EUCTR2007-003002-10-FR进行中（未招募）不适用
A multicentre phase II study, estimating the efficiency and the tolerance of RAD001 (Everolimus) , in patients with endometrial metastatic cancer resistant to a first line of chemotherapy - ENDORAD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Female
入选标准
- •Patients with an histologically proven diagnosis of endometrial cancer
- •Patients with metastatic disease after a first or a second chemotherapy line
- •Patients should have previously received a platinum-based treatment at adjuvant or metastatic stage
- •Patients with metastatic target lesions in non-irradiated zones
- •Patients with ECOG performance statut under or equal to 2 and adequate bone marrow function
- •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
- •Patients who have previously received experimental drugs (mTOR inhibitor)
- •Patients with local tumor relapse accessible by surgical treatment
- •Presence of medically uncontrolled brain metastases
- •Patients with prior diagnosis of malignancy except in situ cervix carcinoma or adequately treated and cured basal or spinal cell skin carcinoma, or other previous carcinoma diagnosed and cured more than 3 years before inclusion
- •High grade pneumonitis
- •Anti-vitamin K treatment
- •Patients with known hypersensitivity to everolimus or sirolimus (rapamycin) or lactosis (contained in RAD001 formulations)
- •Demencia or significantly altered mental status that could alter patient's compliance or understanding of informed consent discussion
- •Patients with an history of non-compliance to medical treatment
- •Administration, simultaneously or within the last 21 days, of another chemotherapy, or hormonotherapy, or any anti-tumoral drugs
- •Patients who have previously received molecules known to be iso-enzymes CYP3A stong inhibitors or inductors, within the last 5 days prior to inclusion
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