NL-OMON37228已完成3 期
A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - AML 2302
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 et al, 1998; Hyman and Whittemore,
- •2000, Table 5-1) ) or sporadic LAM (biopsy-proven or compatible chest
- •CT scan). Clinically definite diagnosis of tuberous sclerosis according to the
- •modified Gomez criteria is defined as either of the following:
- •* Two Major Features from Table 5-1.
- •* One Major Feature plus two Minor Features from Table 5-1.
- •3. Clinically definite diagnosis of renal angiomyolipoma.
- •4. Presence of at least one angiomyolipoma * 3 cm in its longest diameter
- •using CT or MRI.
- •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 according to local guidelines.
排除标准
- •1. Patients with angiomyolipomas which, in the opinion of the investigator, requires surgery at the time of randomization.
- •2. Angiomyolipoma-related bleeding or embolization during the 6 months prior to randomization.
- •3. History of myocardial infarction, angina or stroke related to atherosclerosis.
- •4. Impaired lung function, defined as any of the following:
- •For patients without lymphangioleiomyomatosis (LAM)
- •Known impaired lung function (e.g. FEV1 or DLco * 70% of predicted)
- •Note: pulmonary function testing at baseline is not required for patients
- •without LAM
- •For patients with lymphangioleiomyomatosis (LAM)
- •* DLCO *<35%, or
- •* O2 saturations below normal at rest, or
- •* O2 saturation *<88% on 6 minute walking test with up to 6 liter O2/minute
- •nasal oxygen
- •5. Chylous ascites sufficient to affect diaphragmatic function or pulmonary function testing.
- •6. Significant hematological or hepatic abnormality (i.e., transaminase levels > 2.5 × the upper limit of normal (ULN), serum bilirubin > 1.5 × ULN, hemoglobin < 9g/dL, platelets < 80,000/mm3, or absolute neutrophil count (ANC) < 1,000/mm3).
- •7. Pregnancy or breast feeding.
- •8. Intercurrent infection at date of randomization.
- •9. Prior history of organ transplantation.
- •10. Recent surgery (involving entry into a body cavity or requiring sutures) within the 2 months prior to randomization.
- •11. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus).
- •12. Use of an investigational drug within the 30 days prior to randomization.
- •13. Uncontrolled hyperlipidemia: Fasting serum cholesterol > 300 mg/dL (or >7.75 mmol/L ) AND fasting triglycerides > 2.5 × ULN.
- •14. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 × ULN.
- •15. Patients with bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin).
- •16. Patients with a known history of HIV seropositivity.
- •17. Inability to attend scheduled clinic visits.
- •18. For the purpose of MRI assessments:
- •* Ferromagnetic metal implants other than those approved as safe for use in MR scanner (e.g., braces, some types of aneurysm clips, shrapnel).
- •* 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.
- •19. Serum creatinine > 1.5 × ULN.
- •20. History of malignancy in the past two years, other than squamous or basal cell skin cancer.
- •21. Any severe and/or uncontrolled medical conditions which could cause
- •unacceptable safety risks or compromise compliance with the protocol, such
- •1. * Grade 3 hypercholesterolemia/hypertriglyceridemia or * Grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment if given)
- •2. 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).
- •3. Active skin, mucosa, ocular or GI disorders of Grade > 1
研究者
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