Non-myeloid Malignancies, Chemotherapy Induced Anaemia
Conditions
Keywords
cancer, chemotherapy induced anaemia, iron, Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA), CIA
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.
Interventions
intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
DRUGiron sulphate
oral, 200 mg per day (100 mg bid),12 weeks
Sponsors
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hb Concentration | Baseline week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin From Baseline to Week 24 | 24 weeks |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iron Isomaltoside 1000 Iron isomaltoside intravenously as bolus or infusion
iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose | 231 |
| Iron Sulphate oral iron sulphate twice a day
iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks | 119 |
| Total | 350 |
Baseline characteristics
| Characteristic | Iron Isomaltoside 1000 | Iron Sulphate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 18 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 187 Participants | 101 Participants | 288 Participants |
| Region of Enrollment Denmark | 3 participants | 1 participants | 4 participants |
| Region of Enrollment Germany | 7 participants | 3 participants | 10 participants |
| Region of Enrollment India | 133 participants | 72 participants | 205 participants |
| Region of Enrollment Poland | 40 participants | 16 participants | 56 participants |
| Region of Enrollment Russian Federation | 29 participants | 18 participants | 47 participants |
| Region of Enrollment Spain | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Sweden | 5 participants | 3 participants | 8 participants |
| Region of Enrollment United States | 12 participants | 6 participants | 18 participants |
| Sex: Female, Male Female | 151 Participants | 90 Participants | 241 Participants |
| Sex: Female, Male Male | 80 Participants | 29 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 173 / 229 | 107 / 112 |
| serious Total, serious adverse events | 32 / 229 | 18 / 112 |
Outcome results
Primary
Change in Hb Concentration
Time frame: Baseline week 4
Population: The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Iron Isomaltoside 1000 | Change in Hb Concentration | 0.48 g/dL |
| Iron Sulphate | Change in Hb Concentration | 0.44 g/dL |
Secondary
Change in Hemoglobin From Baseline to Week 24
Time frame: 24 weeks
Population: The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Iron Isomaltoside 1000 | Change in Hemoglobin From Baseline to Week 24 | 1.60 g/dL |
| Iron Sulphate | Change in Hemoglobin From Baseline to Week 24 | 1.78 g/dL |