EUCTR2012-001525-27-AT进行中（未招募）不适用
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5月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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 must agree to follow effective contraception methods during treatment and for 3 months after completion of treatment. Women of childbearing potential must agree to use two forms of effective contraception during treatment and for 3 months after completion of treatment.
- •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
相似试验
进行中（未招募）
1 期
Phase IIa study to investigate the efficacy of NOX-H94 in the treatment of anemia in patients with cancer.EUCTR2012-001525-27-BGOXXON Pharma AG48
招募中
2 期
Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Multiple Myeloma or LymphomaD63.0Anaemia in neoplastic diseaseAnemia of Chronic DiseaseDRKS00004366OXXON Pharma AG48
已完成
2 期
An exploratory phase 2 study to asses the effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in subjects with type 2 Diabetes who have inadequate glycemic and blood pressure (BP) control.Diabetes Mellitus Type 210018424NL-OMON33243Bristol-Myers Squibb15
招募中
2 期
A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapyadvanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapyJPRN-UMIN000018484HO HOKKAIDO CANCER CENTER Division of Gastroenterology57
进行中（未招募）
1 期
VAC071: A study to assess efficacy of the ChAd63/MVA PvDBP vaccinesPlasmodium vivax malariaMedDRA version: 20.0Level: LLTClassification code 10047665Term: Vivax malaria (benign tertian)System Organ Class: 100000004862EUCTR2019-000643-27-GBniversity of Oxford / Clinical Trials and Research Governance19