EUCTR2012-005397-63-ES进行中（未招募）不适用
An open-label, multi-center, expanded access study of RAD001 in patients with angiomyolipoma associated with tuberous sclerosis complex (TSC)
ovartis Farmacéutica, S.A,0 个研究点开始时间: 2014年1月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Male or female ? 18 years of age.
- •2.Clinically definite diagnosis of tuberous sclerosis according to the modified Gomez criteria (Roach 1998, Hyman 2000, Table 5-1). Clinically definite diagnosis of tuberous sclerosis according to the modified Gomez criteria is defined as either of the following:
- •a.Two Major Features from Table 5-1.
- •b.One Major Feature plus two Minor Features from Table 5-1.
- •3.Clinically definite diagnosis of renal angiomyolipoma (according to local requirements)
- •4.Presence of at least one angiomyolipoma ? 3 cm in its longest diameter using CT/MRI. The choice of 3 cm reflects the vague limits between a justified wait and watch policy and the more proactive surgical intervention approaches.
- •5.If female and of child-bearing potential, documentation of negative pregnancy test prior to enrollment. Sexually active pre-menopausal female patients (and female partners of male patients) must use adequate contraceptive measures, while on study and for 8 weeks after ending treatment.
- •6.Written informed consent prior to any screening procedures according to local guidelines.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Patients with angiomyolipoma which, in the opinion of the investigator, requires surgery at the time of study inclusion
- •2.Angiomyolipoma-related bleeding or embolization during the 6 months prior to study inclusion
- •3.History of myocardial infarction, angina or stroke related to atherosclerosis.
- •4.Known impaired lung function (e.g. FEV1 or DLco ? 70% of predicted)
- •5.Significant hematological or hepatic abnormality (i.e., transaminase levels > 2.5 × upper limit of normal (ULN), serum bilirubin > 1.5 × ULN, hemoglobin < 9g/dL, platelets < 80,000/mm3, or absolute neutrophil count < 1,000/mm3).
- •6.Ongoing or active infection at the date of enrollment
- •7.Patients with a known history of HIV seropositivity.
- •8.Prior history of organ transplantation.
- •9.Recent surgery (involving entry into a body cavity or requiring sutures) within the 2 months prior to study inclusion.
- •10.Patient with a known hypersensitivity to RAD001 or other rapamycin analogs (sirolimus temsirolimus), or its excipients
- •11.Use of an investigational drug within the 30 days prior to study inclusion
- •12.Uncontrolled hyperlipidemia: Fasting serum cholesterol > 300 mg/dL (or > 7.75 mmol/L), AND fasting triglycerides > 2.5 × ULN.
- •13.Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 × ULN.
- •14.Patients with bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin).
- •15.Serum creatinine > 1.5 x ULN
- •16.Any severe and/or uncontrolled medical conditions which could cause unacceptable safety risks:
- •a.uncontrolled hypercholesterolemia/hypertriglyceridemia
- •b.Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).
- •17.For the purpose of MRI assessments:
- •a.Ferromagnetic metal implants other than those approved as safe for use in MR scanner (e.g., braces, some types of aneurysm clips, shrapnel)
- •b.Patients suffering from uncontrollable claustrophobia or physically unable to fit into the machine (e.g., obesity, etc).
- •Note: patients with vagal nerve stimulators are permitted to have CT assessments of angiomyolipoma unless local or national regulations do not permit this.
- •18.Inability to attend scheduled clinic visits and noncompliace with scheduled clinic visits required for toxicity management
- •19.Female patients who are pregnant or breast feeding, women of child-bearing potential, unless they are using effective methods of contraception during the study and for 8 weeks after ending treatment and sexually active males unless they use a condom during the study and for 8 weeks after the end of treatment.
- •20.Prior randomization to either arm of study CRAD001M2302
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