EUCTR2019-003573-26-BE进行中（未招募）1 期
Monocentric pilot trial evaluating efficacy of Trametinib in Arteriovenous Malformations that are refractory to standard treatments or for which standard treatment are contra-indicated - TRAMAV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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.Patients with complex and symptomatic fast-flow vascular malformations that are refractory to standard care such as medical treatment, surgical resection and/or embolization (ineffective or accompanied by major complications) or for wich standard care is contra-indicated.
- •2.Patients must have adequate bone marrow function: hemoglobine> 10,0 g/dl, neutrophils >1.500/mm³ and platelets > 100.000/mm³.
- •3.Patients must have the following laboratory values:
- •oTotal serum bilirubin = 1.5 x ULN (or totally bilirubin =3 x ULN with direct bilirubin = 1.5 x ULN in patients with well documented Gilbert Syndrome)
- •oSerum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN (or < 5.0 x ULN if hepatic metastases are present)
- •oSerum creatinine < 1.5 x ULN. If the serum creatinine is = 1.5 x ULN, then a 24-hour Creatinine Clearance must be conducted and the result must be = 60 mL/min.
- •4.Karnofsky score > 50
- •5.Negative urine pregnancy test in females with a childbearing potential.
- •6. Sexually active female patients (and female partners of male patients) must use adequate contraceptive measures while on study and for up to 8 weeks after ending treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.As AVM can result in impaired cardiac function, congestive heart failure is allowed if stabilized. New York Heart Association functional classification Grade 3-4 congestive heart failure should be excluded from this study, but remains at the discretion of the investigator as trametinib could indirectly improve cardiac function by controlling AVM. Other significant cardiac diseases, including unstable angina pectoris, ventricular arrhythmia, valvular disease with documented compromise in cardiac function, myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function, family history of congenital long or short QT, or known history of QT/QTc prolongation of Torsades de Pointes (TdP) are excluded from this trial.
- •2.Impairment of Gastro-Intestinal (GI) function or GI disease that may significantly alter the absorption of trametinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea = Grade 2, malabsorption syndrome, or small bowel resection)
- •3.Known hypersensitivity to drugs or metabolites from similar classes as study treatment.
- •4.Patient has (an)other concurrent severe and /or uncontrolled medical condition(s) that would, in the investigator’s judgement, contraindicate participation in the clinical study (e.g. acute or chronic pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function with a spirometry = 50% of the normal predicted value and/or O2 saturation = 88% at rest, etc.)
- •5.Patient with history of Retinal pigment epithelial detachments or Retinal vein occlusion
- •6.Immunocompromised patients, including known seropositivity for HIV
- •7. Pregnant or lactating women
研究者
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