EUCTR2004-001417-33-DK进行中（未招募）不适用
A Randomized Open-Label Study of Darbepoetin alfa Administered Every Three Weeks with or without Parenteral Iron in Anemic Subjects with Nonmyeloid Malignancies Receiving Chemotherapy - AIM 3: Anemia and Iron Management with every 3 week dosing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 400
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
- •- non-myeloid malignancy (Chronic Myeloid Leukemia [CML], acute leukemia [AML & ALL], Hairy Cell Leukemia, Burkitt’s Lymphoma and lymphoblastic lymphoma are specifically excluded)
- •- planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening).
- •- hemoglobin concentration < 11 g/dL within 24 hours before randomization
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •- of legal age at the time written informed consent is obtained
- •- written informed consent must be obtained from the subject or legally accepted representative before any study-specific-procedure, including screening procedures, is performed
- •Are the trial subjects under 18?
- •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
- •- known (documented in medical records) history of seizure disorder (subjects with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and have not been taking anti-seizure medication for the previous 5 years)
- •- known (documented in medical records) history of thromboembolism
- •- known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (eg, sickle cell anemia, thalassemia)
- •- radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow
- •- unstable or uncontrolled disease/condition, related to or affecting cardiac function (eg, unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia)
- •- chronic inflammatory disease that is not stable (eg, rheumatoid arthritis, Crohn’s disease, peptic ulcer, ulcerative disease, etc)
- •- active bleeding
- •- clinically significant systemic infection
- •- inadequate renal and/or liver function (creatinine >2X ULN and/or transaminases >5X ULN )
- •- nutritional deficiency (defined as serum folate < 4.5 nmol/L (< 2.0 ng/mL) or vitamin B12 <148 pmol/L (< 200 pg/mL))
- •- iron deficiency (transferrin saturation < 15 % and serum ferritin < 10 ng/mL. (Subjects must have both to be excluded.)
- •- serum ferritin > 800 ng/mL (patients with serum ferritin > 500 ng/mL may only be enrolled if tranferring saturation < 30 %)
- •- known sensitivity to iron administration
- •- known (documented in medical records) positive HIV test
- •- previously suspected of or confirmed (documented in medical records) to have neutralizing antibodies to rHuEPO (eg, reasons to suspect including prolonged lack of response to previous erythropoietin therapy, pure red cell aplasia, inexplicably low reticulocyte counts following previous erythropoietin therapy, or other clinical evidence in the judgment of the investigator)
- •- received any red blood cell transfusion within 14 days before randomization or any planned red blood cell transfusion between randomization and study day 1.
- •- received any erythropoietic therapy within 4 weeks of randomization or any planned erythropoietic therapy between randomization and study day 1.
- •- other investigational procedures
- •- less than 30 days since receipt of any investigational drug or device (administered/used as part of an investigational study) that is not approved by the applicable regulatory authority (with the exception of Thalidomide)
- •- subject of reproductive potential is evidently pregnant (eg, positive serum HCG test) or is breast feeding
- •- subject of reproductive potential who is not using adequate contraceptive precautions
- •- subject has known sensitivity to any of the products to be administered during dosing.
- •- subject was previously randomized in this study
- •- subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
研究者
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