A Phase II, Non-comparative, Open Label, Multi-center Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study aims to investigate the clinical activity of sunitinib in patients with advanced thymic carcinoma who have failed chemotherapy.
详细描述
Sunitinib (Sutent®; Pfizer, New York, NY, USA) is a multitargeted tyrosine-kinase inhibitor (TKI) with activity against the stem cell-factor receptor (KIT) and platelet-derived growth-factor receptor (PDGFR), vascular endothelial growth-factor receptor (VEGFR), glial cell line-derived neurotrophic factor receptor (rearranged during transfection [RET]), colony-stimulating factor-1 receptor (CSF1R), and Fms-like tyrosine kinase-3 receptor (FLT3).
Sunitinib is a potent inhibitor of mutant KIT with additional inhibitory effects on VEGF receptors that potentially might make it more effective than imatinib against TCs. In the current version of NCCN guideline, sunitinib is suggested as one of the potential targeted therapeutics for advanced TCs.
We planned this study to investigate the clinical efficacy and tolerability of sunitinib in patients with advanced or recurrent TCs in Korean population. In addition, we will collect tumor samples and blood samples from patients for the further exploration of predictive biomarkers.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed, written and dated informed consent prior to any study specific procedures
- •Histopathologically confirmed metastatic or recurrent thymic thymic carcinoma
- •ECOG PS 0-2
- •Documented progressive disease after one or more conventional systemic chemotherapy
- •At least one measurable disease by RECIST v1.1
- •Adequate organ function for treatment as follows:
- •Absolute neutrophil count > 1.5 x 109/L
- •Platelets >100 x 109/L
- •Serum creatinine ≤ 2.0 x ULN (upper limit of normal)
- •Serum bilirubin ≤ 1.5 x ULN
- •AST and ALT ≤ 2.5 x ULN (without liver metastasis), ≤ 5.0 x ULN (with liver metastasis)
- •Life expectancy ≥ 12 weeks at day 1
排除标准
- •Previous treatment with sunitinib or other VEGF-TKIs
- •Any major operation or irradiation within 4 weeks of baseline disease assessment
- •Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
- •CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment (Asymptomatic CNS metastasis patients can be enrolled)
- •Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
- •Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
- •Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- •Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial. (including active bleeding, untreated DVT or thromboembolism)
研究组 & 干预措施
Sunitinib
Sunitinib will be administered orally at a dose of 50 mg once daily in 3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment.
干预措施: Sunitinib (Drug)
结局指标
主要结局
Objective response rate
时间窗: Up to 6 months
CR or PR by RECIST criteria version 1.1
次要结局
- Disease control rate(Up to 6 months)
- Progression-Free Survival(Up to 6 months)
- Overall survival(From first day of study treatment to day of any kind of death, assessed up to 24 months)
- Incidence of treatment related adverse events [Safety and Tolerability](Up to 6 months)
研究者
Jong-Seok Lee
Professor of Internal Medicine
Seoul National University Bundang Hospital