EUCTR2012-001525-27-BG进行中（未招募）1 期
Phase IIa study to characterize the effects of the Spiegelmer® NOX H94 on anemia of chronic disease in patients with cancer
OXXON Pharma AG0 个研究点目标入组 48 人开始时间: 2012年6月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •The following inclusion criteria will be checked at the screening visit:
- •1.Written informed consent
- •2.Female or male aged >18 years
- •3.Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven malignancy, either hematological or solid tumor, of any grade or stage:
- •Hemoglobin (Hb) 7.0 g/dL to 10 g/dL,
- •Transferrin saturation (TSAT) <50%,
- •Serum iron <50 µg/dL (SI: <9.0 µmol/L)
- •Ferritin >30 ng/mL (SI: >30 µg/L)
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of =2
- •5.Estimated life expectancy =12 weeks
- •6.Men and women of reproductive potential must agree to use accepted contraception methods from screening throughout treatment and for 3 months after completion of treatment. Medically acceptable contraception methods are methods with a low failure rate of less than 1% per year.
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •The following exclusion criteria will be checked at the screening visit. In addition, exclusion criteria 16 to 20 will be checked again at Visit 2 prior to randomization / first study drug administration
- •1.Inability to personally provide written informed consent or to understand and collaborate throughout the study
- •2.History of pure red cell aplasia, thalassemia major or sickle cell disease
- •3.History of anemia unrelated to cancer <10 g/dL within 6 months prior to screening
- •4.Uncorrected iron deficiency
- •5.Regular need for blood transfusions at intervals <6 weeks
- •6.Acute or myeloid leukemia
- •7.Known or suspected chronic bleeding
- •8.Tumor with gastro-intestinal involvement without negative test for fecal occult blood
- •9.Suspected or known history of hemochromatosis
- •10.Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
- •11.Impaired liver function with bilirubin =2.0 mg/dL (26 µmol/L) or AST =2 times upper limit or ALT =2 times upper limit
- •12.History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic steatosis, hepatic cirrhosis, or organ transplantation
- •13.Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min (Cockcroft-Gault)
- •14.Known central nervous system malignancy or metastasis
- •15.Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure [BP] >150 mmHg or diastolic BP >100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
- •16.Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
- •17.Previous treatment with NOX H94 or treatment with an investigational agent <30 days prior to screening
- •18.Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to treatment start
- •19.Treatment with ESAs or RBC transfusions <21 days prior to treatment start
- •20.Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (lenalidomide up to 15 mg/d, thalidomide 50 mg per day, bortezomib once every 2 weeks, rituximab, interferon)
研究者
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