A phase III, randomized, open-label study of intravenous iron isomaltoside 1000 (Monofer®) as mono therapy (without erythropoeisis stimulating agents) in comparison with oral iron sulfate in subjects with non-myeloid malignancies associated with Chemotherapy induced anaemia (CIA). - P-Monofer-CIA-01

• Conditions: on-myeloid malignancies associated with Chemotherapy induced anaemia (CIA); MedDRA version: 12Level: LLTClassification code 10064014Term: Cancer anemia

• Registration Number: EUCTR2009-016727-53-GB
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-01
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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 2.
7. Willingness to participate after informed consent (including HIPAA, if
applicable).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Anaemia caused primarily by other factors than CIA.
2. IV or oral iron treatment within 4 weeks prior to screening visit.
3. Erythrypoietin 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 enrolment 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 and hepatitis (alanine aminotransferase (ALAT) >
3 times upper normal limit).
11. History of Immunocompromise and/or history of Hepatitis B and/or C.
12. 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)).
13. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
14. 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).
15. Planned elective surgery during the study.
16. Participation in any other clinical study (except chemotherapy protocol) within
3 months prior to screening.
17. Known intolerance to oral iron treatment.
18. Untreated B12 or folate deficiency.
19. 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified