A Phase 2, Open-label Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumor (TET) Progressing After Primary Chemotherapy (SELECT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen.
This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (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
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)
- •Progression after Primary Chemotherapy
- •No more than two previous lines (Neoadjuvant or chemoradiotherapy will count as one 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 five half lives 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; Hemoglobin > 9.0 gm/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
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
- •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
研究组 & 干预措施
Selinexor
Open Label Selinexor 40 mg
干预措施: Open Label Selinexor (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: 24 months
To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.
次要结局
- Overall Response Rate(24 months)
- 6 Month Progression Free Survival Rate(6 months)
- 24 Month Overall Survival Rate(24 months)
- Adverse Events(24 months)