EUCTR2008-002113-48-GB进行中（未招募）1 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) - EXIST-2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 118
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
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) or sporadic LAM (biopsy-proven or compatible chest CT scan).
- •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 highly effective contraceptive measures, while on study and for 8 weeks after ending treatment.
- •6.Written informed consent according to local guidelines.
- •Non-interventional follow-up phase:
- •1. No angiomyolipoma progression at time of study treatment
- •discontinuation and no plan to continue treating their
- •angiomyolipoma(s) with systemic therapy
- •2. Non-interventional follow-up phase consent
- •Other protocol-defined inclusion criteria may apply.
- •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 101
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients with angiomyolipomas which, in the opinion of the investigator, requires surgery at the tiem of randomization.
- •2-Angiomyolipoma-related 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)
- •For patients with lymphangioleiomyomatois (LAM)
- •DLCO = 35%, or
- •O2 saturation below normal at rest, or
- •O2 saturation = 88% on 6 minute walking test with up to 6 litre O2/min 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 MRI 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).
- •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 conditons which could cause unacceptable safety risks or compromise compliance with the protocol.
- •Non-interventional follow-up phase:
- •1. Starting treatment with any mTOR inhibitor
- •2. Embolization immediately after discontinuing study treatment
- •3. Surgical resection of angiomyolipoma after discontinuing study
- •4. Prior kidney CT/MRI already performed 1-year after discontinuation of
- •Other protocol-defined exclusion criteria may apply.
研究者
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