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
- non-myeloid malignancies associated with chemotherapy induced anaemia (CIA).MedDRA version: 12.1Level: LLTClassification code 10064014Term: Cancer anemia
- Registration Number
- EUCTR2009-016727-53-DK
- Lead Sponsor
- Pharmacosmos A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
1.Men and women, aged more than 18 years.
2.Subjects diagnosed with non-myeloid malignancies ( including all solid tumors,
Low Grade Lymphoma (LGL), Chronic Lymphatic Leukemia (CLL) and Myeloma)
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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method