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临床试验/EUCTR2007-006997-27-DE
EUCTR2007-006997-27-DE进行中（未招募）不适用

A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/A

ovartis Pharma Services AG0 个研究点目标入组 99 人开始时间: 2010年1月20日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
99
研究概览入排标准研究者记录与标识符相似试验

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 of any 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).
  • •Clinically definite diagnosis 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. Presence of at least one SEGA lesion = 1.0 cm in its longest diameter using
  • •Note: SEGA lesions are only diagnosed in patients with TSC. They arise in the
  • •subependymal layer of the lateral ventricle and are always located near the
  • •foramen of Monro and enhance homogeneously with contrast on MRI with no
  • •evidence of surrounding edema.
  • •4. A recent MRI of the brain completed within 3 weeks (21 days) prior to the
  • •patient’s randomization must be compared with an MRI of the brain performed at
  • •an earlier stage of patient care (pre-baseline) and should demonstrate at least one of the following:
  • •a. Serial growth, defined as at least a 25% increase in SEGA volume, or
  • •b. Presence of a new SEGA lesion = 1 cm in its longest diameter, or
  • •c. New or worsening hydrocephalus defined by assessment of ventricular
  • •configuration changes, ventricular cap signs (periventricular edema) and
  • •qualitative assessment of CSF flow dynamics.
  • •If a previous MRI is not available, a comparative review of two previous CT scans is
  • •also acceptable to establish any of the above mentioned three conditions. In this
  • •case, baseline/screening MRI should still be performed.
  • •If only one prior CT scan was available, a second CT scan should be obtained to
  • •allow like to like comparison of cranial images. Again, the baseline MRI should still
  • •be performed. CT scans should be digitized and sent to the central reviewer for
  • •confirmation of eligibility.
  • •If the pre-baseline MRI or CT was only available on film (non-digital format) or
  • •software for volumetric assessment was not available at the local site, the local
  • •radiologist should make a qualitative assessment of the above-mentioned three
  • •criteria. The non-digital MRI or CT must also be sent to Central Radiology for
  • •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,
  • •excluding estrogen containing contraceptives, while on study.
  • •6. Written informed consent. Parents or legal guardians must sign the informed
  • •consent for patients under 18 years old and for patients with developmental
  • •delays. In addition, all minors aged 7 through 14 must sign an assent form, while
  • •minors aged 15 up to 17 must sign an assent line on the Informed Consent Form
  • •that will be signed by the parents or the legal guardians.
  • •Are the trial subjects under 18? yes
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1. Patients for whom SEGA related surgery is likely to be required, in the opinion of
  • •the investigator.
  • •2. Prior brain surgery.
  • •3. History of myocardial infarction, angina or stroke related to atherosclerosis
  • •4. Impaired lung function, defined as any of the following:
  • •a. FEV1 = 70% of predicted, or
  • •b. DLCO = 70% of predicted, or
  • •c. = 88% O2 saturation at rest in room air, or
  • •d. for patients unable to perform pulmonary function testing:
  • •i. clinical evidence of significantly impaired lung function, or
  • •ii. radiological evidence of significant lung disease other than LAM
  • •Note: Patients unable to perform a pulmonary function test (e.g. younger children,
  • •patients with developmental delay) will have a baseline chest CT scan performed
  • •5. Significant hematological or hepatic abnormality (i.e. transaminase levels > 2.5 x
  • •ULN or serum bilirubin > 1.5 x ULN, hemoglobin < 9 g/dL, platelets < 80,000/
  • •mm3, absolute neutrophil count < 1,000/mm3).
  • •6. Pregnancy or breast feeding.
  • •7. Intercurrent infection at date of randomization.
  • •8. Prior history of organ transplant.
  • •9. Recent surgery (involving entry into a body cavity or requiring sutures) within the
  • •2 months prior to randomization.
  • •10. Prior therapy with mTOR inhibitors (e.g.sirolimus, temsirolimus, everolimus).
  • •11. Use of an investigational drug within the 30 days prior to randomization.
  • •12. Uncontrolled hyperlipidemia: Fasting serum cholesterol > 300 mg/dL OR > 7.75
  • •mmol/L AND Fasting triglycerides > 2.5 x ULN.
  • •13. Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN.
  • •14. Patients with bleeding diathesis or on oral anti-vitamin K medication (except low
  • •dose warfarin).
  • •15. Patients with known history of HIV seropositivity.
  • •16. Inability to attend scheduled clinic visits.
  • •17. For the purpose of MRI assessments:
  • •a. Ferromagnetic metal implants (e.g., braces, some types of aneurysm clips,
  • •shrapnel) unless approved as safe for use in MR scanner
  • •b. Patients suffering from uncontrollable claustrophobia or physically unable to fit
  • •into the machine (e.g., obesity, etc).
  • •18. Serum creatinine > 1.5 x ULN.
  • •19. History of malignancy in the past two years, other than squamous or basal cell
  • •skin cancer.
  • •20. Use of estrogen containing medications.

研究者

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