EUCTR2013-005155-32-NL进行中（未招募）1 期
A phase 2, single arm, multi center trial evaluating the efficacy of the combination of sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma. - COSYMO
eiden University Medical Center0 个研究点目标入组 108 人开始时间: 2014年12月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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
- •-Pathologically proven conventional chondrosarcoma
- •-Or pathologically proven myxoid liposarcoma with PIK3CA mutation or PTEN loss
- •-Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
- •- Or pathologically proven clear cell chondrosardoma
- •-Patients of 18 years and up
- •-Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
- •-Adequate bone marrow function (Hb = 6.0 mmol/L, absolute neutrophil count = 1.5 x 109/L, platelets = 80 x 109/L)
- •-Availability of archival tumor material for central review
- •-Written signed informed consent
- •-Ability to adhere to the study visits and all protocol requirements
- •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 93
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •-Previously treated with an mTOR inhibitor
- •-Known to be allergic to cyclophosphamide
- •-Life expectancy of less than 3 months
- •-No measurable lesions according to RECIST 1.1
- •-ECOG Performance status >2
- •-Major surgery less than 4 weeks prior to start of treatment
- •-Known human immunodeficiency virus (HIV) positivity
- •-A decreased renal function with calculated GFR < 30 ml/min
- •-Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to an index (or target) lesion within 21 days prior to the first dose of study drug
- •-Pregnant or lactating women
- •-Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer
研究者
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