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)

Non-myeloid Malignancies Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145638
• Other study ID #: P-Monofer-CIA-01
• Secondary ID: EudraCT no. 2009
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2010
• Last updated: November 2, 2015
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia: The Drugs Controler IndiaSweden: Medical Products AgencyGermany: BundesInstitut Für Arsneimittel und MedizinprodukteSpain: Agencia Española de Medicamentos y Productos SanitariosRussia: The Ministry of Health of the Russian FederationPoland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUSA: The Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women, aged more than 18 years.

2. 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.

3. Hb < 12 g/dL (7.4 mmol/L).

4. TfS <50%.

5. Serum Ferritin <800 ng/ml.

6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to

7. Willingness to participate after informed consent (including HIPAA, if applicable).

Exclusion Criteria:

1. Anemia caused primarily by other factors than CIA.

2. IV or oral iron treatment within 4 weeks prior to screening visit.

3. Erythropoietin treatment within 4 weeks prior to screening visit.

4. Blood transfusion within 4 weeks prior to screening visit.

5. Imminent expectation of blood transfusion on part of treating physician.

6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).

7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).

8. Known hypersensitivity to any excipients in the investigational drug products.

9. Subjects with a history of multiple allergies.

10. Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).

11. 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)).

12. Rheumatoid arthritis with symptoms or signs of active joint inflammation.

13. 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).

14. Planned elective surgery during the study.

15. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.

16. Known intolerance to oral iron treatment.

17. Untreated B12 or folate deficiency.

18. 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chemotherapy Induced Anaemia
• Neoplasms
• Non-myeloid Malignancies

Intervention

Drug:
• iron isomaltoside 1000
intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
• iron sulphate
oral, 200 mg per day (100 mg bid),12 weeks

Locations

Country	Name	City	State
India	Apollo Hospitals	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hb Concentration		Baseline week 4	No
Secondary	Change in Hemoglobin From Baseline to Week 24		24 weeks	No