Clinical trial NCT01145638: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-myeloid Malignancies
Chemotherapy Induced Anaemia
Keywords: cancer
chemotherapy induced anaemia
iron
Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA)
CIA
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hb Concentration
timeFrame: Baseline week 4
Secondary outcomes:
measure: Change in Hemoglobin From Baseline to Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Apollo Hospitals
Study officials:
affiliation: Pharmacosmos A/S
name: Lars Lykke Thomsen, MD
role: STUDY_CHAIR
References:
citation: 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.