NCT03466827Unknown2 期
A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
Morten Mau-Soerensen4 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2017年10月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Overall Response Rate
研究概览
简要总结
The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen.
This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients).
There are two study arms:
Arm A: Thymoma
- Stage 1: 15 patients
- Stage 2: 10 patients
Arm B: Thymic carcinoma
- Stage 1: 15 patients
- Stage 2: 10 patients
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced TET (thymoma or thymic carcinoma)
- •Inoperable per local Investigator (Masaoka Stage III or IV)
- •Progression after treatment with least one platinum containing chemotherapyregimen
- •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 interval from any investigational agents or cytotoxic chemotherapy to start of study is required
- •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
- •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 3 months after participation in this study
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
结局指标
主要结局
Overall Response Rate
时间窗: 24 months
To determine the overall response rate according to RECIST 1.1
次要结局
- Progression Free Survival(6 months)
- Adverse Events(24 months)
研究者
Morten Mau-Soerensen
Chief Physician, MD, PhD
Rigshospitalet, Denmark
研究点 (4)
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