EUCTR2014-000501-13-BE进行中（未招募）1 期
Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib - Ph II CABOGIST in GIST
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 41 人开始时间: 2016年9月20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
- 41
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 diagnosis of GIST that is metastatic.
- •? Presence of at least one non-previously irradiated, measurable metastatic lesion as defined by RECIST 1.1
- •?Radiographic absence of a cavitating pulmonary lesion within 28 days prior to the first dose of cabozantinib
- •?Consent of the patient
- •?Failure on prior therapy with imatinib and sunitinib
- •?Male or female patient = 18 years of age
- •?ECOG performance status (PS) of 0-1
- •?Adequate bone marrow and organ function prior to receiving the first dose of study treatment
- •?Clinically normal cardiac function
- •?Patients must be able to swallow and retain oral film-coated tablets
- •?Recovery to baseline or = Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments
- •?Prior radiation therapy patients with clinically relevant ongoing complications from prior radiation therapy are not eligible
- •?Prior surgery:
- •- minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment is permitted
- •- Patients with clinically relevant ongoing complications from prior surgery are not eligible
- •? Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- •? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •?evidence of tumor or metastatic lesion invading the gastrointestinal tract within 28 days prior to the first dose of cabozantinib
- •?current evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
- •?Patient with tumor in contact with, invading or encasing a major blood vessel
- •?Prior use of tyrosine kinase inhibitors for the treatment of advanced GIST with the exception of imatinib and sunitinib
- •?Other investigational agents within 28 days before the first dose of study treatment
- •?History of congenital long QT syndrome
- •?QTcF> 500 msec within 1 month before the first dose of study treatment
- •?Congestive heart failure
- •?History of unstable angina, clinically significant cardiac arrhythmias and myocardial infarction within 6 months prior to the first dose of protocol treatment
- •?Poorly controlled hypertension
- •?Concomitant anticoagulation at therapeutic doses with oral anticoagulants
- •?Specific contraindications for treatment with cabozantinib
- •?stroke and thromboembolic event requiring therapeutic anticoagulation within 6 months before the first dose of study treatment
- •?Gastrointestinal disorders associated with a high risk of perforation or fistula formation
- •?Evidence of significant active bleeding or bleeding diathesis within 6 months before the first dose of study treatment
- •?Hemoptysis = 0.5 teaspoon of red blood within 3 months before the first dose of study treatment
- •?Signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
- •?Prior radiation therapy:
- •-radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before the first dose of study treatment.
- •-systemic treatment with radionuclides within 6 weeks before the first dose of study treatment.
- •?Prior surgery major surgery or trauma within 12 weeks prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer.
- •? Active infection requiring systemic treatment within 28 days before the first dose of study treatment.
- •? History of organ transplant.
- •? Concurrent severe, clinically relevant hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
- •?History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix and non-metastatic, non-melanoma skin cancer
- •?Patients requiring chronic concomitant treatment with strong Cytochrome P450 (CYP) 3A4 inducers
- •?Lactating females
研究者
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