EUCTR2009-016727-53-GB进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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A study to compare isomaltoside 1000 (Monofer®)(taken as injections) with iron sulfate taken as tablets in patients who have cancer and anemia caused by their treatment.Patients with non-myeloid malignancies associated with Chemotherapy Induced Anemia (CIA).MedDRA version: 15.1Level: LLTClassification code 10064014Term: Cancer anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 15.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2009-016727-53-DEPharmacosmos A/S350