmos A/SIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2014 (actual)
Study completion: May 2014 (actual)
First posted: 16 Jun 2010 (estimated)
Results: Posted 3 Dec 2015

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 compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and 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
iron isomaltoside 1000	Experimental	Drug: iron isomaltoside 1000Iron isomaltoside intravenously as bolus or infusion
iron sulphate	Active comparator	Drug: iron sulphateoral iron sulphate twice a day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men and women, aged more than 18 years.
Subjects diagnosed with cancer (non-myeloid malignancies) 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 (7.4 mmol/L).
TfS <50%.
Serum Ferritin <800 ng/ml.

Key exclusion criteria (18 listed)

Anemia 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
iron isomaltoside 1000Also: Monoferintravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose	Drug	iron isomaltoside 1000
iron sulphateAlso: Ferroduretteroral, 200 mg per day (100 mg bid),12 weeks	Drug	iron sulphate

Primary outcome

Change in Hb Concentration
Time frame: Baseline week 4

1 secondary outcome

Change in Hemoglobin From Baseline to Week 24
Time frame: 24 weeks

Results and safety

Results posted to the registry on 3 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iron Isomaltoside 1000	231	141
Iron Sulphate	119	62

Primary outcome: Change in Hb Concentration

Time frame: Baseline week 4. Mean (Full Range). Unit: g/dL

Measure	Iron Isomaltoside 1000 n = 192	Iron Sulphate n = 99
Value	0.48 (-4 to 4)	0.44 (-2 to 4)

Population analysed: The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iron Isomaltoside 1000	32 of 229 (14%)	173 of 229 (75.5%)	Not reported
Iron Sulphate	18 of 112 (16.1%)	107 of 112 (95.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26927900Birgegard G, Henry D, Glaspy J, Chopra R, Thomsen LL, Auerbach M. A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial. Pharmacotherapy. 2016 Apr;36(4):402-14. doi: 10.1002/phar.1729. Epub 2016 Apr 1.

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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.

Lars Lykke Thomsen, MD study chair

Pharmacosmos A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iron isomaltoside 1000 and iron sulphate in people with Non-myeloid Malignancies and Chemotherapy Induced Anaemia, run by Pharmacosmos A/S at 1 site in India.

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 7 inclusion and 18 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Hb Concentration (time frame: Baseline week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145638, which also lists 1 linked publication.

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 3 Dec 2015.