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)

NCT01145638 | Completed Phase 3 Results

• 2 other identifiers: P-Monofer-CIA-01EudraCT no. 2009-016727-53
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-myeloid Malignancies; Chemotherapy Induced Anaemia

Keywords

cancer; chemotherapy induced anaemia; iron; Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA); CIA

Outcome Measures

Primary Outcomes (1)

• Change in Hb Concentration

  Baseline week 4

Secondary Outcomes (1)

• Change in Hemoglobin From Baseline to Week 24

  24 weeks

Study Arms (2)

iron isomaltoside 1000

EXPERIMENTAL

Iron isomaltoside intravenously as bolus or infusion

Drug: iron isomaltoside 1000

iron sulphate

ACTIVE COMPARATOR

oral iron sulphate twice a day

Drug: iron sulphate

Interventions

iron isomaltoside 1000 DRUG

intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

Also known as: Monofer

iron isomaltoside 1000

iron sulphate DRUG

oral, 200 mg per day (100 mg bid),12 weeks

Also known as: Ferroduretter

iron sulphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Apollo Hospitals

New Delhi, India

Location

Related Publications (1)

• 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.

  PMID: 26927900 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

iron isomaltoside 1000; Iron-Dextran Complex

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Vice President Research & Development Department
• Organization: Pharmacosmos A/S

llt@pharmacosmos.com

+45 59485959

Study Officials

• Lars Lykke Thomsen, MD

  Pharmacosmos A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 3, 2015
• Results First Posted: December 3, 2015

Record last verified: 2015-04

Locations

IN (1)