EUCTR2010-020451-32-NL进行中（未招募）不适用
Pilot study of everolimus in the treatment of advanced malignancies in patients with Peutz-Jeghers syndrome - EVAM
Academic Medical Center Amsterdam0 个研究点开始时间: 2010年8月11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
- •Known Peutz-Jeghers disease (with LKB1 mutation)
- •Advanced malignancy of any tumor type, not suitable for surgery at the time of study enter
- •No concurrent systemic anti cancer treatment
- •No prior treatment with m-TOR inhibitor
- •Patients with prior malignancies or concurrent second malignancies are eligible
- •Prior systemic therapy is permitted with a washout time of at least 4 weeks
- •Cytological or histological confirmed carcinoma
- •Metastatic or non-resectable disease
- •Patients with clinically and/or radiographically documented measurable lesion according to RECIST criteria:
- •X-ray, physical exam> 20 mm
- •Spiral CT scan> 10 mm
- •Non-spiral CT scan > 20 mm
- •ECOG/ WHO performance 0-2
- •Age > 18 years
- •Life expectancy > 3 months
- •Adequate renal function (creatinine < 150 µmol/L)
- •Adequate liver function (bilirubin < 1.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases
- •Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Patients who are pregnant or lactating
- •Patients who are of childbearing potential who do not agree to use a reliable contraceptive method throughout the study
- •Patients who do have serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
- •Patients who are not willing to sign the Signed informed consent according to ICH/GCP, IRB approval obtained prior to treatment
- •Patients who do have uncontrolled symptomatic hyperglycaemia
研究者
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