EUCTR2016-002612-40-DK进行中（未招募）1 期
A phase II study of selinexor (KPT-330) in patients with advanced thymic epithelial tumour (TET) progressing after primary chemotherapy. - Thymoma
Department of Oncology Rigshospitalet0 个研究点目标入组 50 人开始时间: 2016年8月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •-Histologically confirmed advanced TET (thymoma or thymic carcinoma)
- •-Progression after primary chemotherapy
- •-Not more than 2 previous lines (neoadj or chemoradiotherapy will count as 1 line if disease progression has occurred within 6 months.
- •-Inoperable per local Investigator (Masaoka Stage III or IV)
- •-Progression after treatment with least one platinum containing chemotherapy regimen
- •-Measurable disease (RECIST 1.1)
- •-Age =18 years
- •-ECOG PS <2
- •-Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug unless toxicity is stable.
- •-A 4 weeks or 5 half lifes interval from any investigational agents or cytotoxic chemotherapy to start of study is required (whichever is shorter)
- •-Signed informed consent
- •-Adequate bone marrow function and organ function:
- •-Hematopoietic function: total white blood cell count (WBC) = 3000/mm³, absolute neutrophil count (ANC) = 1500/mm³, platelet count = 100,000/mm², circulating lymphocytes < 50,000/mm³, Haemoglobin >=9.0mmol/dL
- •-Hepatic function: bilirubin < 1.5 times the upper limit of normal (ULN), ALT < 2.5 times ULN or ALT < 5.0 times ULN in the presence of liver metastases
- •-Creatinine clearance > 30 ml/min according to Cockcroft-Gault
- •-Patients of childbearing potential must agree to use adequate birth control during and for 7 months after participation in this study
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •No significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy, including
- •-Unstable cardiovascular function
- •-Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
- •-Markedly decreased visual acuity
- •-Active infection requiring intravenous antibiotics
- •Pregnancy or breast-feeding
- •Symptomatic brain metastasis requiring corticosteroids
- •Uncontrolled autoimmune disorders. Patients with autoimmune disorders under control on medication may be included. Patients with pure red cell aplasia may be included if haemoglobin levels are relatively stable on transfusions or medication
- •Any other cancer (excluding radically operated localised squamous skin cancer) with clinical activity within the last 2 years
- •Significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications
- •No dehydration of NCI-CTCAE grade = 1
- •Serious psychiatric or medical conditions that could interfere with treatment.
- •No history of organ allograft
- •No concurrent therapy with approved or investigational anticancer therapeutics
研究者
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